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