ATDEPARTMENT OF HEALTH AND HUMAN SERVICES

 

FOOD AND DRUG ADMINISTRATION

 

CENTER FOR DEVICES AND RADIOLOGIC HEALTH

 

 

 

 

 

 

 

 

 

 

 

GENERAL AND PLASTIC SURGERY DEVICES PANEL

 

OF THE MEDICAL DEVICES ADVISORY COMMITTEE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Wednesday, October 15, 2003

 

7:30 a.m.

 

 

 

 

 

 

 

 

 

Gaithersburg Marriott Hotel

9751 Washington Blvd.

Gaithersburg, Maryland

P A R T I C I P A N T S

 

Thomas V. Whalen, M.D., Acting Panel Chairperson

David Krause, Ph.D., Executive Secretary

 

VOTING MEMBERS:

 

Brent A. Blumenstein, Ph.D.

Phyllis Chang, M.D.

Michael A. Choti, M.D.

Ann Marilyn Leitch, M.D.

Michael J. Miller, M.D.

Amy E. Newburger, M.D.

 

CONSUMER REPRESENTATIVE:

 

Alisa M. Gilbert

 

INDUSTRY REPRESENTATIVE:

 

Debera M. Brown

 

TEMPORARY VOTING MEMBERS:

 

Benjamin O. Anderson, M.D.

Dennis W. Boulware, M.D.

Emily F. Conant, M.D.

Nancy A. Dubler, LLB

Ruth A. Lawrence, M.D.

Stephen Li, Ph.D.

Ellice S. Lieberman, M.D.

Barbara R. Manno, Ph.D.

Mary H. McGrath, M.D., MPH

Michael J. Olding, M.D.

 

Celia Witten, Ph.D., M.D., FDA

 

C O N T E N T S

 

Call to Order and Introductions,

   Thomas V. Whalen, M.D.    5

 

Open Public Comment:

 

   Virginia Silverman    11

 

   Dr. Marie Pletsch    13

 

   Dr. Philip C. Haeck    16

 

   Susan Schambeck    20

 

   Julie Godoy (read by J. Rosanna)    22

 

   Holly A. Feustel    27

 

   Dr. Elvin G. Zook    29

 

   Ruby Rahn    32

 

   Donna Sims (read by Nicole Rudick)    35

 

   Dr. Karen Becker    38

 

   Lale Goddard (read by Ruby Rahn)    41

 

   Teresa Hamilton (read by Erica Clare)    44

 

   Cheryl Robinson    47

 

   Linda Dintino (read by Stephanie Donny)    50

 

   Rebecca J. Smith-Miles    52

 

   Myrl Jeffcoat (read by Pam Dowd)    54

 

   Elaine Donnelly (read by Kathleen Witter)    57

 

   Rogene Schorer (read by Georgiana Hanson)    60

 

   Wanda Simison (read by Sibyl Goldrich)    63

 

   Lois A. Travis (read by Jan Erickson)    66

 

   Deborah Guillory (read by Jennifer Cook)    70

 

   Gerie A. Voss    71

 

   Susan Pope Helman    74

 

   David Helman    78

C O N T E N T S (Continued)

PAGE

Open Public Comment: (Continued)

 

   Dr. Christopher Batich    79

 

   Marilyn Malnack    87

 

   Leslie A. Rumsey    90

 

   Nikki Dollie    92

 

   Mike Dollie    96

 

   Dr. Ernest Lykissa    96

 

   Audrey Sheppard    108

 

   Dr. Elizabeth Connell    110

 

   Dr. T. Wade Clegg, III (read by Erin Hemstra)    116

 

   Lynda Roth, Coalition of Silicone Survivors    118

 

   Dr. Jane Zones, Breast Cancer Action    123

 

   Cynthia Pearson, National Women's

      Health Network    128

 

   Mary Dickerson    133

 

   Joe Kelly, Dads and Daughters    134

 

   Jama K. Russano, Children Afflicted

      with Toxic Substances    141

 

   Rodney Hayton, National Silicone

     Implant Foundation    147

 

   Dr. Carolyn Kerrigan, Plastic Surgery

     Educational Foundation    150

 

   Dr. James H. Wells, American Society of

      Plastic Surgeons    158

 

   Mary McDonough, In the Know    169

 

   Dr. Diana Zuckerman, National Center for Policy

      and Research for Women and Families    172

 

Open Panel Discussion     183

 

Sponsor Summation, Scott Spear, M.D.    228

 

Concluding Panel Deliberations and Vote    266

P R O C E E D I N G S

Call to Order and Introductions

    DR. WHALEN:  Welcome to the second day of the General and Plastic Surgery Devices Advisory Panel.  I would like to ask the panel members to give a brief reintroduction of themselves with their area of particular expertise as it relates to this PMA, starting to my right with Dr. Choti.

    DR. CHOTI:  Michael Choti.  I am a general surgeon in surgical oncology at Johns Hopkins Hospital, and my interest is in clinical cancer surgery.

    DR. BLUMENSTEIN:  Brent Blumenstein, biostatistician working independently.

    DR. CONANT:  Emily Conant, Associate Professor of Radiology, University of Pennsylvania.  I am a breast imager, chief of breast imaging there.

    DR. LIEBERMAN:  Ellice Lieberman.  I am an associate professor of obstetrics and gynecology, Harvard Medical School, and Associate Professor of Maternal and Child Health at the Harvard School of Public Health, and my expertise is in epidemiology.

    DR. MANNO:  I am Dr. Barbara Manno, from the Louisiana State University Medical Center, in Shreveport, Louisiana.  I am a professor in the Department of Psychiatry.  My background is toxicology and my sub-specialty within toxicology these days is forensic toxicology.

    MS. BROWN:  I am Debera Brown, the Vice President of Regulatory Affairs for Broncus Technologies.  I am the industry representative for this panel, and I have had over 20 years of experience in medical device development.

    MS. GILBERT:  I am Alisa Gilbert.  I am the consumer representative.  I am also a breast cancer survivor and founder of the Unbroken Circle in the Office of Native Cancer Survivorship.

    DR. WITTEN:  I am Celia Witten.  I am the Division Director of the Reviewing Division at FDA for these products.

    DR. MILLER:  I am Michael Miller.  I am Professor of Plastic Surgery at the University of Texas MD Anderson Cancer Center.

    DR. ANDERSON:  Ben Anderson, breast cancer surgeon, surgical oncologist from the University of Washington in Seattle.

    DR. LI:  Steve Li, President of Medical Device Testing and Innovations in Sarasota, Florida and my areas are biomaterials and biomechanics.

    PROF. DUBLER:  Nancy Dubler.  I am Director of the Division of Bioethics at Montefiore Medical Center, and a professor of Epidemiology and Population Health at the Albert Einstein College of Medicine.

    DR. NEWBURGER:  I am Amy Newburger.  I am in private practice in dermatology, in New York.  I teach at St. Luke's Roosevelt Hospital Medical Consortium.

    DR. BOULWARE:  I am Dennis Boulware, professor of medicine, University of Alabama, at Birmingham, and a rheumatologist.

    DR. LEITCH:  I am Marilyn Leitch.  I am a surgical oncologist and professor of surgery at the University of Texas Southwestern Medical Center, in Dallas.

    DR. CHANG:  Good morning.  I am Phyllis Chang, plastic surgeon and an associate professor in the Department of Surgery at the University of Iowa College of Medicine.

    DR. KRAUSE:  My name is David Krause.  I am the executive secretary of this panel and I am also in the branch that reviews these devices.

    DR. LAWRENCE:  I am Ruth Lawrence, University of Rochester School of Medicine, Department of Pediatrics and Ob/Gyn.  I am a pediatrician, clinical toxicologist, and my special interest is newborns and breast feeding.

    DR. WHALEN:  Thank you.  I am Tom Whalen.  I am Professor of Surgery and Pediatrics at Robert Wood Johnson Medical School and the Acting Chair for this Panel.

    There are brief housekeeping attention details that probably need to be presented in a little while when more people come in.  For those who did not stay until the end last night, the panel did conclude the scheduled day's business and did get through the FDA questions.  I will very briefly go over the results of those deliberations as we begin this afternoon's activities before the panel has final deliberations and voting.

    What we are about this morning is further public testimony that will probably take up the entire morning until the lunch break, which will be about midday or perhaps slightly later.  We will then have final summation and closing by FDA and then by sponsor and then the panel will deliberate.

    To reiterate something that I said yesterday, which apparently was not heard by many people, please either turn off your cell phones or place them on silent mode because it is extraordinarily rude to have them continuously going off when we are trying to hear people who have significant messages to give us from the podium, and the panel's deliberations as well.

    We now will proceed with today's open public comment session.  All persons addressing the panel are asked to speak clearly into the microphone as the transcriptionist is dependent upon this means of providing an accurate record of this meeting.  I would specifically now like to have the attention of all the individuals who are registered to speak to the panel today.  You have all been given a number corresponding to your order of appearance.  Please come to the podium area in advance so that we are not spending a great deal of time in transitions from speaker to speaker.  Specifically, we would ask that the speaker who is next to speak be in the corridor between the chairs, towards the end of that corridor, as the person is speaking at the podium.

    I would also like to remind you that we will have a timer to help you remain on time.  In view of the large volume of people who are going to speak to us today, it will need to be rigorously enforced and I apologize in advance for intrusions upon you if you extend beyond your allotted time.  At the 30-second mark there will be a yellow continuous light that comes on in front of you, and then a red light at the conclusion of that time.

    I would finally like to address the issue of financial disclosure.  Both the FDA and the public believe in a transparent process for information gathering and decision-making.  To ensure such transparency at the open public hearing session of the advisory committee meeting, FDA believes that it is important to understand the context of an individual's presentation.

    For this reason, FDA encourages you, the open public hearing speaker, at the beginning of your written or oral statement to advise the committee of any financial relationship that you may have with the sponsor, its product and, if known, its direct competitors.  For example, this financial interest information may include the sponsor's payment of your travel, lodging or other expenses in connection with your attendance at the meeting.  Likewise, FDA encourages you at the beginning of your statement to advise the committee if you do not have any such financial relationships.  If, however, you choose not to address this issue of financial relationships at the beginning of your statement, it will not preclude you from speaking.

    We will start with those individuals who have notified the FDA of their request to present in the open session.  Speaker number one, please come to the podium.

Open Public Comment

    MS. SILVERMAN:  Good morning.  My name is Ginger Silverman.  I am from California, and Inamed provided me transportation and my accommodations for coming to the meeting.

    Twenty-four months ago I was diagnosed with ductal carcinoma in situ, breast cancer.  That is the bad news.  The good news is that I basically had breast cancer for about seven days.  Because of my familiarity with the disease, all the statistics, my knowledge of the options that were available to me and the possible outcomes, I chose the most aggressive treatment available to me at the time.  I had a double mastectomy two years ago, and that happened one week after my radiologist's phone call.

    As a result of my early diagnosis and my aggressive proactive choices, I now have silicone breast implants and did not need radiation or chemotherapy.  The discovery of, and subsequent process of ridding my body of breast cancer held many miracles.  Finding the right doctors is probably at the top of the list; embracing the love of my friends and family who gathered around to support me through the ordeal; and learning a lot about myself, my courage.

    Surprisingly, my ability to heal was facilitated in an unanticipated way, my selection of silicone breast implants.  My plastic surgeon recommended them because I chose immediate breast reconstruction and I wanted to have the most natural look possible.  I have no uncomfortable side effects and I could not be happier with the results.  They have actually helped me in my process of recovering my life.

    I have a five-year old daughter.  Her name is Eve, and she has just started kindergarten.  She looks at life through very impressionable eyes and I made it my life's mission to be a healthy role model for her as I made it through the past two years.  I wanted her to see that she had a choice in the way that she dealt with adversity, and choice is the operative word in that.  Women who choose or need breast implants for any reason should be allowed to make an informed decision on the type of implant they choose.  Silicone breast implants are available in many other countries outside of the United States but no woman should be forced to leave the country in order to satisfy her choice.

    Just as I teach Eve she can choose the way that she lives her life, I am asking you to please let American women have the choice of what implants to put into their own bodies.  They have a right to make the recovery of their lives the best that it can possibly be.  Thank you very much.

    DR. PLETSCH:  Dr. Whalen, advisory panel, my name is Dr. Marie Pletsch.  I am a board-certified plastic surgeon and have been in private practice in Santa Cruz and Monterey, California for the last 34 years.  I took care of my own expenses to come to this meeting.  My only connection with Inamed is that I have been an investigator in their core study for silicone gel breast implants, and I have also been an investigator for some of their competitors.  I am not a witness nor a party in a pending lawsuit regrading these implants.

    I am grateful for having had silicone implants available to me when I was diagnosed with breast cancer in 1988 and underwent bilateral mastectomies and reconstruction.  The original implants were replaced in 1991, using McGhan, now Inamed, anatomic or shaped implants, not because there was anything wrong with the first set of implants but because I was undergoing a revision of my reconstruction and I requested changing of the implants for a larger size and more anatomical shape.  Please note, reoperation is not necessarily an indication that there is something wrong with the implant.

    I may be the only presenter before this panel that can boast a unique combination of having implanted approximately 1,000 women with silicone gel breast implants and over 200 of these have been since the restrictions in 1992.  In addition to that, I have implanted approximately 500 women with saline implants.  Added to this, I am a female plastic surgeon with implants myself and this gives me a more intimate view of the situation both from a patient's and a surgeon's viewpoint.

    When asked by my patients and the press, are these implants safe?  I confidently answer yes.  If they were not safe, do you believe that I would keep these implants and would not have them removed, and why would I continue to use them?  I have implanted silicone gel breast implants since the mid-1960s and since 1992 I have used them every time the FDA protocol allows them to be used.

    What I believe is a tragedy is the harm that has come to American women in many ways because of these restrictions.  I will list several of them.  First, many women were falsely frightened about effects of silicone implants and many had unnecessary surgery to remove them.  Some did not replace them with anything and were consequently deformed, causing physical and psychological damage.  Others replaced them with saline implants, only to find out saline wrinkled and sometimes deflated.  Some of these women then requested replacement implants with silicone again.

    Secondly, some women with various diseases have erroneously been led to believe that their illnesses were due to breast implants when, in fact, they were due to other causes.

    Thirdly, women who could afford it left the country to go to other countries that allow these implants.

    DR. WHALEN:  Doctor, you need to conclude, please.

    DR. PLETSCH:  American women apparently do not have the right to choose the type of implants.  The rest of the world uses these 95 percent of the time.  I was in Germany in 1998 at the ECWON meeting and they were shocked and horrified by the actions of the FDA.  I ask you to look at the scientific facts and to encourage the FDA to lift the restrictions.  Thank you.

    DR. HAECK:  My name is Phil Haeck.  I am a board-certified plastic surgeon, practicing in Seattle, Washington.  I have been in practice for 18 years and I am a plastic surgeon without implants.

    I am the editor of Plastic Surgery News, the monthly news magazine of the American Society of Plastic Surgeons.  This organization has paid my travel expenses to be here today.  I have no financial interest in any device manufacture or their subsidiaries of affiliates.  Breast surgery accounts for approximately 20 percent of my practice.

    I am going to address the issue of reoperation in breast augmentation surgery since it has not been given an adequate airing here from the standpoint of the surgeon.  Plastic surgeons dealing with the challenges of a practice in breast surgery are not at all surprised at the reoperation rates reported here yesterday.

    So, this is what I tell my patients who have decided to undergo a breast augmentation procedure:  You are about to begin on a road to satisfaction.  To get there may mean more than just the one surgery, the one you and I have planned.

    There are only two reasons for immediately going back to the operating room in the first few days after breast surgery.  Severe bleeding is extremely rare but if it is severe and results in a collection of blood around the implant a hematoma may occur.  Most of those will need to be drained in a short second operation.

    Likewise, an infection around the implant will need a short operation to drain the liquids off and possibly remove the implant for a week or more.  It can then safely be replaced.  Both of these are extremely rare problems that happen in less than one percent of cases.

    All other reasons for reoperation happen later, over the time period of three to twelve months after the operation, or rarely, even years later when an implant fails.

    Capsular contracture can and does occur.  You should expect that it could occur anywhere from three to ten percent of my patients, but if it happens to you and you need reoperation, then it will feel more like it is 100 percent, and it may be painful both before and after reoperation.

    After this, the reasons relate to just two categories:  My skills in correcting your preexisting asymmetry of your breasts, or the way in which your body healed or didn't heal correctly after the surgery.

    It is a rare patient that arrives in my office requesting breast surgery who feels she has a perfect match between her left and right breasts.  Many have quite a different appearance from side to side.  You are probably expecting perfection and it is my intention to give that to you, but there is always the chance that what seemed like adequate correction at the time of surgery may not prove later to be to your or my liking.

    I tend to prefer to err on the conservative side since that is always easier to adjust later.  Complex intraoperative decisions about the modification of the infra-mammary fold, release of the pectoral muscle, re-positioning of a drooping nipple, and differential sizing of the implants may not turn out in the healing phase to have been exactly what was needed to provide a mirror image.

    The more extreme the preoperative differences from side to side, the greater the likelihood that a second operation will be needed.  Nevertheless, these secondary surgeries are not drastic operations and frequently can be performed with local anesthesia.  The patient usually returns to her normal routine within 48 hours or less, and I do not charge the patient a professional fee for these surgeries.

    The difficulty here, in my opinion, is that we look at any reoperation as a statistic.  But breast augmentation surgery is a unique situation in the realm of all surgical procedures.  Lumping and minor scar revision go into data that also holds statistics for implant failures and reoperations for ruptures--

    DR. WHALEN:  Doctor, you need to conclude.

    DR. HAECK:  --which gives a dangerously over-jaded look into this situation.  We are in a unique predicament here that does not have the morbidity precedent in another area of surgery.  As long as both the surgeon and the patient expect perfection from this operation, there will always be another patient on tomorrow's surgery schedule somewhere who is not undergoing her first surgery.  Thank you.

    MS. SCHAMBECK:  Good morning.  My name is Susan Schambeck.  I am the recipient of gel implants made by Inamed Corporation.  Inamed has provided my travel and lodging expenses here.

    I would like to share my story with the panel.  I decided to have breast surgery in 1995.  I feel that my decision was well thought out, and my research led me to Dr. Pletsch, in Santa Cruz, California.  I was 36 years old and the mother of a two-year old son, Norton.  I had nursed him for a little more than a year and felt confident that giving him that kind of healthy start in life was a gift.  I felt complete with having one child to leave my legacy to and it was time to give myself a gift.  Since I have always been athletic and outgoing, I saw an opportunity to get my body back into balance.  Dr. Pletsch was very helpful in that process.  I knew that I was a good candidate for breast augmentation.  I knew that it would be a significant boost for my self-esteem and personal image.  These are the best years of my life and it is very important to have choices.

    I had my surgery in February of 1995.  My only choices were to have saline implants or live with the effects of nursing my son.  I chose the saline implants.  The end result of that procedure was that I had severely wrinkled implants that looked and felt unnatural.  In July of 1999 one of the implants ruptured.  After discussing my options with Dr. Pletsch and my family, I was able to choose an upgrade to silicone gel implants.

    I realized the difference in the look and feel of the silicone gel immediately.  It was far superior to the saline.  I am convinced that if I had had a choice, I would have chosen the silicone gel over the saline.  I didn't like the feeling of wrinkled water bags in my body.  They caused me to feel self-conscious.  With the silicone gel implants I feel that I have a very balanced and natural shape.  Nothing about the silicone gel feels unnatural.  The consistency is as close to the real thing as it gets and I am very happy with the result.

    I sincerely wish that every woman who is considering an enhancement or reconstructive surgery could some day have real choices from the beginning of her journey.  I personally feel honored to assist in that process.  It doesn't seem fair to me to require two surgeries in order to achieve a choice.  I am very happy and healthy with the gel implants.  It is difficult for me to reflect back on the emotional and financial burden that I have survived simply because I didn't have a choice in the beginning.  Please allow us to have choices.  Thank you.  I have copies for the panel.

    DR. WHALEN:  Please go ahead.

    MS. GODOY:  Yes, my name is Julie Godoy.  I am a U.S. citizen, married to a Norwegian, living in Norway.  I paid my own expenses.  I am not a professional speaker.

    DR. WHALEN:  Ma'am, and for everyone, the microphones are very directional.  So, if everybody, when they come up, would just make sure that they are speaking directly into the mike, it would help us.

    MS. GODOY:  Shall I repeat?

    DR. WHALEN:  You can just continue; that is fine.

    MS. GODOY:  Someone is going to read by speech, Jama Rosanna.  I am having some eye problems.

    MS. ROSANNA:  This is Julie Godoy.  She is a citizen, married to a Norwegian, currently living in Norway.  She is a breast cancer patient, implanted with silicone breast implants in 1980.  Immediately following her surgery, she suffered from an adverse reaction from the implants.  Monday morning, on CBS the President of the American Plastic Surgeons Society stated that the implant seeking approval has been used in Europe for ten years.  Tuesday, we were told that the implant has been used for 25 years in the U.S.A.  Obviously they are speaking about the old implants.  What is new?

    Europe has united their efforts to protecting their citizens against adverse and debilitated effects of failed breast prostheses on their women and children.  I flew here to see what new developments are pending with regards to the implant problem, only to find that there is no new device.

    There is nothing more than a facade--the same device, old product, new name.  I am having difficulty reading, sorry.  Recently, Inamed Mentor and McGhan breast implant manufacturers submitted new patents on breast implants, outer breast prostheses, shells and breast implant fillers.  In their own words, each patent identifies the failure of the design of the silicone sacs, migration of silicone oil outside of the implant and the toxicity of the silicone oil to human tissue, along with the medical literature documenting the failure of the prior devices.  In fact, all 73 breast implants from 1958 to 2003 have identified in great detail, with medical documentation, the adverse severe problems.  All previous breast implant patents document the high failure rate.

    For an example, in 1995 the Payman second breast Implant patent claimed that the Avalon breast prosthesis was porous so that it would absorb blood and other body fluids and become invaded by blood vessels and living body tissue, with the result that a sponge implant surrounding the body tissue became so interwoven as to permanently retain the position in the body.  Also, because of the infiltration of germs directly into the sponge, the fibers became more absorbent.

    Dr. Frank Gerro, in 1987, wrote in detail, severe adverse reactions to silicone breast implants identified human adjuvant disease comparing a ruptured implant to free silicone injections.  Additionally, escape of the silicone gel from the envelope of the prosthesis is associated with other adverse consequences in satelliting of the gel into various parts of the soft tissue around the prosthesis pocket down or into the arm.

    Recent data also suggests that the risk of infection in the surrounding prosthesis is increased following its rupture and free silicone gel in the prosthetic pocket.  He was the first to also identify death from a breast implant.

    In 2001, McGhan Medical Corporation filed for a patent for a filler material for a surgically implanted prosthesis such as breast implants--

    DR. WHALEN:  You need to draw to a conclusion, please.

    MS. ROSANNA:  --whiiich have conventionally used silicone gel.  Moreover, adverse consequences have recently become associated with silicone implants because it has been discovered that the silicone oil can migrate through the implant shell, and silicone oil is not biocompatible with the other human tissue.  Therefore, the use of silicone-based filler materials have been discontinued in the industry.  Those are their words.

    Dr. David Kessler discovered the addictive--

    DR. WHALEN:  Excuse me, you will need to end your comments, please.  You are over time.

    MS. ROSANNA:  Well, can I just finish the sentence?

    DR. WHALEN:  The very last sentence.

    MS. ROSANNA:  Dr. David Kessler found in the patents the addictive tobacco through the manufacturers' patents.  To date, we need to know what implant we are dealing with.

    DR. WHALEN:  I just need to reemphasize to everybody, in view of the first few speakers, we very much want to hear everybody who signed up.  Over the two days, we have about 110 such individuals.  The only way we can do that within the time constraints that I think have generously been set up for the public testimony, is to have everybody fulfill the time requirements that have been set for them.  So, please, if we could do so?  Thank you.

    MS. FEUSTEL  Good morning.  I am Holly Feustel.  I am receiving no compensation for speaking here today.

    Just over two years ago I had both of my breasts removed during simple mastectomies.  While the initial surgery and reconstruction were terrifying, the process was not new to me.  At the time of my surgery, two of my older sisters had already had the procedure.  Unfortunately, my family is intimately familiar with breast cancer.  The disease has taken my maternal grandmother, my mother, her sister and my cousin.

    While I have spent the majority of my childhood watching women die of breast cancer, my mother's and cousin's death have had the greatest impact on me.  I spent years of my childhood watching my mother experience the slow, painful death of fighting breast cancer.  When she died she was just 42 years old and I was nine.  I spent a year of my adult life watching my cousin and her battle with breast cancer.  At the time of her death she was just 36 years old and I had turned 21.

    You may be thinking that while my experiences are tragic, how are they relevant to you?  Well, my experiences are relevant because they are about choice.  At the time I had my mastectomies I was not diagnosed with breast cancer.  It was an elective surgery, my choice as the result of watching others die of breast cancer and discovering that my two older sisters and I possess the genetic mutation BRCA1.

    When faced with the results of my genetic testing, I chose to have a mastectomy.  I chose to have reconstruction following and I chose silicone breast implants.  I assure you that a lot of thought went into each of these decisions.  Perhaps the toughest choice was silicone versus saline implants.  Fortunately, when the time came to make that choice I had a wonderful plastic surgeon, years of sound research and the personal experience gained from two older sisters who already had the procedure.  One chose saline implants and the other chose silicone.

    I firmly believe that choosing silicone implants was the right decision for me.  I have no medical problems from my implants and I am pleased with the natural feel and shape of my breasts.

    I have come here today at great personal expense.  My husband serves our country in the U.S. Army and is currently away.  I have four school age children and I have traveled a great distance to be here for just three minutes.  My motivations are simple and selfless.  I want other women and my four young daughters to have the same options and choices that I had, and I thank you for your time.

    DR. ZOOK:  Good morning.  I am Elvin Zook.  I have been Professor of Surgery and Chairman of Plastic Surgery at Southern Illinois University School of Medicine for the past 30 years.  I am board-certified in plastic surgery.  I have no affiliations or conflicts of interest with the implant device manufacturers, and I have paid my own travel expenses to present at this hearing.

    In my practice of plastic surgery, I use breast implants in performing both breast reconstruction and breast augmentation surgery, and I derive a portion of my income from this type of surgery.

    Prior to the 1992 decision by the FDA, I actively used silicone gel breast implants for cosmetic augmentation of the breast, and since then I have used them for breast reconstruction, as permitted by the FDA under clinical studies.

    One of the sharpest criticisms leveled at surgeons during the 1991 and 1992 FDA hearings, and still today, is the perceived lack of adequate information given to the women before surgery regarding the safety of silicone gel breast implants.

    When using silicone gel breast implants in my own practice, I make every effort to inform patients about what is known about the safety of the implants, as well as the risks of potential complications that could occur.  I have found it is helpful to have sample implants available for women to see and feel during their consultation.  I believe this effort has been responsible for my not being threatened with any breast-related lawsuits.  I personally think patients should be educated as fully as possible on surgical procedures and materials.  They can then be free to make their own choice for surgery.

    Nearly one year ago I was asked by the American Society of Plastic Surgeons to chair a team to develop a patient information document to provide women with information on the risks and potential complications of silicone gel breast implant surgery.  A number of patient information documents were studied before we created this document.

    The group worked diligently to create what is now an online brochure, which you have, covering what is known about silicone gel breast implants, expectations of breast implant surgery, risks and potential complications.  Options for surgical placement of the implant are explained, as well as financial issues related to treatment of complications.

    The brochure includes color patient photos to visually illustrate some local complications.  It is followed by a series of questions to evaluate understanding of the effectiveness of the information and its validation.  We have tried to be comprehensive in our approach, recognizing that no procedure is totally without risk.  In fact, we all could agree that nothing in life is totally without risk.

    We believe that women who read and understand this information and ask questions should be adequately educated to make their own choice.  The brochure is available on the website of the American Society of Plastic Surgeons.  It is available to members of the American Society of Plastic Surgeons with the recommendation that they use it to inform women about breast implant surgery.  Thank you.

    MS. RAHN:  Good morning.  My name is Ruby Rahn.  I received breast implants after being diagnosed with fibrocystic and micromastia disease.  I have a similar story to many women who have made statements here.  I got breast implants.  After ten years I got very sick and once my implants were removed my health improved.  When I got sick I wanted to find out what happened to me.  I wanted to take responsibility for my health so it seemed reasonable to start to look for answers.

    I have spent the last decade trying to find answers.  In my search I came across an advertisement for silicone in an issue of Plastic and Reconstructive Surgery in which they talked about the wonders of silicone products.  It showed pictures of breast implants and other medical devices made of silicone, and I wondered if other products had problems too and I discovered they do.

    Wear debris is a well-known and documented complication of a long list of medical devices, including breast implants.  Wear debris occurs when implants age and degrade inside the body.  As implants degrade they start to break down into small particles.  They can travel to the lymphatic and vascular system into regional and distant parts of the body.

    To illustrate wear debris, I have included some photographs of breast implants that were removed from a friend of mine.  One implant is still intact, while the other shell has broken down and disintegrated.  These breast implants were removed en bloc where the implant and capsules were removed in one piece.  While the scar capsules held much of the silicone gel inside the elastomer, the elastomer shell broke down inside the capsules and is no longer visible.  What happened to it?  Where did it go?  And, what are the long-term effects of having an elastomer shell break down and migrate inside the body?

    When our immune system detects these particles, it responds by creating a chronic inflammatory foreign body reaction.  A similar foreign body reaction can occur when a splinter gets in your hand or foot, only in this case the inflammation isn't visible on the outside of your skin; the process happens internally.  Compound this reaction by having multiple implants over the period of 10 or 20 years and there is no question that you will develop a chronic inflammatory syndrome from countless splinter-like shell particles or wear debris.

    It is important to note that once the immune system becomes chronically activated, it leads to an ever-increasing attempt to destroy a foreign object that cannot be destroyed by the weapons our immunity has in its arsenal.  Our immune system is designed for destroying biological entities, not indigestible, man-made chemical composites like silicone elastomer.  In an attempt and failure to destroy these particles, our immune system chronically activates macrophages that produce destructive cytokines.  Cytokines and the chemical cascade they produce are implicated in a long list of serious health concerns, including depression, and may be the leading reason why so many women who have had breast implants have committed suicide.

    I strongly urge this committee to recommend to the Food and Drug Administration to further require long-term studies to investigate whether a cellular response to particulate debris is causing the health problems that hundreds of thousands of women, who have already had breast implants, are currently experiencing.  I think those are important questions to ask and understand before making breast implants available.

    Thank you for giving me this opportunity to make a statement.

    DR. WHALEN:  Ma'am, before you leave the podium, are you also going to be reading a subsequent statement?

    MS. RAHN:  Yes, I am.

    DR. WHALEN:  Do you have that with you now?

    MS. RAHN:  No.

    DR. WHALEN:  Okay, fine.

    MS. RUDICK:  Good morning.  My name is Nicole Rudick, and I am reading testimony for Donna Sims because she was too sick to be here today.

    My life with and without silicone breast implants: I am a 47-year old woman with no conflicts of interest.  I had silicone breast implants put in, in 1983.  In 1998, 15 years after implantation, I felt that my breasts were getting hard and painful so I had a mammogram done both in 1999 and 2001.  Both mammograms indicated very dense, fibroglandular breast tissue present.  The mammograms were so painful, they hurt so bad that if my breasts weren't stuck in the machine I would have been on my knees.

    I knew then that there was something really wrong with my implants, and I tried in every way I know how to find someone who believed me.  Finally, I found a plastic surgeon who is very reputable and took my problem seriously.  My plastic surgeon said that I had capsular contracture, grade IV, and I needed to get my implants removed as soon as possible.

    This is where the real problem starts.  My husband and I live on a low fixed income and I have no insurance.  We tried everything to get the money together for my surgery.  Finally my family came through with the money I needed for explantation.

    The surgery was scheduled for New Year's Eve, 2001.  The surgery was very painful and I was slow to heal.  The surgeon said that both implants were completely ruptured.  I had drains in for over a week.

    In October, 2002, ten months after explantation, I found two lumps in my left breast.  They were very painful and growing larger every week.  Again, I had to try to find the money before yet another surgery and, again, my family had to come up with the money to pay for my surgery.

    I had surgery in October, 2002.  The hard lumps turned out to be left over silicone from my explant surgery that had migrated throughout my breast.  Since then I have found two more lumps on my right side.  I can't afford another surgery.  I don't have any insurance and my husband and I are so far in debt I don't think we will ever see the daylight again.

    With my having silicone breast implants, I have not been able to find an insurance company that will insure me because of my implants.  I have tried to get help from my state government welfare program but I have been turned down several times because my husband and I own our own home.

    My hair has been falling out.  I have skin problems, dental problems and vision problems.  My entire body aches with pain and inflammation of my joints and muscles.  My memory is awful.  I have been diagnosed with fibromyalgia, polyarthritis, Sjogren's syndrome and silica.  I just don't know what is next.  The bills for all these tests just keep climbing and so do the illnesses.  Will this ever end?

    DR. BECKER:  Good morning.  My name is Dr. Karn Becker.  I am the president of a scientific consulting firm here, in Washington.  I have 15 years of experience in the development and clinical evaluation of innovative medical devices.  I have not been compensated for my professional time or expenses today.

    I came here because I was, as a woman and a scientist, alarmed at the misinformation being put forward in the popular press regarding these devices.

    Over the years I have contributed to the design and approval of many original PMAs and, in 1991, I prepared one of the breast implant PMAs considered by this committee.  My knowledge of the science and clinical experience with breast implants is extensive.  I have spent approximately 20 percent of my professional time over the last 13 years on one breast implant project or another.  As a result, I have personally reviewed thousands of studies--chemistry, manufacturing, preclinical, clinical and epidemiology.

    The past decade of research on this device has been productive and has considerably narrowed the focus of our questions regarding the performance or silicone gel-filled breast implants for reconstruction and augmentation.  Clearly, the product can be reliably and consistently manufactured.  The materials of which this device is comprised are biocompatible.  The short-term complication rates at two and three years have been reliably estimated.      The concern that these devices may pose a risk of long-term systemic toxicity or reproductive toxicity has been resolved by affirmative evidence from numerous well-controlled studies.  This data and information comprises valid scientific evidence sufficient to provide a reasonable assurance of safety and effectiveness for this device when marketed with adequate instructions for use.

    The premarketing clinical data provided in this application you are considering today, with three-year follow-up, is more extensive than that typically required for an implanted device.

    The data on the long-term performance of this device is, however, limited.  Premarketing studies do not provide data on rare or uncommon complications, nor on the long-term performance of implanted devices.  This committee is aware that questions of long-term performance are evaluated in the postmarketing setting.  Postmarketing studies for innovative implanted devices, although not required, provide the opportunity to study the performance of the device in a broader patient population, in larger numbers of patients, and over a longer period of time.  This information is essential for continued safe use and for continued product improvement.  For the silicone gel-filled breast implants under consideration today, the sponsor has proposed postmarketing research to assess long-term performance.

    I respectfully submit that this committee consider the approval of this product be accompanied by a risk management program to include three elements, number one, a mandatory informed consent; number two, a postmarketing study to provide clinical data on long-term performance, in particular, the incidence and prevalence of complications and device failure over time.

    DR. WHALEN:  Conclude, please, doctor.

    DR. BECKER:  And, third, a device retrieval program to study the changes that occur in the product itself over time, and systematically investigate the failure modes for this device.  Thank you for the opportunity to comment.

    PROF. DUBLER:  Dr. Whalen, may I pose a question for a moment?

    DR. WHALEN:  Yes, Prof. Dubler?

    PROF. DUBLER:  We have heard that there is a new application and new patents that have been submitted by the sponsor.  In your work, have you worked on these patent applications?

    DR. BECKER:  I have worked on some but I don't know the ones that you are referring to, not for this sponsor.

    PROF. DUBLER:  We have been told by the sponsor that the product under consideration by this panel is precisely the same product that was discussed in '91 and '92.  But there is also the implication that a new product is being developed.  Have you worked on this new product?

    DR. BECKER:  With this particular PMA, I am only familiar with the publicly available information.  So, I couldn't say, myself, whether it is exactly the same as the submission made in 1991.

    PROF. DUBLER:  Thank you.

    MS. RAHN:  My name is Ruby Rahn and I am reading for Lale Goddard, who is too sick to be here today.

    My name is Lale Goddard and I have no financial ties with anyone.

    In 1997, my breasts were augmented with silicone gel-filled breast implants.  In the mid-1980s, I started having joint pains and depression with thoughts of suicide.  I was diagnosed with bipolar disorder.

    In 1987, my rheumatologist diagnosed me with definite asymmetrical inflammatory arthritis or possible rheumatoid arthritis with atypical presentation, with poly arthralgia but with little joint swelling.  My bone scans showed signs of inflammation and my bilateral hand and wrist x-rays showed non-specific bone irregularities.

    In 1988, my bleeding sediment rate went up to 85 and X-rays of my hands and feet showed multiple bone erosions.  I was also diagnosed with fibromyalgia, anemia and seropositive rheumatoid arthritis.

    In 1989 I had my breast implants removed and both implants had ruptured and the elastomer shells had deteriorated, and my left breast was deformed.  I have joint contractures, ligament ruptures and severe osteoporosis and my right hand is deformed.

    Silicone elastomer used in solid or bulk form is biocompatible.  However, transformation of silicone elastomer of an intact silicone gel-filled breast implant, into particulate debris and the capacity of the particles to induce excessive inflammatory cytokine synthesis by macrophages and other cells, could cause particle-activated arthritis that mimics rheumatoid arthritis.  Unlike silicones, inflammatory and anti-inflammatory cytokines are biologically active proteins.

    Orthopedic surgeons refer to bone destruction due to macrophage activation by particles as a cellular response or particle disease.  They do not refer to it as immune response or autoimmune disease.  Scientific literature states that elevated inflammatory cytokines can contribute to the induction of depression and depression can lead to suicide.

    The FDA has recognized, in vivo and in vitro, testing standards of biological responses to particles and both standards state the following:  It is well recognized that the biological responses to particles could be different from those to solid materials.  The interaction of the particles with cells in the tissue, notably macrophages and other phagocytic cells, is the key to the final biological response.

    Please recommend to the FDA to require Inamed Corporation to do preclinical testing for biological responses to elastomer particles, less than 10 microns in size, prior to the approval of the PMA because it is relevant to women's health.

    If you have any questions, call me anytime at area code 916.444.1967 or send me an e-mail at lalegoddard@msn.com.  For a copy of my statement, go to my website at www.lalegoddard.com.  Thank you very much for your time.

    MS. CLARE:  Hello, my name is Erica Clare.  I am reading for Teresa Hamilton, who is too ill to be here today.

    My name is Teresa Hamilton, and I am from California.  I have no conflicts of interest.

    In 1986 I was diagnosed with breast cancer at the age of 29.  My left breast was removed because of cancer, and a month later my right breast was removed since I was told I had a one in three chance of getting cancer in that breast prior to menopause.

    After radiation treatments, I had expanders put in to stretch my skin out so I could have implants.  These were removed and temporary implants were put in a few months later, in 1987.  I still had problems with scar tissue so stronger implants, made by McGhan, now Inamed, were used to replace the other implants.  I looked and felt great for maybe two years.

    After that, I started to get allergies to nickel in jewelry and allergies to pollen and penicillin.  I also had repeated yeast infections and seemed to get more and more colds.  Being a single parent, it was getting harder to take care of my elementary school-aged daughter.  She would have to stay at my parents' house while I would try to recuperate.

    A few years later I noticed my right implant was getting harder.  The infections and allergies seemed to get worse.  Soon I was housebound and stayed that way for over five years.  Still, I was told my implants were safe.  By this time, my daughter was living with my parents most of the time since I was too sick to care for her.

    In 1999 I thought I had better have my implants removed.  The left implant was weak but still intact.  The right implant had dissolved completely, shell and all, into a gooey mess.

    I have since had a hysterectomy due to numerous fibroid tumors.  I now have a lowered immune system, fibromyalgia, a low thyroid.  I am constantly tired despite medication to help my fatigue, asthma, and foggy thinking.  I am 45 years old now.  I am slowly detoxing but I am still so ill I can't work except when I feel up to it, just a few hours a week.  Consequently, my parents, who are in their 70s, are having to take care of me and pay for most of my medication bills and all of my living expenses.

    I was in the Dow Corning settlement but I have only seen $725 for years of pain and suffering.  My chest is scarred and disfigured as a result of all the surgeries I had to have to put in the implants in the first place.  I don't believe that I will ever get the justice I deserve from all the pain, suffering and expenses that implants have caused me and my family.

    I have been cancer free for over 14 years now but I am still chronically ill from my silicone/saline implants and the right one rupturing and dissolving into my body.  I never had any of these health problems before having breast implants, but I am sure that having these implants has not only lowered my immune system but will also lower my life expectancy as well.  After all, they have been slowly killing me for years.  Thanks for letting me speak my mind, Teresa Hamilton.

    MS. ROBINSON:  Good morning, ladies and gentlemen.  My name is Cheryl Robinson and I live in the Damascus, Maryland area.  Due to the enormity of this issue and the fact that the safety and quality of women's lives are at stake, I am obligated and compelled to share my story.

    I have no financial relationships with Inamed or any other of its competitors.  My decision to choose silicone augmentation was cosmetically motivated.  Initially I was very happy with my decision.  My breast implants enhanced my self-esteem and promoted my confidence.

    It wasn't until ten years after implantation when I began to suffer with complications.  I noticed that my right breast began to harden, exhibiting signs of capsular contracture.  I also began to notice my left breast was getting smaller.  I now realize that was an early indication that my implants were leaking silicone from my chest into my bloodstream and tissues.

    Over the years I became very ill, presenting with a host of physical and neurological symptoms, for example, the inability to concentrate; profound confusion; and short-term memory impairment.  Eventually it became impossible to resume my family responsibilities and I was unable to support our lifestyle, and had only my husband's salary and mounting medical bills.  Keep in mind that before all of these symptoms surfaced I was very physically active; actually one of the few female jockeys in my early 20s and continuing to maintain my active lifestyle through middle age.

    When I was explanted both implants were found to be ruptured and had probably been so for a long time, though there is no way to predict exactly when the ruptures occurred.  My implants were considerably lighter than when originally implanted and the silicone that couldn't be removed during my en bloc procedure is still migrating throughout my body.

    I have been diagnosed with fibromyalgia, chronic fatigue, Hashimoto's thyroiditis and autoimmune related thyroid disease, and degenerative disc disease.  At the age of 49, I am left with the fears and uncertainties of what diseases or conditions may continue to surface.  For me, there is no doubt had I not made the decision to be explanted, I would not be personally delivering this short speech to you today.  I am absolutely, unequivocally sure that my implants were the direct cause of my declining health.  Of course, I suffer with depression as I live my life in chronic pain and am forced to accept the fact that there is no proven or definitive way to rid my body of the silicone that has migrated from my chest, ravaging and polluting my body on a systemic level.

    The data being presented on behalf of Inamed to market silicone breast implants does not reflect the long-term studies that are necessary to assess the possible safety and health risks that these implants may impose.  Silicone breast implants do not offer women a choice but, rather, offer women a chance to play Russian roulette with their health.

    I respectfully ask you, members of the panel, would you allow or encourage your loved one to be the recipient of such a ticking time bomb?  I hope the answer to this question is a resounding no.  Thank you for your time and attention.

    MS. DONNY:  My name is Stephanie Donny.  I am reading for Linda Dintino, who is too ill to be here this morning.

    My name is Linda Dintino.  I had one set of silicone breast implants, implanted in 1980, at the age of 27, when my breasts were removed due to fibrocystic disease.  Silicone breast implants were in my body for 13 years, until I was explanted in 1994.

    Within two months of implantation I developed migraine headaches.  Every day of my life for the last 23 years I wake with a headache that does not go away.  I was a healthy woman in 1980.  I had two beautiful, healthy children without any problems.  I was athletic even after implantation.  I was a very active mother of two boys, a Cub Scout leader and a secretary of the PTA.

    In 1987 I was forced to give these activities up, along with enjoying my children growing up.  You see, I was just too tired and hurt too badly to do these activities any longer.  I could not lift my arms above my head, the pain was too great, and I had slowly been losing upper body strength for years.  I literally had to sleep with pillows tucked in between my breasts while sleeping on my side because of the burning hot pain involved.

    When the implants were removed from my body, I learned that my right implant was ruptured.  I was left with a big gaping hole in my right chest wall.  My body would not heal properly.  I walked around with this hole in my chest for four months.  My scars were open on both sides and would not close.  Even the drainage holes where the drainage tubes were took longer than they should have to heal.  I dressed these holes in my body twice daily for four months, while green oozing slime came from them.

    I am only one woman in a sea of thousands, all experiencing the same problems, and the only common denominator between us is the fact that we all had silicone breast implants.

    Studies that are being touted as proving that implants are safe have been bought and paid for by the very manufacturers that produce them.  These manufacturers are not studying what we have going on in our bodies, the very women that were affected.

    We need real research.  We need for this panel to take a stand and demand that thorough research be done, not just a short-term study aimed at putting money in the pockets of the manufacturer.  Thank you.

    MS. SMITH-MILES:  Good morning.  My name is Becky.  I am from northern Michigan.  I have not been paid or reimbursed, nor have any conflicts of interest.

    I had silicone implants put in over ten years ago.  I developed capsular contracture within two years and had intense pain.  I wanted to be more beautiful with implants.  Instead, my breasts became scarred, hard and ugly.  I hid my breasts from my husband.  I could not jog, walk fast or jiggle my implants without experiencing intense pain.

    Within eight years I was diagnosed with a neurological disease.  I went from being a very athletic, active person to being physically inactive.  I was a registered nurse.  I worked daily prior to my implants.  I have had fatigue, aches, spasticity with numbness and tingling in my calves, toes and fingers.  My headaches are severe and every day.  I started to stumble while jogging.  With the intense pain and general ugliness of my breasts, I became depressed.

    A mammogram confirmed I had ruptured.  I don't know for how long.  My skin developed rashes and reactions to different substances.  I started to have blister-like eruptions on my fingers.  These were intensely painful, with burning and itching.  I would scratch, and scratch, and scratch until the top layer of my skin would come off.  Then I found that if I used my teeth and bit into them, I could feel a little crystal on my tongue.  As soon as I got that crystal out, it healed and it stopped burning and itching.

    My gynecologist noted my depression and he ordered the MRI which diagnosed me with an autoimmune neurological disease.  My implants and capsules were removed.  My histology has shown giant cell incursions around my capsule.  My blood work has tested positive three times for ANA.  I developed partial facial paralysis and extreme gait disturbances.  I have had silicone leakage in my chest, in my axillary lymph nodes and down my arms.

    For the last five years I have been having silicone eruptions surgically removed and they keep popping up all over.  My life since getting implants has changed totally and forever.

    I lost my job and became disabled.  I suffer periods of being bed-ridden for days.  I can no longer jog, ski, exercise or even walk without the assistance of a cane.  I can't help my son's soccer team or his football team.  I can't ride my horses any longer, which was one of my big passions.  I can't shop or go for a walk in the woods--that is totally out of the question, or even pick up my grandchildren.

    I have lost most of my friends and all of my social life activities.  I beg you to think about my limited life when you make this important decision.  Thank you for your time.

    MS. DOWD:  Good morning, members of the panel.  My name is Pam Dowd and I am reading the story of my friend, Myrl Jeffcoat, from Sacramento, California.

    Hello, my name is Myrl Jeffcoat, Sacramento, California.  My purpose for writing this statement is to tell this panel a little of my experiences regarding silicone gel breast implants.

    On December 7, 1994 I was implanted with MgGhan 3M silicone implants.  I was very pleased at that time with the cosmetic outcome.  But in mid-1998 I began experiencing health issues that were diagnosed and tested for, subsequently being put on propranolol, a beta blocker, for severe daily headaches, gait problems, extremely low blood pressure and heart rhythm problems.  I also had developed an involuntary head tremor.  Propranolol has been a wonder drug in containing many of these symptoms but not the daily headaches, which I continue having to this date.

    Later that year I developed thyroid problems and was put on thyroxine, and I was diagnosed with cervical uterine cancer and was given a hysterectomy in early in 1989.

    In the early '90s I began a severe bout with chronic fatigue and fibromyalgia.  My hair began falling out and became thin.  I still have fibromyalgia symptoms often and the persistent daily headaches.  On my visits and testing with my medical professionals during the late '80s and early '90s implants were never mentioned as being a suspected cause of my health issues.

    In '92 or '93 I read articles written about my health symptoms and illnesses being associated with breast implants.   The medical community simply doesn't want to go there with our illnesses with breast implant association.   They continue to this day to be in total denial of it.

    In about 1994 I was seen by Dr. Eric Gershwin, of the University of California at Davis, and he classified me as a category B on the old global settlement grid.  It has been approximately nine years now that myself and nearly 440,000 women in this country have been corralled in this travesty of justice, some of us having been paid pittances from what we were originally promised; others not being paid at all; and some that will never see a dime for the pain and suffering they have endured.

    Our medical bills, sent to the MDA, are being hidden in a shroud of secrecy while cloaked in an exemption of the Freedom of Information Act.  Yet, in all of that the silicone manufacturers continue to believe they can turn a profit selling these harmful products to the women of this country and other areas of the globe.

    For 40 years there has been no FDA approval of these products.  There has only been a long and endless trail of meaningless studies while manufacturers continue, with FDA's blessing, to put human life and health at risk.  The reason for my comment here is to implore the FDA to perform the job the American taxpayers pay them to do.  I request that they perform their own studies and tests on silicone implants and not rely on the biased studies of manufacturers who stand to gain financially while putting human beings at risk.  Thank you for your time.

    MS. DONNELLY:  Good morning.  My name is Kathleen Witter, and I am going to be reading testimony from Elaine Donnelly, who is too ill to be here.  She has no financial interest in Inamed, nor any other competitors, nor is being paid to submit her testimony.

    My name is Elaine Donnelly.  I am 44 years of age, and I reside in Louisiana.

    I was augmented with silicone gel implants at the age of 19.  I was a healthy young woman who worked effortlessly as a health and exercise counselor and attended a local university.  I loved the look and feel of my implants and I felt, although expensive for me especially on a college student's budget, it was something I deserved and that I had earned.

    After my implantation I began to experience capsular contraction.  I returned to my plastic surgeon and a revision was performed.  Again within a few months, capsular contraction occurred but I didn't have any health problems.

    Nine years later I began having severe health problems that my doctors could not diagnose.  They believed that I had some sort of autoimmune disease developing.  I spent a total of 27 months in the hospital over five years, having tests performed and repeated, yet no treatment or cure could relieve the symptoms I was experiencing.

    In February, 1994 I suspected my implants were leaking since my breasts looked noticeably smaller each day.  I was told to have a mammogram done to see if there were any abnormalities to my breasts.  That is when I found out that both of my implants had ruptured.

    One week later I had my implants removed.  Much of the gel was gone from each breast implant and cannot be retrieved from my chest cavity.  Any breast tissue that was contaminated with the sticky, unstable gel had to be removed surgically.  As a result, I lost all my breast tissue in both breasts.

    My breasts are now deformed in appearance, and I am not among those who are fortunate to have had their health restored after explantation.  Perhaps because of all the silicone in my body, my health has continued to spiral out of control and I have become homebound.  Many days I am to ill to even get out of bed.

    As a result of having been augmented with silicone gel breast implants, my health has been destroyed and my body has been deformed.  It is imperative that breast implants be studied at least a decade, not only a few years.  Most women who might have problems will not begin to show their problems for at least seven to ten years.

    In addition, since some women who might have problems will not be able to obtain health care through the private health care industry because many health insurers will not cover a woman with implants even if she is in fine health, they might become dependent on Medicaid and Medicare programs.  That is why our government has successfully sued several breast implant manufacturers for tens of millions of dollars to reimburse Medicare for the cost of care of women who became ill because of their breast implants.

    I implore you to vote against the request made by Inamed to approve their silicone breast implant based on such a short research study.  In addition, I have much faith that some day you will have safe implants and I look forward to that day.  If we can put a man on the moon, we can put out a safe implant and women deserve that choice, but we will only have a safe implant once that implant has been studied thoroughly and researched for at least ten years.  Thank you so much for your time.

    MS. HANSON:  Good morning.  My name is Georgiana Hanson and I am reading for Rogene Schorer, who can't be here today because she is too ill.

    My health took a downturn within weeks of getting silicone gel breast implants, beginning with chemical sensitivity.  It wasn't until 15 years later that I realized that my implants might have anything to do with my scleroderma, my fibromyalgia and my cognitive problems.

    Ten years after having my implants removed, most of my health problems have been reversed and, as long as I am mindful and follow a fairly strict health program, I feel well.

    I have been an activist in the implant issue from the time I attended my first support meeting.  It was there that I watched a group of young mothers learn for the first time that the health problems their children were experiencing were shared by the children of other implanted women.  That awful moment, seeing the shock, guilt and horror on the faces of those young mothers, has been my driving force since then.

    After all these years, I ask why is there still no definitive study on the effects of breast implants on unborn and nursing children.  Over the years I have communicated with thousands of women looking for information and support.  One thing we all have in common is a pattern of symptoms that are destroying our lives.  These women are from all walks of life.  They could be your daughters, your sisters, wives and mothers, maybe even your sweet little granddaughter some day.

    The women are often desperate.  Some see suicide as the only solution.  They are sick but don't understand why.  They feel, as I did, that they are dying without knowing why.  They are frequently in pain, experiencing cognitive problems, mood swings, allergies, digestive problems and neurological problems but the doctors can seldom define their illnesses.  Many doctors, especially their implanting surgeons, have been rude and dismissive.

    In the meantime, women often lose their jobs, medical insurance, savings, and sometimes their home and family.  Many of them end up struggling to survive on welfare and Medicaid.  Of course, those numbers will increase if silicone gel implants are approved.

    The marking of breast implants usually targets young women, often before they have children, before they are mature enough to understand how much their decision could cost over their lifetime.  The costs are not only in dollars, but in health, careers, insurance and relationships.

    Few women will visit the FDA's very informative website to learn about the risks before getting breast implants.  This company has not proven that silicone gel implants are safe, and so they should not be approved.  However, if women are allowed to use them as part of clinical trials, as has been the case for ten years, a third party should counsel them on all aspects of the study.

    In closing, each new generation of implants promises to be new and improved but, to date, all have failed to be safe in the long term.  There is a huge population of women who have already received breast implants.  Before subjecting more women to studies for new and improved implants, we need to study what has happened to those who already have them.  This disaster has been going on too long.  Do you have the fortitude to stop it?  Thank you.

    DR. WHALEN:  As the next speaker is coming up, just so everybody knows, each individual speaker has three minutes.  People who speak for organizations have greater periods of time.  For anybody who has yet to speak who is anticipating that they will have more than that amount of time--that will be only if somebody else has yielded time to you.  So, if you come up and you have more than three minutes, you could perhaps just tell us whose time has been yielded to you to allow you that extra amount of time.  Thank you.

    MS. GOLDRICH:  Good morning.  My name is Sibyl Goldrich and I am speaking on behalf of Wanda Simison, who is too ill to attend.

    I was diagnosed with a precancerous tumor in 1987 and, after a mastectomy, I used McGhan, now Inamed, gel implants.

    I developed aches and pains, eye problems and a general feeling of unwellness within two years, and was diagnosed with fibromyalgia in 1992.

    I saw over 60 medical doctors in North Carolina, Florida, Texas, Connecticut and New Jersey who could not give me a definite diagnosis for my illness.

    I became blind in my left eye and my health rapidly deteriorated.  I have been bedridden with dozens of symptoms since June of 1993.  I have been diagnosed with MS and lupus.  I was hospitalized for ten days at St. Mary's Hospital, in Connecticut, where they found lesions on brain and spinal cord, and an ANA of 180.

    I was then transferred to a different hospital where I spent another 53 days getting stabilized and prepared for explantation.  My implants were removed in 1993, and the right implant was leaking.  I was hospitalized for a total of 180 days within a one-year period due to illness and toxicity from breast implants.  I was explanted on my birthday, September 22, 1993, and felt better within 24 hours.

    I spent $300,000 on treatments not covered by insurance, and relocation to Houston, Texas for 18 months.  Gradually my health has improved and most of my blood work is back to normal.  I have not developed new lesions on brain or spinal cord.  My brain fog improved greatly after explantation, but depression is still a huge factor.  I can't handle stress of any kind; my diagnosis of fibromyalgia was taken away.

    It is the FDA's job to approve medical implants that are safe and effective.  I understand that cancer patients need some form of reconstruction, but it should be safe, not almost safe.

    Meanwhile, the United States Department of Health and Human Services is suing breast implant manufacturers for Medicare costs of ill breast implanted women.  Where is the logic?  What information that the company provided would convince that breast implants are now safe?

    Wanda has asked that I take the remaining time that she has.  Last night there were a few questions that came up about gel migration and I would like to read to you from the panel memorandum, page 37:  Cases of distant migration of gel to breast axillary lymph nodes, abdomen, groin, arms and fingers have been reported, some with serious consequences and deformities, for example, extensive migratory granuloma, formation of contracture, and scarring from gel extrusion and ulcerations described as a result of gel migration.

    Inamed also reported on the results of a physician survey in which five cases of migration were reported out of 114.  I just wanted to point out the location of that to you.

    I also wanted to mention to you that this is really a matter of common sense.  We are asking for ten years of study.  Breast implants are available.  Women can get them.  Nobody is being denied the product.  But we are being denied the appropriate studies to prove that this product is safe.  I implore you to give us the ten years.  This company will survive.  They are selling their implants.  Please, ten years of study.  Thank you.

    MS. ERICKSON:  Good morning.  My name is Jan Erickson.  I have been asked to present the testimony of Lois Travis, who is not able to be with us today.  Lois lives in Houston, Texas.

    Her testimony reads, I was happily married and the mother of two beautiful girls, working part-time in the hospital as a registered nurse.  After mastectomies in 1965 and 1971, I was encouraged to have reconstruction surgery will silicone implants.

    Four months after implantation I began having vision problems and was told that I had cerebral edema, cause unknown.  My physical strength and endurance declined and I could not continue my active lifestyle of cross-country skiing, mountain hiking and tennis because of muscle problems.  I did try to play tennis but it was difficult because of muscles cramping up and shortness of breath, and I would have to stop the game to catch my breath.

    In 1976, a rheumatoid workup was done and the results mentioned possible early connective tissue disease.  I lost half my hair and was told I would possibly have to wear a wig.  I also lost some of my smaller nails and my entire body peeled.  To this day, I have very thin hair.

    The implants were changing and I would notice slight differences in the shape and then tightening around them that started to cause limitations in my reach and range of motion in my arms.  If I reached too high it was a sharp, burning pain and if I lifted something, like patients, it was sore for days.  The contractures around the implants became very hard, painful, asymmetrical and distressing to me, especially when trying to choose clothing.

    In 1987, because of the pain and limitations, I sought medical advice and was told I needed to have the implants removed and replaced.  I foolishly agreed to be re-implanted with double-lumen implants.  After surgery, I was told that the ones that were removed were taken out in pieces because they had ruptured.

    I later suffered suicidal thoughts and was hospitalized.  I was dysfunctional, mentally dull, unable to care for my business affairs and unable to read and comprehend what I had read.  I still have difficulty following instructions, reading and writing my thoughts.

    In 1994, I was explanted after seeing a rheumatologist.  If I had known the damage silicone would cause to my body I would never have agreed to have the first ones put in, let alone the second ones.

    I am somewhat better since my second explant but I am still plagued with muscle pains, headaches, depression, burning pain in my hands and feet, stabbing pains in the deep muscles of my legs, arms and hips and last, but very important, severe chemical sensitivity.  If I start to enter an elevator and it has just been cleaned it triggers my asthma.  Strong odors and most perfumes will trigger an asthma attack.  I must have my inhaler with me at all times.

    Now I know that there was not sufficient research done to back the claims of safety of silicone breast implants, and the new Inamed research shows that there is still not enough research to prove that they are safe for the long term.  I hope my story helps you understand what those statistics mean; what it is like to live with breast pain and pain throughout your entire body; what it is like to have your quality of life decline year after year.

    Thank you for your attention, and I hope you will give great thought to our testimonies before you allow other women to possibly be burdened with this kind of history.  It is no fun.

    Additionally, I would like to--

    DR. WHALEN:  You need to conclude.

    MS. ERICKSON:  Excuse me?

    DR. WHALEN:  You need to conclude, please.

    MS. ERICKSON:  All right.  I am also handing a letter over to the members of the panel that is co-signed by a number of national organizations.

    MS. COOK:  My name is Jennifer Cook and I am here on behalf of Deborah Guillory.

    My name is Deborah Guillory and I had silicone gel implants inserted into my body at the age of 19.  I was fine at first, but years later I could no longer walk a straight line and my concentration and memory were very impaired.  I also suffered from fibromyalgia-type pain.

    I had the implants removed in March of 1992, and at that time the left implant was only half the size of the right implant, half the size it had originally been.  This meant that a great deal of leakage had occurred over the 22-year period that I had my implants.

    I am glad to say that my ability to think and concentrate has improved after the implants were removed and I can now walk in a straight line.

    I have had to take antidepressants since 1992 because of low-grade depression, which is consistent with the three recently published studies of high levels of suicide among women with implants.  A forensics pathologist found that I have large levels of platinum in my body.  The pathologist explained that this platinum was contained in the silicone gel implants.  I still experience fibromyalgia-type pains, like the women in the FDA's study of leaking implants, and I have been disabled and unable to work in ten years.

    The silicone implants with the thicker gel were not expected to ever leak.  Current implants are made with thinner gel.  But perhaps most important, you can't tell what will happen to someone's health until at least ten years later.

    I am now going through a divorce, and attribute this largely to the fact that I am unable to lead a life of normal activity level and my husband would no longer tolerate this deficiency that I must live with.  Silicone gel implants ruined my life.  Sincerely, Deborah Guillory.

    MS. VOSS:  Good morning.  My name is Gerie and I am 29 years old.  I have come to address this panel today to explain why I believe the restrictions against silicone implants should be looked at based on my own positive experiences with them.

    I began my painful struggle with breast lumps and eventually breast cancer at the age of 20 after six years of having breast surgeries to remove these lumps, and fortunately learning they were benign fibroids.  I was not so lucky in the year 2001.  That year I learned that I had severe atypical hyperplasia in my left breast and ductal carcinoma in situ in my right breast.

    As a result, at the same time that I was planning my upcoming wedding for the following year, I was exploring medical options with breast surgeons, medical oncologists, radiation oncologists and plastic surgeons.  I eventually decided to have a  nipple-sparing bilateral mastectomy with immediate reconstruction, a decision that would change my life, and certainly for the better.

    During my recovery period I had several saline expander injections into my breast between October 2001, my initial surgery, and February, 2002, my follow-up cosmetic surgery.  I was surprised to see that the saline expanders were quite visible beneath my skin showing folds, creases and dimples.  My research explained, and my plastic surgeon confirmed that such an appearance was common using a saline-filled implant.

    When it came time to order my new implants for my follow-up cosmetic surgery I was a little nervous.  Like many women, I had heard that silicone breast implants may be harmful to my health.  However, upon further research I learned that there was actually no evidence that silicone implants were directly responsible for causing cancer occurrence.  I am so glad that I did that extra research and I was able to learn the truth about silicone implants.  It was a huge difference in my recovery process.

    In a couple of weeks after follow-up surgery I was back to work, cancer free and feeling better than I had before the surgery.  I took the liberty of taking a slightly bigger cup size and, with the help of my plastic surgeon, got two perfectly shaped breasts, much better than after my earlier surgical biopsies.  As a result, I was able to get married in the wedding gown of my choice; danced all night long and have a wonderful honeymoon, not ever wondering whether everyone thought that my breasts might not be real.

    I realize that not all women are as fortunate as I am to have caught my cancer so early; have active professional doctors and the freedom to carefully consider my treatment options.

    While I know that these options did not totally eliminate my risk for recurrence, it gives me the best possible chance to not ever have to worry again about those fibroids and hear the words "you have breast cancer" again.  It also did something else, it was extremely important to my overall recovery.  It helped me to restore the confidence that I had lost during the whole process.  I am proud of how I look again.

    Hopefully, not every woman will have to go through what I have gone through, but I strongly believe we need to allow women who want or need implants the choice to decide which is best for them.  While the appearance of the saline implants may be fine for some women, it is not fine for all women, especially those of us diagnosed with breast cancer in our 20s and 30s.

    Please let us make informed decisions as to what we want to do with our bodies.  Silicone implants were the right choice for me and they may be the right choice for other women like me.

    DR. HELMAN:  Good morning.  I am Susan Pope Helman.  I have no conflict of interest.

    As I speak, please pretend I am your wife or someone you love very much.  A little over 13 years ago I was normal.  I had two children and took care of my mother who had Alzheimer's disease.  I had two jobs and put myself through college.  I was a productive tax-paying mom who enjoyed golfing, swimming, bicycling and long walks on the beach and in the mountains.  I never missed a day of work.

    Then, September 6, 1990, I made the biggest mistake of my life.  I trusted my plastic surgeon who stated that silicone breast implants were safe and they would last me a lifetime and I would go to my grave with them.  I assumed the FDA had determined they were safe or they wouldn't be available.  Boy, how wrong that was!

    Within about six months I started getting horrible headaches.  I couldn't think right and noticed that I was dizzy and nauseated an awful lot of the time.  I would lose my balance and feel like I was going to fall over.  I couldn't figure out why.

    During the second year all of my hair fell out.  I was diagnosed with fibromyalgia.  I couldn't concentrate and I seemed to be in a fog most of the time.  When the pain would come I would thrash back and forth in bed and I couldn't see; I couldn't focus; I couldn't get up.  My life was destroyed.  I lost a wonderful job.  I lost my car, my salary, my home, my productivity and my sense of well being as a person.

    The illnesses began with a vengeance around 1997.  Both breasts burned like they were on fire and they throbbed with pain.  I had sores, blisters in my mouth and on my hands that would bleed, as well as on my bottom all of the time, and I wondered why I felt so bad and couldn't figure it out.

    I had the implants removed in 1992.  The implants were only in my body less than two years.  In 2001 I found out the reason.  The capsules which contained bacteria and T cells and silicone were still left inside my body and continued to make me sicker.

    I also found out both implants had ruptured and all of the silicone was never accounted for.  Testing revealed that silicone had migrated throughout my entire body.  I have had brain scans that show lesions.  I was told that I have the brain of an old lady.  Other tests showed other neurological problems.

    Two years ago a plastic surgeon removed the remaining capsules and the silicone that had spilled out into my chest.  She said she couldn't get it all and I had to live the rest of my life this way.

    I was treated like a guinea pig in a horrible experience that never should have been allowed to happen.  Without the grace of God and my husband, there is no way I could have made it through this.

    If the FDA approves these silicone gel implants, we know that women will be told that the FDA has decided that silicone breast implants are completely safe.  I really want this panel to seriously consider the experiences of women like me.  My hopes are that you will make it clear that a company that wants to sell breast implants needs to provide at least ten years of good data before expecting their implants to be sold and approved by the FDA.  Thank you.

    DR. ANDERSON:  May I ask the speaker a question?  Ma'am, a number of people like you have testified about the serious and terrible experience that you have had and then said we want ten years of data.  My question to you is if they came up with ten years of data that did not show a connection between the silicone implants and the illness that you are experiencing, would you accept it as being that, no, there really is no connection, or is your belief that there is no question that these two, regardless of the data, are connected?

    DR. HELMAN:  First of all, my belief is the guidelines for safety in any situation, and particularly for the FDA, are "do no harm."  My feelings are if they are proved safe beyond any reasonable doubt, then I believe they should be available.  Thank you.

    MR. HELMAN:  I don't have any problem pretending that I love her; she is a loved one.  She is my wife.  I am Craig Helman.  I am angry about all the things that she doesn't and does talk about, and have to take all the drugs that she takes with the hope of just staying alive.  I lay there at night, watching her in bed, jumping around, jerking uncontrollably with pain, and watch her face when she is grabbing her chest because she is in pain.  I have lived each day of this and enough of that.

    With all the modern technology, I think that the manufacturers could invent something that is safe.  It seems to me like, no matter what they do with silicone, it is still migrating through these people.  Maybe they will make a better wrapper and it can't get out.  I don't know what they have to do, but they need to do something.  Until silicone implants have been proven completely safe--I don't know what to say.  I would like to see more independent long-term studies before the FDA can make any decision.  That is it.

    DR. BATICH:  My name is Chris Batich.  I am a professor of material science and engineering, and also biomedical engineering in University of Florida.  In the past I have served as an expert witness for plaintiffs and defendants in the breast implant area.  I only work with plaintiff attorneys part time.

    The National Organization of Women has paid for my room last night.  I am up here for an NIH study section so they paid for my travel.

    I would also like to thank the panel for having such an inclusive meeting in covering this information, and I would also like to thank Mary McDonough for the three minutes that she has provided for me to expand to six minutes.

    DR. WHALEN:  Doctor, what was that name?  That yielded to you?

    DR. BATICH:  Mary McDonough.

    DR. WHALEN:  Just to clarify, I have taken the time off and you will have whatever time was allotted to you.  She has given you three minutes or her entire time since she was representing her organization.

    DR. BATICH:  My apologies for running through this very quickly.  Of course, there is not a lot of time for a technical presentation.

    [Slide]

    I am going to talk about the chemical composition, the uncertainties in that, and the changes in the chemical composition of the breast implants and what should be known about it.

    [Slide]

    If you are going to put something in someone's body that is going to continuously release material during its entire lifetime by gel bleed or, occasionally, by rupture as a bolus you want to know some things about it.

    First of all, what is being released?  This is highly variable.  It depends on manufacturing changes and it is frequently not documented.

    You would like to know how much is released.  This is highly variable, depending on the women.  For one thing, the type of surgery--it is not a well controlled parameter right now for both implant reasons and for physiological reasons and biological response.

    You would like to know where the material goes.  There are major uncertainties about where the material is distributed through the body, and some good radiolabeled studies would resolve a lot of these issues.  Some of them are starting to be done now.

    You would like to know whether it undergoes any chemical changes.  Silicone is a really complex material.  It is highly stable.  It is used in transformers because of its chemical stability, but part of that stability is because it has a reversible hydrolysis.  In a non-aqueous environment it reheals itself.  In an aqueous environment you are going to generate small molecules, low molecular weight molecules, continuously.  Because of this equilibrium, you can never extract them all out.  There is some concern, for instance, that there is a new shell that is being introduced, a fennel-based siloxane.  There is a real question about what its small molecules will do.  As far as I know, these have been very little tested, except perhaps internally by Dow Corning.

    So, you would like to understand the chemical changes and then you would like to know what kind of responses you might expect from those types of chemical changes.  Then, with that kind of data you can start making some reasonable estimates of the kinds of things you would look for.  It is obvious that this is not a very straightforward problem but it is clear that there are some very active species coming out.

    [Slide]

    If you look at this slide, this is from a book on immunology of silicone.  There was a symposium at NIH in 1995.  I presented one of the introductory papers on degradation reactions right after Dow Corning got up and talked about background of silicone.  There were a lot of papers on immunology presented.

    If you just look at this schematic diagram, you don't have a solid fibrous capsule.  You have a synovial type cellular layer, histiocytic.  Those things pick up the silicone that comes out through bleed.  They pass into the tissue.  So, at the very least, you have a part of the immune system that is picking up these tiny particles, carrying them somewhere, doing something, and a lot of that is not tracked, not known.

    [Slide]

    One example of the changes--this is a picture of the cover of the book and this is a histology slide.  So, it is processed in xylene and, yet, you see residual gel.  The residual gel indicates some cross-linking has probably taken place to allow that gel to stay in the slides.  The gels have been linked to adjuvant type reactions, and all, so it is interesting, provocative but it has not been followed up on as to what happens here.  Also, very tiny amounts, when they are distributed to very tiny particles, can create tens of square meters of surface area and that also has not been related to dose response.

    [Slide]

    If you look at this slide, particles of gel, even from oil when there is no rupture, also show that they become a gel.

    [Slide]

    One of the postulated mechanism is you could have oxidation.  It is well-known that lysosomes can produce things like hydroxyl radical or other reactive species which are known to oxidize silicone.  There are hydrolysis reactions that are well-known.

    [Slide]

    I tried to look over a little bit of the mass of volume of technical literature that came out.  D4 is one of the most interesting molecules.  I only found studies from D5 on up.  Again, there has been no discussion of what phenyl-containing coupling agents do, and there are silanols which are known to be very biologically active.

    [Slide]

    Here are summary points.  I see my red light flashing and I will just try to finish very briefly.  There are a lot of things that could be studied that are not being studied.  You need some independent investigators funded by organizations like NIH to get in here and look at some of these things.  I think you definitely need to keep looking at the data and try to do a better technology analysis before these things are approved for non-regulated use.

    DR. MILLER:  Dr. Whalen, can I ask a question of this presenter?  I wonder what you would suggest to us in terms of how to address all these questions and the relevance of all these questions, given the fact that there has been no evidence that has linked the implants to disorders.  I mean, you can raise lots of questions, and I share your concern about wanting to understand, as detailed as possible, everything that happens with the implants, but the quandary that I find myself in is are we going to find something in answer to these questions that will make us discover that there are health problems associated with it?

    DR. BATICH:  Well, one of the ways to miss important information is to put it in a lot of different situations.  In other words, there are very many different types of implants out there, very many different kinds of materials are releasing at many different rates.  If you put some good data in a lot of mixed bad data, you are not going to see certain relationships.  Sometimes it looks like there are no problems at all; there are very positive responses from implants.  Other times there seem to be a consistent--I don't know--group of symptoms.

    A lot of plastic surgeons I have talked to say they think there is something really there but they don't know what it is.  I think it behooves us to try to identify the kinds of things that could be coming out, and then you can study and see if there is a dose response.  The immune system is involved somehow because of the macrophages, but what it is doing I certainly don't know.  That is not really an answer but it is not a simple problem and there isn't good data to resolve it I think.

    DR. MILLER:  Thank you.

    MS. GILBERT:  I have a question.  Alisa Gilbert.  On your slide number seven you are asking the question what materials are released and you mentioned D4.  What is it about D4 that you think should be looked at?

    DR. BATICH:  Well, D4 is the monomer that silicone gel is made from.  So, when you make the shell and the gel there is frequently D4 present.  It is removed in different ways but it is a stable molecule in the sense that it is reformed again at very low rates by the gel itself and by the shell.  So, if you extract it completely and wait a while, especially in the presence of any kind of catalyst like sodium chloride or something like that, it will slowly reform.  So, there are a number of toxicological studies of D4 that have been published by other people.  D3 is more reactive and it is also interesting.

    MS. MALNACK:  Good morning.  I am Marilyn Malnack, from Gilbert, Arizona.  I am here to tell you about a successful surgery, and 25 years after I can say I am still satisfied with my implants.

    I had them in 1978, and the reason I wanted to have implants was to make my body a little more symmetrical.  I have nice hips and a nice waist but I was totally flat in my breast area.  I found a surgeon that did a wonderful job.  He told me about all of the risks that were associated with having a foreign substance introduced into your body.  I listened carefully and took a few months to think about it, and my husband agreed that it would be a great thing to have.

    So, I went in and had gelicone--gelicone!--silicone gel implants inserted in 1978.  I am still as active as I was then.  I am a healthy woman of 54.  I am very happy that I had them inserted.

    I don't know what else to say, except every person's body is different.  Your body is never static; it is always changing and when you make the decision to have this stuff done, you really need to look at all of the risks that are associated and decide whether you want to take those chances or not.

    Implants are a totally optional surgery.  Nobody has to have it.  Women seem to want to have these things done because we feel like we need to be more perfect than we are.  So, I think that is why a lot of women have it done.  Everybody has their own reasons.

    But I saw in the newspaper a small article by Inamed, that they were coming here, in front of the panel, to try to get silicone approved.  So, I e-mailed them and let them know that I had them for 25 years, and they called me back and asked me if I would like to testify, and I am doing that for my own self and for all the other women that have had successful implants and are happy with all of the results.  Inamed did pay for my travel expenses but that is all.  Are there any questions?

    DR. WHALEN:  I think gelicone is a great word and you ought to get on the web and trademark that right now before somebody else does!

    [Laughter]

    DR. CHOTI:  A question for you, how are you following up?  Are you concerned about leakage or rupture at this point, or what is your plastic surgeon telling you?

    MS. MALNACK:  You know, I haven't gone back to see my plastic surgeon because I had it done in Washington.  I am very aware of my body.  I am always looking at it, checking it and I think I would know if anything was leaking.  Some people are more in tune with their bodies and really, if you are going to have a foreign substance introduced, you really have to pay attention.  Even though it has been 25 years, I know that I can change and I am changing, and you always just need to pay attention to what is going on.  You can't just put them in and forget about it and go along with your life.

    DR. CHOTI:  What about mammograms?  Are you concerned at all about getting mammograms?

    MS. MALNACK:  Yes, I have had two mammograms and everything is normal.

    DR. CHOTI:  But it doesn't bother you about compression or worry about damage to the implants with the mammogram?

    MS. MALNACK:  No, but it does kind of hurt.  Ouch!  Of course, it does for all women.  It is not a pleasant procedure.

    MS. RUMSEY:  Hi.  My name is Leslie Rumsey.  I am from Pennsylvania.  I have no financial interest in this issuel; I have a very passionate interest in it though.  I had a little speech written but I sort of wanted to speak from my heart a little bit more.

    I was diagnosed with stage 0, non-invasive ductal and lobular carcinoma in situ in November of 2001.  Very delusionally, I thought at the most I would need was a lumpectomy and I would move on with my life.  I was told, however, that I needed a bilateral mastectomy and my world just came crashing down.

    I didn't even know how to deal with it.  I had two young children, two younger step-children, and there was no choice, breasts are removed and you go on from there.

    I researched on the Internet, talked to doctors, talked to nurses, talked to survivors about my choices for reconstruction.  They sort of dangle that out there for you, like everything else is minor--you are going to look great immediately after surgery.  I researched it all, and sort of wavered between saline and silicone implants until I had the expanders, and they were just very difficult for me to deal with.  They felt hard; unnatural.  My children couldn't nestle up to me.  I was used to them nestling up to me.  So, I made the decision to go with silicone implants.

    I had that done in June of 2002 and I have never regretted that decision.  They feel natural.  They look natural.  My children can lay against me.  It is just the most wonderful feeling.

    When you have seen yourself with breasts removed, and scars and the impact that has on you, it takes an hour just to get undressed for a shower, and in a short period of time, to look the way I look now, I can't describe in words how wonderful that is--to be able to show my daughter that you can have breast cancer and you don't have to fear it the way I feared it when I was growing up.  The movie of the week--you wake up; no breasts; your husband leaves you.  She doesn't have to face that.  She looks at me and she doesn't even see anything different about me.  So, that is something I really treasure.

    I have so much compassion when I hear what the women who have had negative results feel.  I listen to that and I would still make the same choice, and I would go through it, knowing that I am responsible; that I would need to go back to my doctor; I would need to know what is going on and take responsibility for my own physical health.  But it is something where I would still make the same choice for and go ahead with.

    In 2001 I was a victim of breast cancer.  When I had my bilateral mastectomy I became a survivor of breast cancer.  But I feel with all my heart that when I had the implants installed I became a thriver of breast cancer, and that is something I wouldn't change.  Thank you.

    MS. DOLLIE:  Good morning.  My name is Nikki Dollie and I am a silicone survivor.  I have no financial affiliations with anyone, except the next speaker that is my husband.  He drove 30 hours to get us here as it is that important for us to ask you to vote no to silicone.

    I have heard much talk of silent ruptures and that is a grave concern, but I talk of silicone gel as my personal, silent killer.  I was implanted in 1992 with silicone gel.  Had you observed me one year later or eight years later, you would have been observing a healthy, active, happy, trial attorney.

    I have developed a plethora of symptoms over a very short time span, and I was in a wheelchair with many symptoms identical to those experienced by what I call my silicone sisters.

    After explantation and removal of lymph nodes in my armpit and over my lungs in the year 2001, approximately six months after I first developed symptoms, I was out of the wheelchair within 72 hours of explantation.  I began immediate improvement in other areas as well.

    As a result of my gel bleed, my lymph nodes were saturated with silicone.  That is the pathologist's report.  No rupture.  My life was destroyed.  That is me, my victim's report.

    Today I am a shut-in, sharing many of the same diseases with which my silicone sisters suffer.  My life is a nightmare of illnesses and surgery after surgery.  Yes, that is one quick sentence but it is about the end of my life as I knew it.  This is the story of a gel bleed, ladies and gentlemen, and the devastation of my life and countless lives, my fellow implant survivors.

    I moderate an international support group for my wonderful women who can't be here:

    From Joyce in Pennsylvania--she asked me to tell you please do not approve the manufacturing of implants to kill the next generation as it is killing ours.

    From Kay in Oklahoma, we are the studies; the sisters.  I ask you to look at our bodies and consider the mail you have received about our pain and tell me how you can even consider placing a toxic killer back on the market.      From Rosanna in Florida, there is not enough research on these implants.  I have personally been very ill following a rupture.  I have worked with thousands of women over the last ten years that are sick and dying from the very same symptoms and diseases.  Why not study us?  I am the evidence.  We are the evidence, the women.

    From Colea in Washington, no one should receive silicone implants without being tested for sensitivity to silicone.

    From Susan in Texas, it is important for you to realize that despite suffering the ill effects of silicone, we represent someone's mother, child, sister, spouse, friend, etc.  We are important people and something horrible has been done to us with our exposure to silicone.

    From Michelle in Louisiana, please do not allow silicone to be the silent killer of the next generation as well.

    From Linda in Texas, having breast cancer at 29 was devastating.  Getting reconstruction surgery, recommended by my plastic surgeon, with implants--

    DR. WHALEN:  Ms. Dollie, you need to conclude, please.  Could you conclude, please?

    MS. DOLLIE:  Yes.  I just have two more.

    DR. WHALEN:  I am sorry, you need to come to your concluding sentence.

    MS. DOLLIE:  Ladies and gentlemen, based on what I have experienced with what was determined to be just a silicone bleed--and I say just a silicone bleed--very seriously, I ask you to vote no to silicone gel.  It was determined I had no rupture.  My pathologist's report showed that removal of the silicone in my lymph nodes is what allowed me to start breathing again.  I have had silicone removed, or about to be removed from my hands and my feet.  I don't believe this is a normal process of aging, and it took almost nine years for the first symptom to present.  Prior to that I was a happy, healthy, working attorney.  Had I known this would happen, had I been warned, I wouldn't be here today and I implore you to vote no.  Thank you.

    MR. DOLLIE:  Good morning.  I am Mike Dollie.  That was my wife, Nikki.  I have no financial affiliation with anyone.

    I don't have a clue what I am going to tell you.  I just want to speak from my heart here for a minute.  I have watched my wife go from a very athletic, very professional, vibrant attorney to a woman who is held captive in her own home, who can't get out of bed in the mornings until I bring her her pain meds.  Then, she is still there for a couple of hours till they take effect.  I have watched her go from somebody who is a published author to not being able to concentrate enough to read the newspaper.  I have watched her go from a woman who helped everybody do everything to somebody who now has to have someone help her.  It breaks my heart to see what has happened to her.  Everybody who knows her, knows what she used to be and what she is now.

    So, we ask jointly, as a couple, that you vote no in this situation.  Thank you.

    DR. LYKISSA:  Good morning.  My name is Ernest Lykissa.  I have been involved in the last--oh, since the years '89, '90 with silicone breast implant research.  Presently, I am involved in forensic and clinical toxicology in the city of Houston.

    When I was affiliated as a professor of clinical and forensic toxicology with Baylor College of Medicine in Houston, I was able to do extensive research with these particular devices.

    Oh, I forgot--my affiliations are that the National Organization of Women paid my ticket to fly up here and also paid for my stay last night in this hotel.

    In this Power Point that I present for you, I just summarize in the first four pages some research that was performed with mice at Baylor College of Medicine.  In order to remind you, this particular work was done at the time when we were told that silicone was inert, that there was no toxicity associated with it.  We were able to prove that there is an LD-50 associated with cyclosiloxanes.  We were able to prove, in our paper in Analytical Chemistry, that both the silicone and the platinum catalyst that is included in the low molecular weight silicone oil in order to polymerize that mixture and make it a good fill for the envelope so that it can be implanted in a human being, that material was passively leaking out of the porous envelope.  We were also able to show that there were toxic effects in the mice to the point where we also had death due to fatal hepatic and liver complications--hepatic and liver, I am sorry, I mean hepatic and pulmonary complications with the mice.

    As I said, in the second paper that I have there, we are showing also that platinum was being released in a very significant manner from those implants.  What we were saying was that the devices were depolymerizing with aging.  Remember, we worked not with brand-new, shiny implants.  We worked with devices that had been explanted from women after they had been in situ for a period of up to ten years, sometimes more.

    It seems that these devices, when they were manufactured, had convinced the manufacturers that they were a good device.  And, I agree with them.  They were looking at something very shiny, off the show room.  The problem is once you put it in a human body, once you subject it to the rigors that those ladies that were being implanted were subjecting them to, those devices were coming very quickly to a very high failure rate.

    I am not talking about ruptures now.  I am talking about where optically you can look at the device and you see nothing wrong with it.  Of course, you see some small tears.  If you put it under the microscope you see a lot of different things happening.  The fact that the capsule is formed by the body shows you a very strong reaction of the body.  It is rejecting it like a cyst.  It is encapsulating it like it was a cyst.

    So, we know that from day one that the body is not reacting very well.  In the old days the plastic surgeons were known to literally hit the women in the breast with a two by four literally to break the capsule because they would get hard.  Women obviously didn't want their breasts to be hard.

    After Baylor College of Medicine, in the laboratory, was able to test women that had been implanted and had been explanted, we were able to test their blood, their urine, hairs, nails, sweat and so on and so forth, and what we found was that there was still silicone.  Obviously, the silicone that had migrated in their body, in small foci throughout their body, was still releasing D4s, D3s, D5s, D6s, D7s, and so on and so forth.  These are the low molecular weights that get polymerized with the introduction of the catalyst of platinum and put in a gel form from the oil.

    So, once we had that situation, we found that these materials were still present in their bodies.  Some of them were worse than others.  Let's don't forget that it is not one breast implant out there, there are a lot of models.  There are a lot of batches.  When they were manufacturing them, if the batch did not gel properly according to the formulation, they went in and sprinkled a little more hexachloroplatinic acid or whatever else they needed.

    So, we are talking about a little bit of alchemy here.  We are not talking about chemistry; we are not talking about a controlled science.  Remember, these devices were not produced under strict controls.  I am talking about the early days.  Slowly, as we saw the symptoms being developed, as we saw women complaining, they went back and they used that as quality control.

    Of course, they attacked everything the scientists were trying to do by saying we have financial--you know, obviously I am not a millionaire and I am not going to make my living doing this, but what I am here to tell you is that my research has shown that these particular devices, with time they are like tires.  They have enough mileage on them and once they get enough mileage on them they will fail.

    So, I implore you, in your decision-making that you take that into consideration--that you ask the manufacturers to provide you with data that they have done stress testing on these devices.  I implore you, like you do with aspirin and like you do with vitamin pills, put an expiration date on these devices.  Demand that the manufacturer puts an expiration date on these things.  Just tell them, based on their studies, based on your decisions, I implore you that you do that because, if you don't do that, your names will be known to many of these women and somebody will be testifying against you.  Remember that.  You are handling here human lives.  I took an oath to cause no harm--I don't know about you--and I uphold that.

    In the last conclusive evidence that I am going to give you here so I can let other people talk to you about more important things, I think the recipients of these devices should be forewarned of the increased risk of the systemic toxicity with prolonged implantation past those expiration--

    DR. WHALEN:  Doctor, would you conclude, please?

    DR. LYKISSA:  I am done, sir.

    MS. GILBERT:  I have a question.  You don't have page numbers, but in the platinum in samples of women with silicone gel or silicone saline implants and their children, how long out did you do your studies?  I mean, how far away were the women from implantation and what about children?

    DR. LYKISSA:  As I said, you have to remember that these were not every case that we tested.  At the time we tested it, it was a custom case.  I mean, it was not like some type of--to answer your question, I will say that we tested these women with their implants, we tested them for a period of about two months to three months in vitro in order to see what they were releasing in our laboratory under the conditions that simulated the human body.  When we tested them, as I said, with the saline implant we did not find any toxicity to talk about that was, you know, very significant.  But with silicone breast implants, I can guarantee you.

    The Germans have confirmed our research.  So, I can stand up here and tell you that our research is valid and you can look at it with scientific criteria that has been published in Environmental Health Perspectives, American Journal of Pathology, Analytical Chemistry.  So, we are not talking here about, you know, something that came out of somebody's closet.

    DR. MILLER:  Can I ask you a question also?  Could you tell me about ExperTox?  How long has ExperTox, Inc. been a company?

    DR. LYKISSA:  ExperTox, as I said, is a clinical and toxicology laboratory and has been in practice now since the year 2000.

    DR. MILLER:  What percentage of your studies are done related to silicone problems?

    DR. LYKISSA:  I would say less than five percent.

    DR. MILLER:  So, you do toxicology testing--

    DR. LYKISSA:  We just do toxicology, sir.  We just have ICPMs, DCMs, LCMs, all the best technology.  You give me the samples; I give you answers.

    DR. MILLER:  And one other question, you know, you list a lot of toxic appearing things and you say that the longer the implant is in, the increased is the risk of toxic, you know, systemic effects.  Yet, we have no epidemiologic data that suggests there is a linkage between systemic illness and the implants.  So, how do you square these epidemiologic studies and the questions raised by this kind of information?

    DR. LYKISSA:  Well, the epidemiologic studies were not our concern.  We were testing patients, individual patients.  Obviously, the patients that had problems came to us.  The patients that did not have problems, they had no use for ExperTox.  The people that I see in my laboratory, sir, they are all suffering from some kind of toxicity most of the time.  The best news you can get out of my laboratory is that I found nothing and that happens very rarely, unfortunately.

    In these particular cases, the patients that I tested, they had been seen by rheumatologists, dermatologists.  They were suffering from silicone deformities.  They had sores on their bodies.  I mean, a very obvious disease state had established itself in their bodies for a long time.

    So, how do I square it off?  Believe me, I have seen enough people and enough sickness to tell you that I am so convinced of this, and I am very hard to convince, I promise you that--the people that I have seen have been sick, and I know that the fact that we have hexachloroplatinic acid release from those devices, which is an alchemist's product--it is platinum treated with aqua regia, for crying aloud, from the 1400s.  You know, we have this material released from the body.  I know that is the reason for the sensitizations and I know that the silicone, when it starts being released in the body, just adds to the burden and that is what breaks the camel's back.

    DR. MILLER:  Thank you.

    DR. LIEBERMAN:  I have a question.  You clearly have this data and clearly there is a lot of variation in the symptoms--

    DR. LYKISSA:  Oh, yes.

    DR. LIEBERMAN:  So, I wondered if you could help us to think about what factors might influence whether a woman has symptoms or not.

    DR. LYKISSA:  Okay, I will start by telling you that since all my graduate work up in Montreal, in medical school and following my graduate work with a Ph.D. and all these other things, what I learned was let's not forget the DNA.  Let's not forget the genetics here.  So, we have predispositions from the genetic factors.

    Number two, which makes it very complicated for any one of us in this room to have a clear understanding of what is going on, there were multiple models of breast implants.  There were the Dow Corning; there were the McGhan; there were this; there were that.  There were batch variabilities.  We went in and we tried to make ends meet.  So, this is another factor, what is the device you are talking about?

    We are all standing up here like, you know, the monkeys in 2001, trying to tell you that we know what the fact is.  We don't know what it is.  These are devices that were manufactured under different conditions.  So, these are the factors you want to look at.

    Then, number three, and very important, is the life of the woman.  What is she going to do with her body?  Where is she going to live?  Is she going to live in a cold climate?  We found out that as you turn the temperature up these materials depolymerize a lot faster.  So, if she is going to live in Florida with her breast implants versus Upstate New York, we are going to have different factors there.

    Also, we found out that lipophilicity--you know, the pores on the envelopes seem to allow this migration and depolymerization in the presence of stearic acid, for example, which is the human adipose tissue.  Also, unsaturated fatty acids seem to help that material.

    So, I can stand up here and tell you that I know but, you know what, I really don't know.  I wouldn't want your job.  Thank you.

    DR. LIEBERMAN:  I have one more question.

    DR. WHALEN:  I am afraid that is all we have time for right now.  We will try to maybe come back to it if we can, because we have multiple other speakers that are coming.

    I do want to let the audience know, especially the people who have spoken who wonder why different people get different periods of time, we have tried to make that announcement in advance but we weren't able to at that particular time.  But one of the subsequent speakers did donate five minutes of their time to the doctor.

    MS. SHEPPARD:  Good morning.  My name is Audrey Sheppard.  I live locally and have no conflicts.

    I headed the FDA Office of Women's Health for four years, from 1996 through '99.  Regarding silicone gel implants, these years produced an action-packed time.  My office worked closely with the Center for Devices to meet repeatedly with industry and women advocates to revise the breast implant booklet and place it on the web, and to sponsor FDA's rupture study and more.

    I left the FDA nearly four years ago.  Perhaps distance creates perspective.  So, let me summarize what I see as key considerations as you mull this critically important decision, whether to recommend that FDA approve the devices for widespread augmentation as well as reconstruction, releasing them into the bustle of the marketplace.

    One, as we have heard, over time silicone implants rupture and cause other significant local complications.  If approved for augmentation, considering the increased popularity of them, ultimately millions of young and middle-aged women are each likely to face a number of additional surgeries.  Based on the duration of the data submitted, it is certainly impossible to conclude this will not happen with the devices you are considering.

    Two, we are told various neurological diseases, perhaps atypical syndromes, can't be ruled out in a subgroup of implant recipients.  Here we have met and heard the personal stories of some of these women and their illnesses.  I would suggest that FDA has the responsibility to them and future women to apply a high standard for establishing reasonable safety.

    Three, FDA approval is the gold standard.  Should there be approval, consumers and physicians will take this as a clear indication of out-and-out safety.  You are well aware that augmentation is not a medical necessity which would justify a high degree of risk.

    Last, if FDA were to condition approval on rigorous post-approval requirements, this would be well intentioned but could not be successfully enforced.

    I see my time is getting short.  Inamed's proposed postmarket surveillance by mail seems less than stringent.  Placing much stock in hopes of meaningful postmarket data down the road is no substitute for a hard up or down decision now.

    I have been immensely impressed with the seriousness of these deliberations.  The health of millions of women rest in your hands.  Thank you.

    DR. CONNELL:  Good morning.  I am Dr. Elizabeth Connell.  I have been kindly yielded some time from Susan Lynch Hunt.

    I am currently Professor Emeritus in the Department of Gynecology and Obstetrics at Emory University School of Medicine, in Atlanta.  I appreciate this opportunity to present my experiences and views to this panel.  I have no financial relationship with Inamed and I have received no compensation or reimbursement for my appearance today.

    For more than 50 years I have had the privilege of practicing medicine and providing health care to women.  I began as a general practitioner in rural Maine, following which I received training in OB/GYN.  I then went into practice and also developed clinics for women in Spanish Harlem and at Columbia University in New York City.

    In addition to being a health care provider during these years, I also had the opportunity to conduct numerous research projects.  I have published over 200 scientific peer reviewed papers.  I also served five years as Associate Director of Health at the Rockefeller Foundation, and worked with the U.S. AID as a member of the agency's research advisory committee.

    I have also had a long involvement, starting in 1970, with this particular agency.  I have served on seven different advisory committees.  I have chaired three of them, including the first one dealing with silicone breast implants.

    To go back more than a decade now, I was invited to chair this panel when it was convened in November of 1991.  We were given two major charges by the then Commissioner, David Kessler.  First, we were to evaluate the PMAs of four companies who had submitted data on their breast implant products.  Then, we were to advise the FDA as to whether or not the PMAs were adequate for approval.

    Second, we were asked to determine if there was a public health need for silicone gel-filled breast implants.  In this context, we were to decide whether particular groups of patients, specifically those who had undergone major breast surgery mainly for breast cancer or for significant deformities, should be viewed as distinct from the larger group of women who were receiving implants for augmentation.

    Following three arduous days of hearings from dozens of witnesses, our panel deliberated and determined that the data from the four manufacturers were not complete enough to warrant approval at that time.

    However, I think it is critical to note that this was in no way a statement that we found these devices unsafe.  Nor did we determine that they posed a health threat to women who had received them.  Had we determined at that time that this was the case, we would have recommended that they immediately be removed from the marketplace.

    As to the second mandate, whether they met a public health need, we agreed there was ample evidence that they held a significant importance for both reconstruction and augmentation patients.

    Early in the following year, February of 1992, I again chaired this panel.  Before the follow-up meeting occurred, the FDA had asked for a voluntary moratorium on silicone breast implants pending evaluation of new evidence that potentially linked implants with autoimmune disease.  This time also Dr. Kessler gave us a mandate.  We were not to revisit the decisions regarding the PMAs that we had made at the previous meeting.  Because of the new information, he asked us to consider two questions.

    First, given several concerns, including leakage and rupture of the implants, what information should be given to women who already had them?  Second, given the new information, should these devices be allowed to be used in the future and, if so, under what conditions?

    After three more intense days of testimony and deliberation, we concluded again that although more research was necessary, there continued to be a public health need for these devices.  We recommended that women always receive the best available scientific information before using these devices.  We also concluded that there were no scientific data indicating that silicone implants posed a significant health threat to women, especially in the area of connective tissue or autoimmune disease.

    In summary, we determined that silicone breast implants should continue to be available, but that more study was needed to answer the remaining safety questions.  The panel also recommended that these implants be made available to all individuals who needed them for reconstruction, most particularly women who had breast cancer.

    Additionally, the panel recommended that some women be allowed to have these implants for breast augmentation so long as their surgery was conducted under clinical protocols, designed by appropriate agencies and organizations such as the FDA, NIH, plastic surgeons and other relevant groups.

    Over the past decade, I have continued to review the growing body of scientific evidence regarding the safety of silicone breast implants.  There, as you know, have been numerous studies, both here and internationally, carried out by recognized professionals seeking evidence-based information on this issue.  They have been conducted by such prestigious institutions as the Mayo Clinic, Harvard Medical School, the University of Michigan and Johns Hopkins, and the United Kingdom Independent Review Group, among others.  It is now 2003 and I believe that today there is sufficient valid evidence to answer the questions that we posed more than a decade ago.

    To put this issue into proper perspective, I believe that all of us have a stake in this matter.  We need to have confidence that medical and health policy decisions will be grounded in legitimate science.

    In conclusion, I believe that you are fortunate to have more than a decade of new research to consider, information that, unfortunately, was not available to us during our earlier meetings.  I continue to believe there is no evidence for significant health risks to women and that for many women the benefits will outweigh whatever risks there exist.  I think it is critical, and we said this very clearly in 1992, that women need to be given the best available evidence at the time that they are considering the use--

    DR. WHALEN:  Can you conclude, please, doctor?

    DR. CONNELL:  I am.  Also, I think we would be well advised to continue to monitor the situations, as we had recommended, in line with the current FDA protocol.  Thank you.

    DR. WHALEN:  Seeing no questions, we are on track to be a little bit ahead right now.  I can't reconcile that with yesterday, but we are.  I would hope that FDA and the sponsor will be prepared to make their final summations and comments prior to lunch, with the schedule we are presently on rather than after lunch as was originally designed.  We will take a 15-minute break and reconvene at 10:15.

    [Brief recess]

    DR. WHALEN:  We will have further open public comment.  We are left at this juncture with such comments coming from members representing various societies.  So, if the first of those speakers would, please, proceed to the microphone?

    MS. HEMSTRA:  Good morning.  My name is Erin Hemstra, and I am here to read the testimony of Wade Clegg, from Panama City, Florida, who could not be with us today.  Neither of us have any conflict of interest.

    Silicone gel breast implants break and leak.  When that happens, implants can cause pain and debilitating illness.  If FDA were to return this inherently debilitating device to the market it would be a very sad day in government oversight.

    Silicone gel implants allow for years of debilitation.  For healthy women, electing augmentation often assures that no insurance coverage will be provided to assist when problems occur.  The history of these devices clearly shows that any conclusions about safety need to be based on long-term testing of no less than ten, but preferably 15, years.

    The real question is have the risks and complications that have been seen in previous gel implants been eliminated by Inamed silicone breast implants?  Judging from the lack of long-term research data, the answer seems to be we don't know.

    If you recommend approval another group of teenage and young women face a future of debilitation.  Have any risks and complications been avoided by the implants that you are reviewing here today?  If the manufacturer claims that their product is better than previous gel implants, there is only one way to prove that--to study women who have had the implants for a long enough time to find out what happens when the implants break.

    It is not until the implants are in women's bodies for several years that it is possible to learn if they will break, leak or cause health problems.  Two years of research or even three, four or five years is not enough.  Thousands of women have had their lives diminished because they believed breast implants were safe.

    I hope that you will not repeat this fraud.  I plead for this FDA advisory committee to extend this process and continue to restrict access to gel implants while research continues, rather than approving implants which have not been proven safe for the long-term use.  Thank you.  Wade Clegg.

    MS. ROTH:  Good morning.  My name is Lynda Roth.  I am founder and director of the Coalition of Silicone Survivors, a group of over 10,000 breast implant survivors.

    I paid my own way here.  I received some help from friends and other implant survivors toward additional expenses.

    In 1990 I was diagnosed with breast cancer.  Understandably, I was in shock.  When presented information on silicone breast implants, I trusted that what my highly respected plastic surgeon and other doctors were telling me was true.

    I soon found out there were many risks that were not disclosed.  My implant hardened immediately, resulting in a great deal of pain and a very misshapen breast.  It spontaneously and silently ruptured within a few months.

    It was removed shortly thereafter, but much of the silicone gel was not.  I had a second implant removed a year after the first, and it was already sagging a great deal.  I had lost a lot of silicone.  My surgeon told me that silicone gel was inert and would not harm me.  I can assure you that my concern for having silicone implants was truly uninformed.  The pain and disfigurement that I suffered was immense.

    Within a year I was having problems with extreme fatigue, balance, memory, concentration, visual disturbances, fibromyalgia, etc., etc., etc.  In '94 I was diagnosed with lupus.  There is no family history of this or other related autoimmune problems.  Was it just a coincidence?

    It was certainly not a coincidence that I had small, hardened, rubbery lumps of silicone come out of my forehead for three years, or that I had silicone granulomas on my arm and leg.

    I still have neurological problems.  By the way, both neurologists who diagnosed this in '92 had never seen a silicone patient and both put in their notes that they thought silicone toxicity caused my problems.

    I have a masters in social work.  I lost my job because of my health problems.  I also lost my health insurance.  I am basically uninsurable.

    Women who want implants today are told they must waive the right to sue the manufacturer.  If the implant makers are so sure their product is so safe, why would they do this?  It may be acceptable to some that an implant can harden; that it can move; that their body may reject it; and an amount of pain may be acceptable to some.

    But please remember that silicone injections in the breast were banned by the FDA because women had serious health problems and died from injections.  A ruptured silicone implant is no more nor no less than a massive silicone injection.  All silicone implants will rupture in time.

    I believe many women could evaluate the risk of these devices if they had enough time and enough information.  Unfortunately, women who are told they have a life-threatening disease, such as cancer, are not in any objective shape to make these choices, especially when they are told by their plastic surgeon that these devices are safe, as I was.

    Reports to our group still show very few women are truly informed of the risks prior to these devices.  The studies that have been conducted by the manufacturers, supposedly monitored by FDA, are not run the way clinical trials are expected to run.  Many women report to groups like mine that they have never been contacted for follow-up in these studies.

    What good are these follow-up safety studies if many of the women are not contacted to see if they are problem-free and healthy?  I have been a group leader since 1991.  I am astounded at the fact that hundreds of thousands of women that registered and claimed injury from silicone implants in these lawsuits--that the rosy picture painted by Inamed and other people is not accurate.

    Studies that covered two years or five years inevitably will not find the kinds of problems that group leaders like myself have seen and heard about.  We all know from asbestos, dioxin, radioactivity, mercury, PCB, DVT and others take 20 to 30 years to manifest.  Why would silicone be different?

    If you now approve implants based on two years of data, while allowing eight more years to collect more, hundreds of thousands of women more will be exposed to these toxins before more evidence is in.  And, you have no way to enforce that the studies are done properly.

    Women receiving implants today may not be ill for 10 to 25 years.  What kind of future are we guaranteeing to them?  And, do we want 17-year old women to have these implants?  Is that a responsible decision for this committee to make?

    DR. WHALEN:  You need to conclude, please.

    MS. ROTH:  You have a very important decision.  I hope you will consider all the women who have been harmed by their silicone gel implants before you make your recommendations.  Thank you.

    MS. GILBERT:  Excuse me, can I ask you one question?

    MS. ROTH:  Sure.

    MS. GILBERT:  Are you the director?

    MS. ROTH:  Founder and director of the Coalition of Silicone Survivors.

    MS. GILBERT:  Do you guys actively--are you participating in any kind of research?  Are you collecting information on all these survivors?

    MS. ROTH:  You know, we would love to see a retrospective study of the people who really have had the problems but the manufacturers will never do that because there is too damned much evidence.

    DR. ZONES:  Good morning.  My name is Jane Zones.  I am a medical sociologist and I am here as a member of the Board of Directors of Breast Cancer Action.

    Breast Cancer Action is the first national breast cancer organization to refuse donations from any organization that would represent a conflict of interest and I have no conflict of interest here.

    Twenty years ago I sat on this panel as a consumer representative when FDA was considering whether or not manufacturers should be required to submit evidence of safety of silicone breast implants.  At that time, the only other woman in the room was the transcriber of the hearings.

    Things have gotten a lot more sophisticated since that time, but the one thing that hasn't advanced appreciably is our understanding of the long-term safety of silicone breast implants.  Twenty to thirty percent of women who have mastectomies choose to undergo reconstructive procedures with clear psychological and perceived appearance benefits, at least in the short run.  Many of these women are encouraged by their surgeons to have additional surgery on the unaffected breast in order to provide a better match. Women with high genetic risk of developing breast cancer also have been encouraged in many cases to undergo prophylactic double mastectomy, followed by reconstructive surgery.

    We have seen at these meetings that women who have reconstruction with implants after mastectomy experience much more complications than women who receive implants for breast augmentation.  Many women still do not receive detailed information about complications as part of the informed consent process.

    While the Institute of Medicine did an admirable job of compiling the accumulated evidence regarding the effects of silicone breast implants, they seem to have accepted the literature at face value.  To take a single example, one of the best and largest studies of silicone breast implants which shows no association of the devices to connective tissue disease, the Nurses Study, reveals considerable conflict of interest.

    Much of the research on implants is sponsored and carried out by those with a vested interest in the results, which is known to bias outcomes compared to independently sponsored studies.  Authors, including the lead and corresponding authors of the Nurses Study, variously received grants from manufacturers or payments from law firms representing manufacturers.  Two major investigators resigned from the project because of the appearance of conflict of interest, though one remained an author in the study.

    There are other concerns with the Nurses Study which were not addressed by the IOM committee.  The researchers report a mean follow-up after surgery of 9.9 years, with a range of one month to 40.5 years.  It is not clear how this was calculated since silicone breast implants have only been used since 1963, fewer than 30 years before the study cut-off.  Including even a small number of cases extending to over 30 years could inflate the mean follow-up substantially.

    Reported health problems of women with their breast implants occur with greater frequency as implants age in the body.  Long-term follow-up is a crucial variable in examining breast implant safety.

    As with other major studies of connective tissue diseases, the Nurses Study used only diagnosable diseases as outcomes and did not examine signs and symptoms.  Finally, although the sample size was very large, over 86,000 women, the prevalence of connective tissue disease in the population is very small, and the number of those with both connective tissue disease and breast implants, if randomly distributed, is extremely small.  The sample would have to be tremendously large, over 60,000 women with breast implants and twice that many controls, followed for ten years each, to have enough power to detect a doubling of relative risk of scleroderma, for example.

    The authors themselves conclude that because of the infrequency of occurrence of connective tissue disease, the study cannot be considered definitely negative.

    Recently, established medical perspective on two breast cancer related issues has been shown through randomized clinical trials to be completely wrong.  Doctors massively opposed randomization of their patients to control groups because they so thoroughly believed in the safety and efficacy of HRT and high-dose chemotherapy.  Tens of thousands of women were unnecessarily harmed because these beliefs were not true.

    It is unlikely that we will ever again get the opportunity we had 20 years ago to conduct sound and independent trials with long enough follow-up to answer the questions we continue to have about silicone breast implants.  We urge the panel to not recommend approval of this device which has still unknown long-term physical consequences.  Thank you.

    DR. ANDERSON:  May I ask a question?  First, in the study that you cited, I happen to have the abstract, and the issue about 40.5 years follow-up, what they are saying is that they had up to 40.5 years follow-up for the entire cohort.  They were looking at the connective tissue disease patients.  So, I don't think that that is an issue.

    But I think you made a very serious allegation against the authors of this study where you suggested that in the Nurses Study they were biased because of funding from private companies.  Do you have any data that they received funding prior to the publication of the study, as opposed to being--

    DR. ZONES:  Oh, it was in the disclaimer.

    DR. ANDERSON:  In the disclaimer of the Nurses Study?

    DR. ZONES:  Yes, the article is Sanchez Guerrero, in The New England Journal.

    DR. ANDERSON:  Okay.

    DR. ZONES:  Yes.

    MS. PEARSON:  I am Cynthia Pearson, Executive Director of the National Women's Health Network, an independent member-supported organization dedicated to safeguarding women's health rights.  We have no conflict of interest.

    We have reviewed the data that the FDA made available on its website on Friday.  We have listened to the sponsor's presentation yesterday, the FDA's review, and listened carefully to the panel's discussion last night.  Based on that information, I would like to use our time this morning to respond to four important points that I believe the panel has expressed over the last day.

    These points are that at least some panel members articulated very clearly that they believe that the large body of evidence looking at the health of women with implants, in general, is conclusive and is enough, and shows that long-term risks don't need to be worried about because of this literature.

    Two, I have heard some members of the panel say that the short-term increase in chronic tissue disease symptoms that were documented by the Inamed study is either not clinically meaningful or not clinically interpretable.

    Three, we have heard panel members say that they believe that it is important and possible to get more information after the approval of these devices, if they are approved.

    Four, some panel members have said that consent may make it all okay, good informed consent that lays out all the information, then appropriately allows a woman to make her own choice.

    I believe there are problems with each of those assumptions and would like to address them.  First, the issue of chronic tissue disease symptoms, there were questions, legitimate questions, in the absence of a control group, about to what extent are these increases in the symptoms, as we all saw posted yesterday, just a sign of normal aging, and as the night wore on to midnight there were jokes about maybe it is just a sign of normal fatigue because we would all score high on these now.

    We understand the problems with comparing to another study, but I would just like to point out that there are other studies that started with healthy women, that followed them over a period of years, that did not see these increases.  I will just take the Women's Health Initiative, which was a very large study that enrolled healthy women that were, on average, 30 years older than the average age of augmentation patients and, as reported in the last year, over a 4.2 year follow-up there was no worsening in mental health, general health, bodily pain, energy or fatigue.  I emphasize fatigue because to compare to the two-year follow-up in women at median age 34 years, that doubled in two years.

    So, we are concerned that these increases are at least worrying.  They certainly aren't conclusive because of the study design.

    Second, we disagree with the people on the panel who articulated that the literature gives us assurance that we don't need to really worry about silent rupture.  It would be nice to know why implants rupture; it would be nice to know how much of the silicone gets outside the capsule, but in the end we don't really need to worry because all these studies show that there is no conclusive cause and effect relationship between implants and harm to women's health in the long term.

    I just want to repeat what one panel member said yesterday.  If you look for a needle in a haystack by throwing the hay up and you don't find it, that doesn't mean that if you used a metal detector you wouldn't find that needle.  What that means in these women's lives is to do studies of long-term users with the power to find an effect.  Those studies have started to come out since the IOM review.  They have shown some troubling associations between suicide and other types of cancer.  They are not conclusive but they are troubling and post hoc speculation doesn't make suicide risk go away when it is shown repeatedly in three of these studies that have the power to find it.

    Third, we heard some panel members say that the need for more data will be remedied by what comes in post-approval, if the devices are approved.  The data that have been heard yesterday are from one to three years of a ten-year plan.

    I want to just remind the panel that while in this case the study from which you are hoping to get data post-approval was designed and begun pre-approval, I believe it is really crucial for you all to remember that the FDA's enforcement power to require post-approval data is very limited.  As far as we know, the FDA has never taken action against a product because of a sponsor's failure to complete post-approval studies.  If you believe that we need more data, you had better ask for it now, pre-approval.

    To respond to the fourth issue, the panel believes that women have the right to choose after excellent informed consent.  So do we.  But if important information does not yet exist, informed consent is inadequate no matter how long and detailed the patient information brochure is.  We believe that the right to choose is an illusion without the information to support a fully informed choice that has a full explanation of important and relevant risks and benefits.

    So, to conclude my remarks, I want to say that 12 years ago the FDA said there wasn't yet enough data to adequately evaluate the balance between risks and benefits.  Twelve years later we still don't have answers to women's important questions about the long-term effects of Inamed silicone gel-filled implants and women are counting on the FDA to take the right action to get those questions answered.  Thank you.

    MS. DICKERSON:  Good morning.  My name is Mary Dickerson.  In 1994 I was diagnosed with breast cancer.  Three weeks after my diagnosis I went in for a mastectomy.  I did have reconstruction.  My doctor used a tissue expander and about six months after that I had a saline implant put in.  I had that for six years.

    Three years ago, in December, I had a silicone implant put in and I just want to tell you a little bit about the differences.  I feel better with the silicone.  I look better with the silicone.  It is more natural.  It has a more natural feeling.  I can wear clothes better.  I just feel more comfortable with it.

    Having a saline implant inside of my breast was like having a tennis ball.  I couldn't wear a button-down shirt like this.  There were obvious differences, although we tried to make my other breast my reconstructed breast.

    I was 36 years old at the time and I knew I had no other choice but reconstruction.  My doctor worked very closely with me on what would be best for me.  I just want to say that for the past three years, with my silicone implant, my labs have all been fine.  I see my oncologist diligently.  I see my plastic surgeon diligently.  And, I am just here to ask you to give the women the right to choose.  Thank you.

    MR. KELLY:  Good morning.  My name is Joe Kelly.  I am from Minnesota.  I am president of the national, non-profit Dads and Daughters.  My organization paid for my trip here.  I have no conflict of interests.

    Everyone knows that silicone implants have risks.  You have to decide whether the benefits outweigh the risks.  I have never testified at an FDA meeting before but I am here today because of our very great concern about the growing use of implants among girls, and the unchecked cultural pressure on girls and boys to value how a girl looks more than who a girl is, and a woman also.  This pressure is toxic and too often fatal for our daughters.

    Under current FDA restrictions, teens under 18 cannot get elective silicone implants.  If you approve these implants, regardless of the restrictions you ask for, they will be available for off-label use, just like saline implants are today.

    Teenage girls in this culture are dissatisfied with their bodies and some will do anything to fit our culture's narrow, unrealistic genetic heritage-defying definition of beauty.  They will smoke to lose weight; use alcohol to numb the pain of not measuring up; spiral into depression and other mental illness; abuse a laxative and induce self-vomiting; and they will choose elective plastic surgery regardless of the risks.

    Girls' responses to the toxic beauty myth of our culture have serious, sometimes fatal health consequences.  And, that doesn't even touch on the social harm emanating from valuing appearance over substance in human beings.  We have a word for that phenomenon, bigotry.

    Perhaps most disturbing is the incredible number of people actively exacerbating this situation and selling our children's well being down the river to make money.  According to news reports, the most popular high school graduation gift this year in the U.S., in order of popularity, is cash, plastic surgery, cars.  The number of breast augmentations in girls 18 and younger has more than doubled since 1986.  Research shows that teenagers are the most likely age group to be dissatisfied with their appearance, especially features that do not meet culturally determined stereotypes emphasized in mass media, but that dissatisfactions lessens with age, as any parent with common sense knows.

    Although the FDA approved saline implants only for women 18 and older, there are no restrictions on the procedure so doctors perform on patients under 18 but medical associations, such as ASPS, apparently have no official position on teen surgery.  Breast implants have to be replaced when they break.  That is surgery that young women may not be able to afford and which may harm their health.

    Perhaps most outrageous to me as a father is the way that implants interfere with mammography, obscuring breast tumors.

    Finally, is it appropriate to perform cosmetic surgery on patients whose bodies are still maturing?  Unfortunately, no one has conducted studies or clinical trials on the safety and long-term risks of breast implants in patients under 18 or, if they have, the results have not been revealed.

    I think denying approval is your only reasonable response, though my argument might be a bit different than most that you will hear.  Even if it was the case, which it isn't, that no physical harm ever results from breast implants, your approval would endorse capitulation to an "appearance first" cultural standard that is dangerous and health-threatening to our daughters and, I might add, to our sons.  After all, would you tell your son that the size of a woman's cleavage is more important than the size of her heart?  Not unless you wanted to set him up for failure in life-long relationships.

    These "appearance first" cultural pressures have concrete negative consequences and I ask you to imagine your daughter's or your granddaughter's face in the story I am about to tell.  When we started Dads and Daughters we hired an immensely talented, committed young woman, named Heather Henderson, as our deputy director.  One morning, in September 2000, she did not come to work, which was very unlike her.

    I eventually went up to her house where I found Heather laying face down on the kitchen floor, dead of a heart attack at age 27, after an 11-year battle with bulimia.  It is obscenely ironic that Heather died of the very "appearance first" insanity she spent her life fighting.  But I think she died because there are not enough others of us out here, raising bloody hell about the waste of obsession with appearance that leads to deadly eating disorders; the waste of obsession with appearance that leads girls to smoke in order to lose weight and then develop breast and lung cancer as a result; the waste of obsession with appearance that leads girls to fall for elective breast enhancement and a lifetime of health risks, surgery and providing elective profits to implant providers.

    This is where you get to take your stand.  Please put your children's face in the picture and do what you know is best for everyone's health and say no.  Thank you.

    DR. WHALEN:  Mr. Kelly, can I ask you a question?  Your passion and the cogency of your argument is extremely well conveyed but, since you asked us as panel members to visualize your daughter, can I ask you a question in return?

    MR. KELLY:  Please, sir.

    DR. WHALEN:  If you visualize your daughter, or your wife or your sister a few years from now with breast cancer, does your argument change at all in terms of the reconstructive argument?  Or, is your off-labeling concern sufficient to even limit for that population of people not having silicone breast implants?

    MR. KELLY:  Well, first, thank you for your compliment about my age; I have adult daughters.  I have to say that, you know, my feelings are probably not quite as strong when it comes to reconstruction but they are not much less strong either.  I was talking about this, this morning with someone.  I have a mother who had severe polio when she was a young person.  It damaged her appearance.  It damaged her ability to get around.  It never bothered her; she went on with her life; she dealt with the imperfections of her experience and made amazing contributions to her family and to the world.  It is a challenge for all of us to deal with our imperfections and our disabilities and the struggles that we face.  I don't think it is worth endangering our future health to deal with something that is ultimately an internal struggle and decision that we have to make about how we live our lives.

    DR. WHALEN:  Dr. Miller?

    DR. MILLER:  Can I also ask a question?  I appreciate also all your perspectives.  I wonder, given your perspectives, do you feel that there is any amount of safety information which could be generated about the implants which would make them suitable as a procedure?  Or, is the mere principle of putting in an implant something which you oppose as a baseline?

    MR. KELLY:  No, I wouldn't oppose an absolutely risk-free implant, no.  But this certainly doesn't look or sound like a risk-free implant.

    DR. MILLER:  Just as a conjecture, if the implants could be proven absolutely with no risk whatsoever, zero risk, would the risk/benefit of the implants be suitable in your mind at that point to make them freely available?

    MR. KELLY:  You know, if I had my druthers I would say let's make them available to people who need them for reconstructive purposes.  I think the whole emotion of elective, trying to change our bodies from what they are genetically wired to be, is absurd and it is part of a larger cultural problem that is really harmful to all of us, and especially to our children.  I think it is important to see it in that context, that we are harming our children, and I think particularly marketers and people who are making money off our children's insecurities are hammering at our children with the notion that how they look is more important than who they are and what they can do.  And, that is just wrong.  No parent would tell their child that.  And, I don't think we should do things and make public policy that reinforces that negative message, that message that is, at its face, a lie, that someone's appearance is more important than who they are.

    DR. MILLER:  Thank you.

    MR. KELLY:  Thank you, sir.

    MS. RUSSANO:  My name is Jama Russano, and I am the founder of children Afflicted by Toxic Substances.  I was a child at 14 that received a silicone breast implant, in 1972.  I was born with a hemangioma tumor on my right breast and I never developed fully.  My left side was a little bit larger than my right.  I grew up in the '70s and I wanted to look like everybody else.  So, my mom, at age 14, took me to a plastic surgeon and he put in a silicone breast implant and said, you know what, the only reason that you would have to take this out is because you might develop a little bit larger on your left side than your right but, other than that, it will last you a lifetime.

    Six months later my right breast was like a baseball.  I went back to the plastic surgeon and they told me, you know what, that is just normal.  There is nothing wrong.  Just massage it a little bit; you will be fine.

    At 16 I started getting headaches.  I started having problems.  That breast implant remained in my body for 19 years.  I went to doctors.  I couldn't understand what was wrong with me.  I was finally diagnosed with systemic sclerosis.

    In 1989 I went to a plastic surgeon and I asked is there any way that this implant could be due to my health problems?  Oh, no; no, no, I don't think so.  I was diagnosed with systemic sclerosis.  I will give you a new, better implant, a new better silicone implant.

    I had the surgery.  Within months the implant fell into my armpit.  I got worse.  My health deteriorated.  I lost a high-paying job.  I couldn't take care of my kids.  My kids couldn't come up and hug me because of the scars.

    With all of those issues of dealing with young children, on top of all of that, I realized when the silicone issues started coming out what about my children?  Where are these studies?  The safety of silicone and breast feeding and pregnancy?  Are our children just anecdotal studies?  There are thousands.

    I decided that, you know what, this question needed to be answered.  I came from a manufacturing background.  Why weren't these questions answered?  They had 20 years to do this and they didn't.

    We started Children Afflicted by Toxic Substances and we had several main concerns.  One was a young girl getting implants.  We testified at saline hearings at FDA and we asked that young girls--if they were going to approve them, that they not be used under the age of 18.  A young girl cannot understand or comprehend this type of data.  Most normal adults can't understand it, and the data is not even half there.  They don't understand that when they have an implant put in they might lose sensation of their nipple; that they might not be able to breast feed later because their nerve endings were cut.  How do you tell that to an 18 or a 19-year old?  How do they understand that?  They don't.

    When it comes to reproductive issues, we have had many, many women who have complained and sent in questionnaires about infertility problems; about miscarriages.  And, when they got their implants taken out their problems got better.  They were able to have children.  Anecdotal?  Yes, you could say that.

    The ability for women to breast feed a child--in one study by the Hertz report, up to 64 percent of 42 women with implants were unable to breast feed compared to 7 percent of 42 women without implants.  This is the highest reported range in the literature, that having an implant may significantly affect the ability to breast feed.

    The health effects on children born to mothers with implants, concerning silicones and secondary chemicals, the catalysts, the benzine, the phalates, are we looking at that?

    It is so important that we understand and get MedWatch forms out.  We have tried.  We have collected thousands.  We have submitted many hundreds of MedWatch forms to the FDA and so far only 136 are reported by the FDA.  I know that number can't be right.

    As the director of CATS, we worked on a questionnaire with the FDA many years ago and, unfortunately, we didn't have the funds to be able to submit it to pediatric doctors or OB/GYN doctors.  We couldn't get funding.  Who is going to fund a children's foundation?  Our children are sick.

    I know I only have eight seconds, but this is a very important issue and I ask the Commissioner if I could just have another minute to be able to talk about the kids.

    DR. WHALEN:  That, unfortunately, is unfair to everybody else who wishes to speak so, I am afraid, you will need to sum up.

    MS. GILBERT:  Excuse me, I would really like to hear her testimony when it comes to children.  If we could just take one more minute?

    DR. WHALEN:  Are there any of the succeeding speakers who are willing to yield their time?  We will allow you 30 seconds and that is all we can allow.

    MS. RUSSANO:  I am going to quickly show some slides.  We had a number of children go to a doctor or specialist, an orthopedic specialist in the Midwest.  Each mother took their child and ask the pediatrician if their breast implants could be a cause of this rare bone deformity and the doctor told them no.  He did not report these to the MedWatch.  He didn't report it to the FDA.  He didn't write it in their health reports for the children.

    These children are one in two million, one in three million, and they have not been looked at.  They have not been studied.  I ask you, for the sake of our children, for the sake of our next generation, for the sake of your child, would you want to think about your child and what would happen to that child being exposed to this device that is leaking through your body?

    We need more studies.  We need fair studies.  We need studies by the NIH.  We need studies that are not manufacturer funded.  We need to come together as a group, as a society and take care of these kids.  They can't get health insurance.  Mothers are afraid to go to the doctors and say anything because their insurance company will drop them.

    I wish I had more time, but there are many, many children out there and there is plenty of evidence.  You know what, I have two boys.  My two boys have severe problems.  My young son had a bone cyst removed on his head, and I have about ten other kids that have the same thing.  So, I beg you, do not put these implants back on the market.

    MR. HAYTON:  I am Rodney Hayton.  I am the CFO of the National Silicone Implant Foundation.  I have paid for the complete expenses of this trip out of my own pocket.

    I know that Inamed says silicone implants don't cause disease.  That depends on your definition.  However, the impact of silicone implants varies from person to person according to leakage rate and personal immune system threshold.  Silicone overloads and damages the immune system.  Silicone allows a variety of atypical disease symptoms to develop.

    Silicone implants can harm infants because silicone crosses the placental barrier and goes into mother's milk, proven by what is referred to as the Scandinavian studies, funded by Dow well over quarter of a century ago, report number 39-89 Dow Corning research department, 1972.  I have provided a copy to the panel.

    In March, 1994, the FDA advised the Human Milk Making Association to screen for women who have or have had silicone implants.  The body tries to remove silicone with macrophages, nibbling off bits of the polymer chain.  Silicone is moved all over the body.  Wherever the macrophage is when it expires is where the silicone is deposited at these locations.  The body, through its wondrous chemistry, demethylizes the silicone which results in grains of sand all over the body.

    What has happened to some of these women with implants the SPCA wouldn't allow to be done to your dog.  A five-year old child does not need epidemiological studies to figure out "don't touch the hot stove."  They do not have to understand how and why.

    Actuaries for insurance companies know about silicone implants.  That is why Blue Cross and Blue Shield in Texas and other states will not provide insurance coverage to women with implants.  The Canadian FDA knows about silicone implants since Canada has socialized medicine and their actuaries know that silicone implant patients have a disproportionately higher morbidity and mortality rate as compared to similar women without implants.  United States centers of Medicare and Medicaid actuaries know the statistics because of women's health care and disability claims.

    Mme. Curie died of the effects of radiation toxicity from her experiments with pitchblende.  She discovered and separated uranium and radium from pitchblende.  This was back in the time when we did not know the dangers of radiation in the human body.  She died just the same.

    There have been silicone implants where the removed the shell was completely disintegrated.  What happens to these women?  We do not know because it has never been studied and researched.  It is illegal to inject silicone gel.  So, what is the difference between an injection and leakage?

    The manufacturers' own data shows a 35 and 45 percent complication rate after four years.  I have seen the complications first hand.  Not being a doctor, but being part of a support group, women have been fairly free to show what has happened to them.  Some of them just show pictures and that is downright disgusting.  How many lives have been lost or ruined from silicone in the body?  How many more before the FDA will step up to the plate to do the right thing without regard to financial gain?

    For those who plan to do so, I applaud you.  For those who do not, please step up to the plate also.  We need more longer, in-depth studies and a better product before approval so we do not ruin any more women's lives that may be mothers, daughters, sisters, wives, granddaughters.  I would hate to have eye surgery with a complication rate such as this.  The results are more devastating than to be blind but I would not even think about it.  Thank you.

    DR. KERRIGAN:  Good morning.  I would like to thank the General and Plastic Surgery Devices Panel for the opportunity to present today.  My name is Dr. Carolyn Kerrigan.  I am an officer of the Plastic Surgery Educational Foundation, and I am here today speaking for that organization.

    I am a Professor of Surgery at Dartmouth Medical School and Section Chief and Residency Program Director for Plastic Surgery at Dartmouth-Hitchcock Medical Center.

    In 1989 I wrote a report on polyurethane breast implants for the Ministry of Health of Canada, and in 1991 I testified for Surgitek at the FDA hearings on polyurethane covered silicone gel breast implants.  I have no current affiliations or conflicts of interest with any implant manufacturer, and the Foundation has paid for my travel to present at this hearing.

    In my full-time academic practice of plastic surgery, I am a salaried physician.  I do perform breast implant surgery, both for reconstructive and cosmetic reasons, and this surgery generates practice revenue for my multi-specialty clinic.

    The Plastic Surgery Educational Foundation represents the education, research and service arm of the American Society of Plastic Surgeons.  The Foundation, founded in 1948, has three main core purposes:  Education, research funding and international outreach and service.

    Critical to improving patient safety is continuing medical education of physicians.  The Foundation sponsors instructional courses and several annual symposia to provide in-depth review of safety and outcomes related to breast reconstruction and breast augmentation.  Learning opportunities in this arena have intensified since 1991.  The Foundation has also developed an innovative web-based outcomes data collection tool allowing for national benchmarking and comparison of an individual surgeon's outcomes against that benchmark.

    Our organization also monitors the scientific literature on breast implants.  This information is used to guide directed research projects in areas of identified concern and to support ongoing education of its membership.  A document summarizing the current literature has been submitted to the panel.

    Research, as sponsored by the Educational Foundation, includes both non-directed and directed research.  Over the past 13 years, the Educational Foundation has funded more than two million dollars in grants.  Many of these projects are related to aesthetic and reconstructive breast procedures.

    Our directed research studies are an important component of the Foundation's activities.  Our directed research policy does not allow any individual organization or corporate entity to direct or influence the selection, funding or design of any Foundation-administered study.

    In 1991, the FDA's call for the manufacturer's PMA for silicone gel-filled implants clearly identified the need for additional clinical research.  Consequently, the Foundation established a three million dollar breast implant research fund.  This focused effort, starting in 1991 and continuing to this date, has included 18 very specific projects to investigate multiple aspects of breast implants including autoimmune disorders, biochemistry of silicone gel implants, quality of life, device integrity, local complications, explantation and implant rupture.

    Eleven of the original 18 projects were acknowledged by the Institute of Medicine of the National Academy of Sciences in its 2000 report, "Safety of Silicone Breast Implants."  The IOM found, as most of you know, that women with silicone breast implants were no more likely than the rest of the population to develop cancer, immunologic diseases or neurologic problems.

    Building on members' positive response to directed research funding, the Educational Foundation took a giant step forward in 1994 and established the specialty-wide National Endowment for Plastic Surgery.  The goal was to create a perpetual funding source for research projects relevant to clinical practice and unanswered clinical questions.  One such project so far sponsored includes support of the Center for Implant Retrieval and Analysis, which determined and demonstrated the types of scientific analysis needed for each type of implantable device used by plastic surgeons.

    In 2000, the Foundation developed the National Breast Implant Registry for data collection on all implant types and procedures.  This has now evolved to a robust web-based data tool, with participation from more than 75 practices and over 5,000 women.

    Ten months ago the European Union mandated that its member countries implement breast implant registries by 2004.  Several countries have selected our National Breast Implant Registry as the model of choice.  The International Breast Implant Registry was thus formed to allow collaborative data collection and analysis between the U.S., European, South American and  Australian organized plastic surgery.

    In conclusion, our specialty has remained at the forefront of reconstructive and aesthetic surgery based on its commitment to education, innovation and sound clinical and basic science research.  The Plastic Surgery Educational Foundation is funding breast implant research to educate its membership, to ensure patient safety and improve patient outcomes.  The Foundation has been proactive in establishing the National Breast Implant Registry and has established significant international collaborations.  The Foundation believes that breast implants and informed choice offer health-related quality of life benefits for many women.  Thank you.

    DR. WHALEN:  Doctor, can I ask you a question?  You mentioned, midway through your presentation, that the corporations do not direct or influence what research the Foundation does.  Are you aware of any dollar amount contributions that Inamed may have made to the Foundation since 1992?

    DR. KERRIGAN:  I don't have any numbers at my fingertips.  Certainly, the substantial proportion of contributions to the saline implant research was through membership contributions.

    DR. WHALEN:  Are there corporate contributions?

    DR. KERRIGAN:  There are some, yes.

    DR. LI:  Dr. Whalen, I have a question for the speaker--Steve Li.  You mentioned that you support the Center for Implant Retrieval and Analysis.  Has this Center published any of their results anywhere?

    DR. KERRIGAN:  I believe they have.  We can get you those references.

    DR. LI:  Thank you.

    DR. MCGRATH:  Dr. Kerrigan, we were talking yesterday briefly about a registry.  Can you tell us a little bit about where you see this National Breast Implant Registry going, what this is, how it may grow or whether you intend to have it grow?

    DR. KERRIGAN:  We certainly intend to have it grow and develop in many avenues.  Right now the Registry is basically physicians reporting details of their surgery; types of implants they use.  As the numbers grow and we get more data, we will then be able to do an analysis and reflect.  It is very easy to add particular data fields so if there is a specific issue that we need to address, we can add that to the database.  Obviously, long-term we want to expand this so that women who go through this surgery have a chance to report on their outcomes and also their baseline health status before participating in this type of surgery.  I mean, it has huge potential.  It will take many years to grow but there is lots that we envision for it.

    DR. MCGRATH:  Are there any measures in place to protect the patients' privacy?

    DR. KERRIGAN:  It certainly would be HIPAA compliant.

    DR. CONANT:  May I ask a quick question?  What is the incentive to register your patient if there is a benchmarking that is a requirement?

    DR. KERRIGAN:  It is not currently a requirement.  It is currently voluntary.  But the development of this database and other web-based collection tools are very closely tied to some of the ongoing work by the American Board of Plastic Surgery which certifies plastic surgeons.  As many of you are aware, there is an initiative in place to bring on board maintenance of certification so that surgeons would have to continue to maintain some degree of certification, and this would be an obligatory participation, logging of all surgical cases you do which, obviously, then would include a subset of breast implant cases.

    DR. CONANT:  Any kind of auditing of one surgeon relative to the benchmark?

    DR. KERRIGAN:  Yes, I mean the tool is designed so that individual surgeons can reflect on their practice relevant to national benchmarks.  A group such as the American Board of Plastic Surgery would monitor how folks are doing, and if there are outliers, would have the capability to audit the practice.  This is what we hope is coming over the next five to ten years.  It is not there yet but that is part of what we envision.

    MS. GILBERT:  So, for the 5,000 patients you mentioned, is it accessible to patients?

    DR. KERRIGAN:  The Registry is currently not open to patients.  Those are some of the issues that we are addressing and would like to see it evolve to that.

    DR. WELLS:  Good morning.  My name is Dr. James Wells.  I am board-certified plastic surgeon and I practice in Long Beach, California.

    I am President of the American Society of Plastic Surgeons, the largest organization of plastic surgeons in the world.  On behalf of the 5,000 member surgeons, I want to thank you for the opportunity to present the perspectives of our organization.

    I have no affiliations or conflicts of interest with any implant manufacturer.  The Society has paid my travel.  I perform breast implant surgery as part of my practice.

    Breast reconstruction and breast augmentation are procedures that significantly improve the quality of life for many patients.  Both procedures give women a sense of normalcy.

    As a result of previous discussions with the FDA, the need for a document with photos which will fully inform the patient about risks and possible complications of surgery using silicone breast implants has been developed by ASPS, in cooperation with our sister society, the American Society for Aesthetic Plastic Surgery.  This is an example of such a document, and I believe you have it in front of you.  It includes a short quiz to validate the patient's understanding of the procedure which includes the risks and benefits.

    The choice of elective or reconstructive breast surgery has always been an individual choice for women.  Consultations may take 30 minutes to one hour to complete.  Most surgeons will continue to follow their patients indefinitely.  However, the satisfied patient without any problems is reluctant to return for routine follow-up.  This may account for the failure to obtain a higher percentage of follow-up sought by this panel.  Even the periodic manufacturer's payment to patients for follow-up is not a consistent inducement for patients to return in the absence of any obvious problems.

    Plastic surgery is often a series of progressive operations, following one another at intervals.  Breast reconstruction may require two or three procedures over a period of a year.  Are these reoperations?  Breast implant patients, other than reconstructive patients, may require some minor adjustments to achieve the perfection that they expect and the plastic surgeon hopes to achieve.  Many of these minor procedures are done under local anesthesia, at no charge to the patient with the expense absorbed by the physician.  In most cases, patients return to their normal activities in a very short time.  Are these reoperations?

    As plastic surgeons, we recognize that the public has come to expect perfect outcomes virtually all of the time.  How often do families insist that the plastic surgeon be called to the emergency room to sew up the simple lacerations, clearly within the capabilities of our emergency physician colleagues?  The breast surgery we perform is not different.  Patients and the public have come to expect perfection.

    Following this expectation of perfect, are we expecting or demanding that the breast implant achieve that same level of perfection?  Could it ever achieve that designation of being the perfect implant?  Or, is it reasonable to accept that, like all medical devices, it has its limitations, associated failures, needs for reoperations and, in some cases, is not indicated for all patients.

    ASPS believes that continued monitoring and tracking of these patients and devices should be part of the process.  An earlier presentation by Dr. Bruce Cunningham and Dr. Kerrigan outlined a concept and plan from an existing registry to accomplish this and we are prepared to work with the FDA and manufacturers to accomplish this, if this is the recommendation of the panel.  We are also interested in linking our new patient information document to the web-based registry and adding the follow-up patient satisfaction survey as a third component.

    The emotion of body image and its importance to all patients is what drives much of the demand for plastic surgery.  This includes the use of breast implants.  Every patient has a vision of themselves that may not be the same as others see them.  Once considered the domain of only the wealthy, aesthetic surgical choices are now available to all women.

    Unfortunately, the occurrence of breast cancer is age indiscriminate.  I can remember a 26-year old woman, faced with breast cancer, recently married, who was told she had to have a mastectomy.   She was devastated when she came to my office.  We agreed on a mastectomy, tissue expander and a gel implant.  That was almost 20 years ago.

    After her surgery, she was faced with a decision to have a child or not.  She consulted with me about that and, with encouragement, she and her husband had that child.  She was concerned she would not be here to see her child grow up.  She had the child. She beat the cancer.  She still has the same gel implant of almost 20 years ago, and I receive an annual Christmas card update.

    Should she have been denied a gel implant which helped her with a serious life decision?  The young woman with a totally male physique receives breast implants.  What emerges is a young woman, at a critical social time in her life, who now feels and looks like a young woman.  Was it wrong to give her gel implants after a long and detailed discussion?