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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tuesday, October 14, 2003

 

8:00 a.m.

 

 

 

 

 

 

 

 

 

Grand Ballroom

Gaithersburg Marriott Hotel

9751 Washingtonian Boulevard

Gaithersburg, Maryland

 

 

PARTICIPANTS

 

Thomas V. Whalen, M.D., Acting Chair

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. Newberger, 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., DR PH

    Barbara R. Manno, Ph.D.

    Mary H. McGrath, M.D., MPH

    Michael J. Olding, M.D.

 

FDA

 

    Celia Witten, Ph.D., M.D.

C O N T E N T S

 

PAGE

 

Conflict of Interest and Opening Remarks:

   David Krause, Ph.D.    7

 

Panel Introductions:

   Thomas V. Whalen, M.D.    10

 

Welcome Remarks:

 

    CDR Stephen P. Rhodes    16

    Dr. David Feigal    18

 

Open Public Comment

   Introductory Remarks:  Thomas V. Whalen, M.D.    20

 

Public Speakers

   Susan Scherr, National Coaltion

      for Cancer Survivorship    23

 

   Shery Henderson, Silicone Solutions Outreach    28

 

   Carolyn Kittle    31

 

   Elizabeth Anderson    34

 

   Arlene Nicole Cummings    37

 

   Michelle Colombo    40

 

   Dr. Thomas Joiner    42

 

   Susan Cunningham    45

 

   Anne Stansell    49

 

   Rosella Rust    51

 

   Kathy Pate    54

 

   Nancy Bruning    57

 

   Jill Fallows    63

 

   Elizabeth Santoro    65

 

   Evon Peterson    69

 

   Elizabeth Weber    72

 

   Ed Brent    73

 

   Dr. Bruce Cunningham    76

C O N T E N T S (Continued)

 

PAGE

 

Open Public Comment (Continued)

 

   Margaretha McGrail    78

 

   Gail Hamilton    80

 

   Audrey Moritz-Ciancutti    84

 

   Cynthia Teague    87

 

   Pamela Dowd    89

 

   Lisa Bordelon    92

 

   Jessica Forman    94

 

   Diane Fjelstad    98

 

   Dr. Frank Vasay    101

 

   Marcy Gross    104

 

   Dr. Marga Massey    109

 

   Carolyn Wolf    113

 

   Dr. Vicki Hofnagel, (by conference call)    117

 

   Virginia Gallagher, (by conference call)    121

 

   Dr. Mark Jewel          124

 

   Mary Ann Richards    127

 

   Lisa Bancarz    129

 

   Eileen Wright    132

 

   Lisa Lowenstein    134

 

   Kathleen V.F. Nye    138

 

   Betty Buikema    140

 

   Dr. Caroline Glicksman    143

 

   Dr. Edward Melmed    147

 

   Dr. Paul H. Wooley    152

 

   Nancy Gertner    157

C O N T E N T S (Continued)

 

PAGE

 

Open Public Comment (Continued)

 

   Dr. Eugene Goldberg    160

 

   Mindy Tapscott    164

 

   Kim Gandy, National Association for Women     168

 

   Mary Ann Ward    175

 

   Marlene Keeling, Chemically Associated

      Neurological Disorders    180

 

   Vanessa Rose Ferelli    183

 

   Connie Wasserman    190

 

   Dr. Sidney Wolfe, Public Citizen    193

 

   Judy Norsigian, Our Bodies, Ourselves    203

 

   Dr. Deborah Bash    208

 

   Kathy Keithley Johnson, Toxic Discovery    212

 

   Dr. Paul Weiss, National Endowment

      for Plastic Surgery    218

 

   Dr. Laurie Casas, American Society

      for Aesthetic Plastic Surgery     223

 

   Dr. Leroy Young, Aesthetic Surgery

      and Research Foundation    229

 

   Dr. Martha Burke, National Council

      of Women's Organizations    233

 

   Dr. Laurie Young, Older Women's League    237

 

   Christine Lozier    241

 

   Anne S. Kasper, Finding My Way    244

 

   Dr. Shawna Willey, American College

      of Surgeons    249

 

   Margaret Volpe, Y-Me    252

 

Regulatory Overview of Silicone Gel-Filled

   Breast Implants:

    Cilia M. Witten, Ph.D., M.D.    257

C O N T E N T S (Continued)

 

PAGE

 

Applicant Presentation

Inamed Corporation

McGhan Silicone-Filled Breast Implants

 

Introduction:

   Ronald J. Ehmsen, Sc.D.    264

 

Preclinical Studies Review:

   Thomas E. Powell    267

 

Clinical Studies:

   JoAnn M. Kuhne, MSN, RAC    295

 

FDA Presentation

ODE and Office of Surveillance and Biometrics (OSB)

 

   Introduction and Mechanical Testing:

        CDR Samie Allen    393

 

   Chemical Testing:

        Sam Arepalli, Ph.D.    399

 

   Toxicology Testing:

        David B. Berkowitz, Ph.D., VMD    405

 

   Clinical Data Overview:

       Sahar M. Dawisha, M.D.    413

 

   Statistical Testing:

        Telba Z. Irony, Ph.D.    439

 

   Medical Devices Surveillance and

      Literature Review:

        S. Lori Brown, Ph.D., MPH    448

 

   Postapproval Study and Labeling:

        CDR Samie Allen    465

 

Open Panel Discussion    489

 

Open Panel Discussion and FDA Questions    551

P R O C E E D I N G S

Conflict of Interest and Opening Remarks

    DR. KRAUSE:  Good morning, everybody.  We are ready to begin this, the 63rd meeting of the General and Plastic Surgery Devices Panel.  My name is David Krause.  I am the Executive Secretary of this panel and I am also a biologist and a reviewer in the Plastic and Reconstructive Surgery Devices Branch.

    I would like to remind everyone that we request that you sign in on the attendance sheets which are just outside the door.  You can also pick up an agenda, a panel-member roster and information about today's meeting out there on the table.  The information includes how to find out about future meetings, future-meeting dates, through the advisory panel phone line and how to obtain meeting minutes or transcripts.

    Before I turn the meeting over to Dr. Whalen, I am required to read two statements into the record.  One is the deputization to temporary voting status and the other is the conflict-of-interest statement.

    "Pursuant to the authority granted under the Medical Devices Advisory Committee Charter, dated October 27, 1990, and as amended August 18, 1999 I appoint Benjamin Anderson, Dennis Boulware, Emily Conant, Nancy Dubler, Ruth Lawrence, Stephen Li, Ellice Liberman, Barbara Manno, Mary McGrath and Michael Olding as deputized voting members of the General and Plastic Surgery Devices Panel for this meeting on October 14 and 15, 2003.

    "In addition, I appoint Thomas Whalen to act as temporary chair for the duration of this meeting.  For the record, these individuals are special government employees and consultants to this panel or other panels under the Medical Devices Advisory Committee.  They have undergone the customary conflict-of-interest review and have reviewed the material to be considered at this meeting."

    This is signed by Dr. David Feigal who is the Director of the Center for Devices and Radiological Health.

    The conflict-of-interest statement is as follows.  "The following announcement addresses conflict-of-interest issues associated with this meeting and is made a part of the record to preclude even the appearance of an impropriety.  To determine of any conflict existed, the agency reviewed the submitted agenda for this meeting and all financial interests reported by the committee participants.

    "The conflict-of-interest statutes prohibit special government employees from participating in matters that could affect their or their employers' financial interests.  However, the agency has determined that the participation of certain members and consultants, the need for whose services outweighs the potential conflict of interest involved is in the best interest of the government.

    "We would like to note for the record that the agency took into consideration certain matters regarding Dr. Miller.  He reported his institution's past and current involvement with firms at issue.  The agency has determined, therefore, that he may participate fully in the panel's deliberations.

    "In the event that the discussions involve any other products or firms not already on the agenda for which an FDA participant has a financial interest, the participants should excuse him- or herself from such involvement and the exclusion will be noted for the record.

    "With respect to all other participants, we ask, in the interest of fairness, that all persons making statement or presentations disclose any current or previous financial involvement with any firm whose products they may wish to comment upon."

    At this time, I would like to turn the meeting over to Dr. Whalen.

Panel Introductions

    DR. WHALEN:  Thank you, Dr. Krause.

    Good morning.  I am Dr. Thomas Whalen.  I am Professor of Surgery and Pediatrics at Robert Wood Johnson Medical School.  I would venture, based on my own experience this morning, there are others who are going to be at this meeting who are probably visibly aging waiting for the elevators to get down here because it takes so long, including some of our panel members.  So we would hopefully tolerate some of them coming in a little bit later than we had anticipated.

    Today, the panel will be making recommendations to the Food and Drug Administration on a premarket approval application.   Our next item of business is to introduce the panel members who are giving of their time to help the FDA in these matters and the FDA staff who are here at this head table.

    I would ask each person, starting at my left, to introduce themselves and for the panel members to specifically not only give the typical introductions with your names, institutions and titles, but to please give a very brief comment upon the area of expertise that you bring to this particular panel.

    Starting to my left, then, from the FDA with Dr. Witten.

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

    DR. MILLER:  I am Michael Miller.  I am a professor of plastic surgery at the University of Texas M.D. Anderson Cancer Center and I have worked with breast reconstruction and breast surgery and these types of devices for many years.

    DR. ANDERSON:  My name is Ben Anderson.  I am an associate professor of surgery at the University of Washington.  I am a breast-cancer surgeon.  I do not place implants but my patients do receive them and I am listening on their behalf.

    DR. LI:  My name is Dr. Steve Li.  I am the President of Medical Device Testing Innovations.  My areas of expertise are biomaterials, biomechanics and failure of medical devices.

    PROF. DUBLER:  I am 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.  My expertise is in medical ethics.

    DR. NEWBERGER:  I am Amy Newberger.  I am a dermatologist in private practice in Scarsdale, New York.  I teach at St. Luke's Roosevelt Medical Hospital Consortium in New York City.  My expertise is that I have along experience with various forms of silicone.

    DR. BOULWARE:  My name is Dennis Boulware.  I am a professor of medicine at the University of Alabama at Birmingham.  I am also a rheumatologist.

    DR. McGRATH:  I am Mary McGrath.  I am a professor or surgery at the University of California, San Francisco, and I am a practicing plastic surgeon, have been working with implants for almost 25 years.  My research interests are in wound healing and biomaterials.

    DR. LEITCH:  I am Marilyn Leitch.  I am a professor of surgery at the University of Texas Southwestern Medical Center in Dallas.  I am a surgical oncologist so I deal with patients having breast cancer and also breast-screening issues.  That is the expertise I bring.

    DR. CHANG:  I am Phyllis Chang.  I am an associate professor at the University of Iowa College of Medicine, Department of the Surgery in the Division of Plastic Surgery as well as in the Division of Hand and Microsurgery.  My expertise is as a reconstructive plastic surgeon.

    DR. CHOTI:  My name is Michael Choti.  I am an associate professor of surgical oncology at Johns Hopkins University and my interest is in clinical surgical oncology.

    DR. BLUMENSTEIN:  I am Brent Blumenstein, a biostatistician working independently.

    DR. CONANT:  I am Emily Conant.  I am an associate professor of radiology and Chief of Breast Imaging at the University of Pennsylvania.  My expertise is in detecting and diagnosing breast cancer with breast imaging.

    DR. LAWRENCE:  I am Ruth Lawrence from the University of Rochester School of Medicine and Dentistry, Professor of Pediatrics and OB-GYN.  My particular area of interest and expertise is breast feeding and human lactation, its impact on both the mother and the baby, and the breast and its function and purpose.

    DR. LIEBERMAN:  My name is Ellice Lieberman.  I am an associate professor of obstetrics and gynecology at Harvard Medical School and an associate professor of maternal and child health at the Harvard School of Public Health.  I am also Director at Brigham and Women's Hospital of the Center for Perinatal Research and my expertise is in epidemiology.

    DR. MANNO:  I am Barbara Manno.  I am from the Louisiana State University Medical Center in Shrevepoint, Louisiana.  I am professor in the Department of Psychiatry.  My specialty is toxicology.  I have been trained as a general toxicologist.  I have worked in poison-center activities from management down to answering the phones.  So I come to you with quite a few years in medical-toxicology support and my subspecialty is forensic toxicology.

    DR. OLDING:  My name is Michael Olding.  I am an associate professor of surgery at George Washington University in the Division of Plastic Surgery.  I have had a long interest in plastic-surgery devices in general and, in particular, breast reconstruction.  I bring that experience to this panel.

    MS. BROWN:  My name is Debera Brown.  I am the Vice President of Regulatory Affairs for Broncus Technologies.  I am the industry representative for the panel.  I have worked in medical-device development for over twenty years.

    MS. GILBERT:  Good morning.  My name is Alisa Gilbert.  I am the co-founder of the Unbroken Circle and Director of Office of Native Cancer Survivorship and the consumer representative today.  I am also a breast-cancer survivor of seven years and I have intimate experience with implants and this whole process.  So I am delighted to be here.

    DR. WHALEN:  I would like to thank all the panel members for their introductions and also thank them for the time they are giving these two days to help out the FDA.

    Also, because of the panel configuration going from Delaware to Virginia, you may need to not just raise your hand but speak into the microphone if you need get my attention at any time to ask questions or make comments, please.

    I would like to note for the record that the voting members present to constitute a quorum as required by 21 CFR Part 14.

    Next, I would like to introduce Commander Stephen Rhodes, the Branch Chief of the Plastic and Reconstructive Surgery Devices Branch who will make some introductory remarks.  Commander Rhodes?

Welcome Remarks

    CDR RHODES:  Thank you, Dr. Whalen, and good morning.  I am Stephen Rhodes, the Branch Chief of the Plastic and Reconstructive Surgery Devices Branch here at the FDA.  Welcome members of the panel, members of the public and manufacturers to this important two-day meeting of the General and Plastic Surgery Devices Panel, important  because it is the first FDA panel meeting to make recommendations on the approvability of a silicone gel-filled breast implant since 1992.  Tomorrow, you will make recommendations and vote on Inamed Corporation's premarket approval application.

    Because of the high public interest in silicone-gel-filled breast implants, in addition to the regular public-comment periods for any PMA discussion, we have scheduled eight hours for public comment on general issues related to silicone-gel-filled breast implants.

    After the public comment period this morning, Dr. Celia Witten, Director of the Division of General Restorative and Neurological Devices, will review the history of FDA's regulation of silicone-gel-filled breast implants.  Following Dr. Witten's presentation, Inamed Corporation will present the data in their premarket approval application followed by FDA's review of the application.

    While this afternoon's FDA presenters are in the Office of Device Evaluation and the Office of Surveillance and Biometrics, there are other offices in the Center for Devices and Radiological Health that are part of the FDA team and many are here today.  These include: the Office of Compliance who have evaluated the sponsor's manufacturing facility and audited the clinical-study data; the Office of Health Industry Programs who provide assistance to consumers and review the program labeling; the Office of Science; and Technology and the Office of the Director.

    Additionally, the FDA team consists of reviewers from the Division of Pediatric Drug Development and the Pregnancy Labeling team in the Office of New Drugs in the Center for Drug Evaluation and Research.  I also want to acknowledge the valuable assistance provided by the Office of Women's Health in FDA Headquarters.

    As a reminder, we will not be discussing saline-filled breast implants at this meeting and I request that panel members and the members of the public limit their comments and discussion to the products being evaluated, silicone-gel-filled breast implants.

    Panel members, we appreciate your commitment.  The representatives of 27 professional organizations and 92 members of the public who have requested time to address the panel, we appreciate your comments.  And, PMA sponsor, we appreciate your participation in presenting the safety and effectiveness data you have collected to the panel and answering questions that the panel may have.

    Thank you for your attention.  I would now like to introduce Dr. David Feigal, the Director for the Center for Devices and Radiological Health.

    David?

    DR. FEIGAL:  Good morning.  I would also like to extend my welcome here.  I wanted to take a moment to actually address a problem which we are trying to deal with.  We have heard for a number of years that it is very difficult for people who have medical devices to get notifications and information about these devices.

    It has been suggested registries could be used for such a mechanism but registries track individuals by name, must keep track of their addresses.  They are very labor intensive and beyond, really, the resources of the Center aside from any of the confidentiality issues and problems that that creates.

    What we have done in breast implants is a new program which we hope to extend to other medical devices where we will actually provide, through e-mail contact, information about products of great concern to the public.  There is a brochure that is out on the table that people can sign up and all that is needed is an e-mail name.  If you would like to also give us your name, that is fine, but we are not in any way tracking individuals.  This will be an opportunity where we can communicate with people who would like information about medical devices, about medical devices that they are using, about such products.

    So, for example, the summary of this meeting, the web pages where the transcripts may be found, other kinds of information about these implants will be provided as a part of the updates that would be sent by e-mail.  If there are organizations that would like us to load mailing lists and other lists of people who would like to participate in this and hear information from us, we can do that as well.

    One of the things that we particularly appreciate is the publicness of this process.  We realize that it is at some expense that people travel here.  It is certainly a commitment of people's time.  We value very much the perspectives that we hear from people who will put a face on the use of these products and we value, very much, your expertise in considering whether or not these products meet the standards for safe and effective products.

    So, with that, let me conclude my welcome and wish you a successful two days.

    DR. WHALEN:  Thank you.  We now will proceed with the open public hearing session of this meeting.

Open Public Comment

Introductory Remarks

    DR. WHALEN:  All those who will be addressing the panel are asked to speak clearly into the microphone at the podium as the transcriptionist is dependent upon this means of providing an accurate record of the meeting.

    I would specifically now like to have the attention of all those who are registered or who might be considering speaking to the panel today.  You have each, if you have registered, been given a number corresponding to your order of appearance.  We would ask that you come to the podium area in advance so that we are not spending a great deal of time in transitions from speaker to speaker due to the volume of individuals who will be speaking.

    FDA staff will direct you to the appropriate podium.  Please remain within your time constraints as we will have a timer going to help people remain on time and please be aware that you will receive a flashing light when 30 seconds remain in your allocated time.  If you go beyond that, I will try to, as unobtrusively as possible, remind you that you need to come to conclusion.

    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 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 information might include the sponsor's payment of your travel, lodging or other expenses in connection with your attendance at the meeting.  Likewise, FDA encourages but does not require you at the beginning of your statement to advise the committee if you do not have any such financial relationships.

    If you choose not to address this issue of financial relationships at the beginning of your statement, it will not preclude you from speaking, which is a departure from the last time I chaired a meeting a couple of years ago.

    We will start with those individuals who have notified FDA of their request to present in the open session.  I would tell you in advance, for those of you who will be lining up in your assigned order, that, at a particular point in time in mid-morning, I will be interrupting to take a break and then I also will be interrupting at a later point in early afternoon when we will be breaking for 45 minutes for lunch.

    If the first speaker would come to the podium, then, please.

Public Speakers

    MS. SCHERR:  Good morning.  My name is Susan Scherr and I am with the National Coalition for Cancer Survivorship.  There is no conflict of interest.  I have not received any funds.  This is a statement letter on behalf of twelve different organizations.

    To the members of the panel, the National Alliance of Breast Cancer Organizations, Y-Me National Breast Cancer Organization, the National Coalition for Cancer Survivorship and nine non-profit health and cancer organizations that share our concerns believe it is important that women requiring reconstructive surgery for because have silicone breast implants available as an option for reconstruction.

    Please note that we offer no opinion or comment on the availability and use of silicone breast implants for cosmetic or other purposes.  Consistent with the missions and expertise of our organizations, we are not endorsing products from any manufacturer and the following comments are limited to the availability of silicone breast implants for women with breast cancer, breast disease or other medical needs and by qualified clinicians.

    All of the undersigned organizations support the right of each consumer and patient to consider options for selection and then receive individualized treatment and care that follows the approach she or he desires and believes is best.  Furthermore, we encourage consumers to make healthcare decisions in consultation with an expert clinician after receiving and understanding in-depth information on the benefits, risks and unknowns and uncertainties of a range of state-of-the-art options for care.

    Consistent with these rights, we believe that silicone breast implants should be available as an option for women requiring reconstruction.  About 20 percent of patients with breast implants receive them because of a breast cancer diagnosis or other medical need.  Current options for post-mastectomy reconstruction are limited and not all are suitable or possible for every woman.

    For many women, an external prosthesis is impractical and saline-filled breast implants often cannot achieve acceptable symmetry, appearance or comfort.  We emphasize that, because women differ by health status and by emotional, physical and personal needs, they require a similarly wide variety of post-mastectomy reconstruction options.

    A further important distinction is that women with breast cancer who choose implants do so with a different risk/benefit analysis than those who choose implants for other reasons.  After breast cancer, most women with an implant consider it is necessary, not optional, or even crucial, for their healing and recovery.

    Despite the availability of implants over the past decade, in reality, it has been very difficult for women to get implants in controlled studies as many physicians are unaware of the studies or unable to offer them to their patients.  After an extensive review of the science surrounding breast implants, the U.S. National Academy of Sciences' Institute of Medicine reported there is no causal relationship between systemic illness and breast implants as these illnesses occur with the same frequency in women with breast implants and women without breast implants.

    The U.S. Federal Court's National Science Panel, the European Parliament's Scientific and Technology Options Assessment and the British Ministry of Health all reached the same conclusion.  In its recent report to Congress, NIH reported that a large meta-analysis following the IOM review of the literature concluded that there was no evidence of an association of silicone-gel-filled breast implants with connective-tissue diseases or other autoimmune or rheumatic conditions.

    Women should receive accurate information and give their informed consent regarding the risks and benefits of silicone breast implants.  No breast-cancer or any medical procedure is without risk.  Neither are medical devices which do not last forever.  These treatments and devices are not completely predictable or completely understood.  Silicone breast implants for reconstruction should not be held to a different, higher standard.

    However, we feel strongly that women considering silicone-gel-filled or any type of breast implants must receive current detailed and accurate information about the device's risks, benefits and complications including incidence of capsular contracture and rates of rupture.  In addition, we advocate ongoing data collection and reporting based on long-term follow up of all women who receive silicone implants for reconstruction.

    Follow-up mechanisms such as privacy-protected recipient registries and close physician tracking will be needed to facilitate medical professional education training and disclosure data compilation and analysis, regulatory oversight and prompt communication of significant findings to consumers, panels and providers.

    In conclusion, the undersigned twelve organizations recommend that the panel make silicone breast implants available for reconstruction use for women with breast cancer, breast disease or other medical needs.

    Do I have time to read the organizations?

    DR. WHALEN:  No; I am afraid that is the end of your time.

    MS. SCHERR:  Okay.  Thank you.

    DR. WHALEN:  Thank you for your comments.  Just two technical notes before our next speaker.  One is, apparently, the light does not flash at 30 seconds but simply turns yellow.  So you can be aware of that.  Or it will turn red at the end of your time.

    The other technical note for the audience, if you are in possession of cell phones or pagers, I give you three choices; silent mode, off or outside.  Thank you.

    The next speaker?

    MS. HENDERSON:  Good morning.  My name is Sherry Henderson and I am from Bossier City, Louisiana.  I came here today at my own expense with no conflict of interest.      I had fibrocystic breast disease and precancerous cells which resulted in a double mastectomy and reconstructive surgery with implants.  During my first year of the implants, I had chest pain and headaches.  Within the next three years, I had hair loss, muscle spasms, irritable bowel, reflux, chronic fatigue and rashes.

    By the eleventh year, a sonogram verified a silent rupture I had and I had my third surgery with a tram-flap. That was a six-hour surgery and the medical cost was $41,000.  I was fortunate to see a doctor who studied implanted women for over 20 years.  I was diagnosed with several diseases including lupus likeness, rheumatoid arthritis, fibromyalgia, myositis, organic brain syndrome, high blood pressure and autoimmune diabetes.  I am now on disability.

    I would like to ask the FDA to have the implant makers to do at least ten years of study and research.  They should be required to pay for a national implant registry and require all women in it to have yearly screening examinations for local and systemic complications.  Let unbiased researchers do the screening.

    The Inamed research shows very high complication rates and an increase in symptom-like fatigue in just the first two years after getting implants.  But to know the real consequences, we must have longer research.  Breast implants are not life-saving devices.  If they are not safe, they should not be approved.

    Like thousands of breast-implant women, I live in pain every day and I pray that my grandchildren and my nieces do not go through the pain that I have gone through.  The higher rate of brain and lung cancer, more suicides and the study linking implants to fibromyalgia are warning signs that silicone gel should be made less available, not more available.

    We are tired of all the suffering.  There are young women becoming 100 percent disabled and the government is finally coming after the manufacturers.  If the FDA refuses to approve this defective product, the implant makers should be better research and develop safe implants.

    In the past, the FDA ignored hundreds of thousands of adverse reports reported to them dating back in the '70s.  Breast-implant women have copies of these reports and would be glad to provide them for anyone to see.  These reports document horrible health problems and unbelievable complications with these devices.

    Please make the right decisions for the sake of women who trust your opinion and whose lives depend on your trust.

    Thank you.

    DR. WHALEN:  Thank you.  The first two speakers representing national organizations were each allotted five minutes, for audience knowledge.  The next set of speakers for some time will be individuals and each will be allotted three minutes.

    The next speaker, please.

    MS. KITTLE:  Good morning.

    DR. WHALEN:  You can take advantage of our setting it up and just go ahead and take a few extra seconds.

    MS. KITTLE:  What did you say?

    DR. WHALEN:  You can go ahead and start.

    MS. KITTLE:  Oh, I'm sorry.  My name is Carolyn Kittle.  I am from Shreveport, Louisiana.  I came here at my own expenses.  I have no conflicts of interest.

    I am here today to testify about seeing a loved one experience pain from breast implants.  I have two sisters that have had breast implants.  My younger sister had breast implants for cosmetic reasons.  After having two children, her breasts were sagging and her husband wanted her to have bigger breasts.  She was only 22-years old.

    She immediately starting having problems.  They became hard.  Five ruptured and she has had at least five breast surgeries.  Her health has deteriorated.  She has been diagnosed with chronic fatigue, fibromyalgia, muscle pain, MS and many strokes and white lesions on the brain.  She is only 46-years old and cannot work due to her pain and the MS.

    My other sister had fibrocystic disease and cancer cells, had to have a mastectomy with reconstructive surgery and implants.  She soon was debilitated by headaches, muscle spasms, muscle pain, irritable-bowel syndrome and reflux.  She had a silent rupture and three surgeries.  I have seen her go from a vibrant wife, other and professional to a woman coping with lupus, fibromyalgia, thyroid disease and autoimmune diabetes.  She has had three breast surgeries.

    I grieve to see both my sisters go through what they have gone through as a result of a product that, even today, has never been tested for long-term safety.  My sisters have to travel hours away from their home to be seen by a knowledgeable doctor to treat their medical problems.

    Inamed's own research shows very high complication rates and they only studied women for two or three years.  Just imagine what the data would have looked like if they followed the women for another few years.

    I am asking the FDA to please make the manufacturers study women for at least a few more years before considering approval.  If you approve the implants first and tell the company to continue to study afterwards, the FDA has no authority to make them complete the study and you see, from the company's study so far, they won't do more than required.

    The European Union, on September 1, 2003, has reclassified all breast implants from a moderate risk category to the highest risk category for medical devices.  Now is not the time to lower our standards here in the U.S.  Scientists have found breast-implant women have higher rates of suicide and are more likely to die from brain cancer and lung cancer compared to plastic-surgery patients who smoke just as often as implant patients do.

    The FDA's own study shows the risk of leaking implants and those leaking implants are difficult and very expensive to remove.  I urge the FDA to reject approval until further research and long-term data are available.  We need to know what implants do to the human body year after year.  I ask the advisory panel to the FDA to listen to all the ill women, make manufacturers do better research before you consider approval.

    Thank you and God bless.

    DR. WHALEN:  Thank you.

    MS. ANDERSON:  My name is Elizabeth Anderson and I come here from Florida at my own expense.  I have no conflicts of interest.

    Until last month, I was director of an on-line health hotline and I have spoken with hundreds of women who have had breast implants or who wanted to get them.  They wanted to know if implants were safe and if implants could make them sick.  Many wanted to have their implants removed but they either had no money for the surgery or needed to find a doctor who would take their problem seriously and who would treat them.

    Many of the women I spoke with were sick with problems ranging from mild to devastating.  While some got sick shortly after getting implants, most were fine for ten years after implantation and then they started getting sick at that point.

    Women told me they were suffering from multiple illnesses and of doctors who were unresponsive to any suggestion that their problems could have been caused by their silicone implants.  Their doctors sometimes told them that they were depressed and that was why they were so ill, but it seems more logical that, because they were so ill, they were depressed.

    When you hear so many stories of ruined lives, you understand this.  Some became so sick they could no longer work which, of course, meant the loss of income and health insurance.  Can you imagine believing the medical device you have chosen is perfectly safe and thinking you are going to feel better about yourself only to become so sick that you lose everything, even your spouse.

    I have spoken with numerous women who have gone through this and I know women in their 30s and 40s who are completely disabled from their breast implants.  I believe that women who have had mastectomies should have a choice for reconstruction, but what kind of choice do implants offer?

    There is no long-term reliable research proving the safety of breast implants, not the Mayo study, not the Harvard study, and not the IOM report that is based on them.  Epidemiologists will tell you that these often quoted are seriously flawed because so many women in them had implants for only a few months or years.  Diseases like scleroderma and MS take a few years to develop and to be diagnosed.

    Breast-cancer patients have suffered enough but, according to Inamed's data, these women will have more complications from their breast implants than those who receive implants for augmentation.  So not only does a woman have to worry about a recurrence of because but she has to worry if her breast implants are going to make her sick.

    I am sure everyone here realizes the only thing most people need to hear about a medical product is that it is FDA approved.  That is the seal of safety.  People believe the FDA protects them from untested and unsafe products.  To be approved, silicone-gel breast implants should be proven safe for long-term use by research on a large cohort over a long period of time, at the very least, ten years.

    The FDA is mandated to make decisions based on science but using all long-term research that is available is a hollow statement when there is no solid long-term research available.  Everyone knows that three years of research is not sufficient.  Since all Inamed's silicone-gel breast implantees since 1998 should have been enrolled a study, we should have at least a four-year study by now.  But, where is it?

    The study that Inamed started in 1990 could have been an excellent study but they neglected to include more than a few cancer patients and then most of the augmentation patients were lost to follow up making the study useless.

    DR. WHALEN:  Can you conclude, please.

    MS. ANDERSON:  Yes.  The FDA did not want to ban silicone-gel breast implants in 1992, allowed them to remain on the market to still be studied.  I ask, where are the data from those women?

    MS. CUMMINGS:  Good morning.  My name is Arlene Nicole Cummings.  I came here at my own expense and will not be reimbursed.

    At the age of 12, I had a benign breast tumor removed from my right breast.  This left me with an asymmetry problem that only got worse as I got older and had my children.  Fixing my breasts was something I had thought about for years.  After I was done having my children, I felt the time was right.

    I did a lot of research on line and found a great deal of information but nothing personal.  This is what prompted me to start implantinfo.com back in 1998 after I had my own surgery.  implantinfo is now the largest community website for breast-augmentation patients where women can read the pros and the cons about breast implants and go through photos and stories of thousands of other women.

    I am here today primarily because I am a satisfied breast-augmentation patient.  However, I never had the option of choosing silicone back in 1998.  After talking to women and doing my own research, I would choose silicone now over saline if it was available to me.

    On my website, I have corresponded with countless women who, for many reasons, probably should have had the silicone option but did not.  They were denied silicone implants, had an unsatisfactory result with saline, and then had a second surgery to replace the saline implants with silicone.  So they actually had to have two surgeries to get the result they wanted the first time.

    I am also aware of the frustration that surgeons feel because they can't give a patient what they know, in some cases, will produce a better result for them.  The risk of a second surgery, in my opinion, is far greater than the risk of silicone implants.

    Ironically, breast-cancer patients already have compromised immune systems but, for the most part, receive silicone implants.  Are they at less of a risk of the supposed risks of silicone implants?  I believe silicone implants provide a far better result for reconstruction.  If these patients get breast implants and get a better result with silicone, shouldn't they be available to all of us?

    Women, along with their surgeons, should be allowed to choose silicone or saline.  We are neither ignorant nor shallow and we are not seeking breast implants with informed consent.  We have researched the procedure for years.  The average age of a woman on my website is 34.  Most of us are married with children and just want to get back what we lost after pregnancy and nursing.

    I believe in informed consent and women should be told all the risks.  But, in the end, after we receive that information, let us decide, along with our surgeons, silicone or saline.

    I have passed out to a handful of testimonies from other women who, for many reasons, could not physically be here.  There are thousands more on implantinfo.com and I encourage you to read about them and give us back the choice of saline and silicone.

    I think you for your time.

    MS. COLOMBO:  Good morning.  My name is Michele Colombo and I come here on my own behalf and I have no conflict of interests,

    I am 34-years old and married.  For many years, I have been dissatisfied with the size and appearance of my breasts.  I am very self confident and I am an educated person but have always seriously considered improving my appearance by undergoing breast augmentation.

    I have been researching breast augmentation for approximately five years including reading the FDA website as well as other resources on the Internet.  In doing so, I have satisfied myself that silicone implants are a safe alternative for my breast augmentation.

    Unfortunately, in the early 1990s, silicone breast implants were banned for sale to people like me in the United States.  If I lived in Europe, I could get silicone breast implants.  If I traveled to Europe, I could silicone breast implants and come back to the U.S. and live here with them even though they are unavailable here.  If I had breast cancer, I could get silicone breast implants.  What's more, if I were a man, I could get silicone testicular implants and if I required a shunt for medical reasons, it would also be silicone.

    But, unfortunately, for me, I am just a woman seeking to undergo a cosmetic procedure.  Moreover, what I seek is a procedure using a product which has been shown in numerous studies to have no more long-term heath risks than saline breast implants or other silicone devices.

    My problem, it seems, is that the FDA, up until now, has viewed people like me as unable to decide what it best for me.  I could make that decision if I had cancer but simply because I want to improve my physical appearance, that is not enough to justify the risks, in someone else's opinion.

    I think it is time to reevaluate the true motivations for the ban in silicone breast implants.  The fact that breast-cancer patients may obtain them and cosmetic patients cannot exposes the true reason for the ban.  What is at stake is a moral judgement rather than a medical one.  If my breasts are completely deflated from breast feeding, weight loss or age, improving my appearance with breast implants is deemed unacceptable because it would be for vanity.  If I had had a mastectomy, it would be acceptable because it could be justified as medically necessary.  The difference is a moral one and not the a medical one.

    I urge you to remove the ban on simply breast implants and let women make informed decisions about their bodies the way millions of people do every day with countless other devices and medicines that are approved by the FDA.

    Thank you for your time.

    DR. JOINER:  Good morning.  I am Dr. Thomas Joiner, the Bright-Burton Professor of Psychology at Florida State University.  I have authored a peer-reviewed paper on the association between breast augmentation and suicide as well as six books and over 200 scientific articles on topics related to mental disorders including suicide.

    I was awarded a Guggenheim fellowship for research on suicide and was given the Schneidman Award for Excellence in suicide research from the American Association of Suicidology.  My travel expenses to this hearing were paid by the American Society for Aesthetic Plastic Surgery.  I have no financial ties to any implant manufacturer and no involvement in a pending law suit related to breast implants.

    I thank the panel for the opportunity to address the relation between breast augmentation and suicide.  To date, there are four studies indicating that women who undergo breast augmentation have higher suicide rates than women in the general population.  It is crucial to note that breast-augmentation patients are not representative of the general population and the ways in which they differ from the general population are very relevant to suicide risk.

    The crucial point it this.  Breast-augmentation patients should be at relatively high risk for suicide for reasons that have nothing to do with breast augmentation.  Given the demographic and other characteristics of breast-augmentation patients, their suicide rate should be higher than that of the general population.

    Consider race, for example; virtually 100 percent of breast-augmentation patients are white whereas the general population of women is, of course, more diverse.  This is relevant because white people are more likely to die by suicide than non-white people.  Breast-augmentation patients' risk for suicide is increased partly because of the simple fact that they come from a racial group with relatively high suicide rates.

    This same exercise can be repeated with the same conclusions for each of the following factors; age, marital status, alcohol use, personality and symptoms of mood and other disorders.  In each case, breast-augmentation patients appear to differ from the general population of women and, in each case, the difference is such that suicide risk is increased.

    I calculated the expected suicide rate in breast-augmentation women given their demographic and other characteristics.  A conservative calculation produces an expected suicide rate among breast-augmentation patients that exceeded the population rate by fourfold.  For reasons having nothing to do with breast augmentation, the subgroup of women who undergo the procedure should have relatively high suicide rates because their demographic and other characteristics put them at high risk.

    Given that expected rates are fourfold the population rate, and actual rates are lower in every study to date, the possibility arises that breast augmentation actually confers protection from suicide a possibility that squares with the finding that vast majority of breast-augmentation patients report high satisfaction with the procedure.

    A safe conclusion appears to be that actual suicide rates are no higher than and may possibly be lower than expected suicide rates among women who undergo breast augmentation.

    Thank you.

    MS. CUNNINGHAM:  Good morning.  My name is Susan Cunningham.  I came here at my own expense.  My biggest concern is that these implants do rupture and there is still no medical information on how to recognize a rupture and what to do about it.  It is a frightening experience to be so sick and not have a clue what is wrong with you.

    Many women cannot afford an MRI to check and, even if they find out their implants are ruptured, they don't have the money needed for surgery.  My own experience began after I had breast-fed both of my children.  I decided on implants and arranged for a consultation with a highly respected plastic surgeon.  I had concerns, but the surgeon said the implants would last a lifetime.

    I was fairly pleased with the results, but it didn't last long.  I began to experience loss of nipple sensation and numbness.  Then I experienced capsular contracture in the right breast which is very painful.  As the years went by, I was plagued with sinus and respiratory problems.  My health continued to decline.

    Finally, in 1993, I consulted my plastic surgeon.  As he wrote in his notes, "I reassured her concerning this and advised her to leave her implants in place unless there are further difficulties because they look very good."   My body was wracked with joint pain.  I was diagnosed with Raynaud's and suffered from constant muscle spasms.

    My breathing and chest pain were severely affected and I had been in the emergency room several times.  Finally, tests indicated remarkable changes in my immunological system characterized by an unexplained decrease in the total CD4 or helper cells.  I was getting sicker and experienced a fatigue so devastating that I would weep from the smallest effort.

    My concentration was zilch and I started having huge gaps in my memory like pulling out of my driveway and then wondering where I was going or what I was doing in the car.  It was frightening and it became worse.  Finally, I was forced to quit a career that I loved.  At this point, it became necessary to sell our family home.

    I sought out Dr. Feng whose practice was 120 miles away.  She informed me that at least one implant was ruptured.  They were removed in 1995, both ruptured, and I promptly noted relief in the chest pain I had been experiencing for years.  Within a few months, my bloodwork, which for many years had been abnormal, returned to normal except for IgE levels and a positive antihistone antibody which took an additional two years to return to normal.

    My overall physical condition has taken a few years to improve.  I still suffer from fibromyalgia-like symptoms although attacks are less frequent and of shorter duration.  At the ripe old age of 61, my mind is much sharper and my body much stronger than it was just a few years ago.

    Today, I live a far different life than I could have lived if it were not for ruptured implants and their devastating effects to my life.  I am on disability which was granted on silicone rupture and related problems.  It was a very black day for me to finally accept the fact that working is no longer an option for me.

    I am not looking for pity because I have been blessed with many other things in my life.  But, if there is anything I could do to help another woman to avoid these devastating effects of ruptured or leaking implants, then I must try.  That is why I am asking you to not approve silicone-gel implants until the company provides long-term safety data proving that leaking silicone and immune diseases can be avoided.

    The company's application for silicone-gel breast implants was rejected in 1991.

    DR. WHALEN:  Can you conclude please.

    MS. CUNNINGHAM:  Thank you.  They had twelve years to collect data but they only collected three.  They will only do better research if approval is denied until they do.

    Thank you.

    MS. STANSELL:  My name is Anne Stansell.  I came here from New Mexico at my own expense.  I am a breast cancer survivor.  I was diagnosed at age 39.  The doctors said I needed a mastectomy, radiation therapy and breast implants.  Implants were just part of the treatments.  No discussion.

    I trusted the doctors who I felt had just saved my life.  I didn't know there was no safety study of breast-cancer survivors with implants.  That had never been done.  I was all right for the first few years.  Then I became very ill.  I was diagnosed with Graves' disease, fibromyalgia.  My eyes were so dry that one of the retinas tore.

    My implants were taken out about two years later.  I had to fight with my insurance company to cover the removal.  Half of one of my implants was gone.  Where did the silicone go?  I don't know.  Even with silicone left inside of me, almost immediately, I began to feel better.  My family really noticed a difference even before I did.

    I am still recovering, but I can work some now.  I thought of my own experience when I heard about the Inamed study of breast-cancer patients.  I had many of the same local complications.  I can't even remember how many surgeries I suffered.  Silicone was found in my side where it migrated from a broken implant.

    Inamed cancer patients also had an increase in some autoimmune symptoms during the first two years.  I think my symptoms started at the third year or so so it is likely that those signs and symptoms will increase over time, just like mine did.

    It doesn't do cancer patients any favor to give them the kind of choice I was given.  The choice isn't a choice if it is not a safe choice.  Informed consent isn't possible if the physicians think the FDA approval means a safe product.  A recent NIH study shows a doubling risk of brain cancer and a tripling risk of lung cancer in breast-implanted women.

    Health Canada has now started a study in 1996 to determine the cancer risk in 40,000 breast-implant women who were implanted from 1974 to 1989.  This data should be available later this month.  It is outrageous to continue to allow the marketing of a device that may increase the risk of cancer in women who are recovering from breast cancer.       Your job is to look at the research, but I hope you will listen to the patients, too.  We illustrate the data.  We are the examples of what can and what has happened to tens of millions of women around the world.

    MS. RUST:  (Read by Beth Nichols.)  My name is Beth Nichols and I am reading this on behalf of Rose Rust who is too ill to be here today.  I have no conflict of interest.

    "My name is Rose.  I am 57-years old.  After I remarried in 1990, I thought I needed to look younger so I opted to get silicone breast implants made by McGhan, now called Inamed.  I had talked to a plastic surgeon and he told me they were safe and they would last my lifetime.

    "Within four months of getting the implants, I noticed I was aching all over and had headaches.  I went back to the surgeon and told him I thought they were making me sick.  He told me I was listening too much to the media and he saw no reason to remove them.  I believed him and left them in.

    "I became more ill and the headaches became almost unbearable.  I had so much pain that I had to quit my job.  I had become so ill that I was put on Social Security disability.  In the mid-'90s, my nasal passages started burning and my nose was swelling shut in addition to the horrible headaches.  My GP sent me to a neurologist who did many tests and sent me to an ENT.

    "I ended up having three sinus surgeries.  The three different doctors all told me that something was inflaming my nasal passages.  They told me that if I didn't find out what my body was reacting to, they couldn't help me.  I went to an allergist and he found no allergies.  We had our house checked for any toxins.  My husband checked our vehicles.  By now, I was feeling much worse, dizzy and nauseated.

    "Over the next few years, I went to many doctors including the Mayo Clinic, but nobody could find out what was wrong with me.  The last two or three years, I have become so ill I am almost bedridden.  My nasal passages burn all the time and my headaches are constant.  My legs and feet burn, swell and hurt so badly, I can hardly walk.  I am dizzy and nauseated.  I have lost much of my short-term memory.

    "Over the last few years, I have become intolerant of all chemicals.  When I am exposed accidentally, my nose swells shut, nausea and headaches worsen and my heart acts up.  In June of this year, I finally decided I was going to die if I didn't do something.  In August, I had my implants removed.  My left implant was ruptured and the plastic surgeon said most of the silicone had leaked out, migrating into my chest and into my lymph nodes.  She described it as 'a sticky mess.'

    "She also removed the lymph nodes with silicone in them.  At that time, she told me there was probably silicone in my liver, lungs and brain.  The right implant was intact.  I have no idea how long the left implant had been ruptured.  I saw no difference in how I looked.

    "Through the years, I have become unable to even take care of my home.  Sometimes, I am not able to fix meals for my husband.  I spend many days in bed.  Long ago, I gave up on social events.  My husband tells me I actually am much worse off than I realize.  It is just a struggle to survive.  If the doctors had not told me my illness was unrelated to my silicone implants, I would have had them out many years ago and perhaps avoided much of the silicone leakage.

    "I think of how, in 1991, the FDA decided not to take silicone-gel implants off the market.  It sent the clear message that silicone-gel implants are probably okay.  I feel many of us have been the guinea pigs and I feel we have proven that silicone is not safe because the implants can leak throughout our bodies.  It is too late to do much for women like me, but let's please save the next generation.

    "It is your responsibility to protect us and hopefully you can restore my faith in our FDA.

    "Thank you."

    MS. PATE:  Hello.  My name is Kathy Pate and I would like to thank the panel for the opportunity the speak today on behalf of silicone breast implants.  I am a registered nurse in Albany, Georgia and I work in an operating room there.  I have never had any financial relationship with any medical-device corporation or their competitors.  I am here representing myself and I have paid my own way.

    I have breast-augmentation surgery in December of 1983 because I had difficulty buying clothes to fit.  As many other women have stated, after I breast-fed my baby, I didn't have very large breasts to start with and then, after that, the problem was even worse.

    I became quite frustrated with this problem so I decided to have breast-augmentation surgery.  At that time, the quality of saline implants was very poor.  The possibility of deflation was very high.  At that time, also, there was no discussion about the serious complications related to silicone implants when I had my surgery.

    My plastic surgeon did tell me that there were possibilities of localized irritation if the gel ruptured.  He also said there was a possibility of capsular contracture.  I went ahead and chose the gel because they looked more natural and they were lighter.

    When the media put out the information on silicone implants, and they were removed from the market in the early '90s, I wondered what should I do.  Should I have them removed?  What should I do?  So I pondered the thought and decided that the best thing to do was see if anything developed.  I have not developed any problem with silicone implants and really have no concerns about their safety.

    I monitor my breasts with visual and physical exam and I have an annual mammogram.  I stay in close contact with my plastic surgeon and we decide we would monitor for any changes in shape or consistency to detect an early rupture.

    I realize there are risks associated with all types of surgery and especially with any implantable device.  Although it has been twenty years since my surgery, and I am sure at some point I am going to have to have those replaced, I would definitely do the same procedure again and I will go back to silicone.

    I believe firmly that women should have the option to choose saline or silicone and that they should have the risks and benefits outlined for each.  The individual receiving the product needs to have confidence in the product, itself, and also in the surgeon who is performing the procedure.

    I believe women who are well informed will make the decision that works best for them.  Given all the research and investigation of these devices, I feel certain that the product has been vastly improved to resist rupture and prevent complications.  Breast-implant surgery has allowed me to be comfortable buying clothes and not reduced to buying bras with heavy padding to fill out my clothes, and even bathing suits.

    The real message I want to convey here is that I feel like the women need to have a choice and be informed of the risks and benefits and have the option to choose.

    Thank you.

    MS. BRUNING:  Good morning.  My name is Nancy Bruning and I have no conflicts of interest.  I was told I had six minutes.  Can I have six minutes, five minutes?

    DR. WHALEN:  You are here with Ms. Peterson?

    MS. BRUNING:  Bruning.

    DR. WHALEN:  I know your name is Bruning.  You are listed as being here with Ms. Peterson.  That is why the two of you together were given six minutes.

    MS. BRUNING:  I see.  Well, I am wearing three hats, so--thank you.

    I am wearing three hats.  I am here today as a breast-cancer survivor.  I am here as the author of a book about breast implants that is currently in its third edition.  And I am here as a graduate student completing her Masters degree in public health.

    I became interested in breast implants because of my own experience with breast cancer and its aftermath.  You would probably never suspect it to look at me or to hear me, but I have had my chest cut open seven times, twice for breast cancer and five times to fix what the breast-cancer surgery wrought on my mind and body.

    My most recent surgery was to remove the gel implant that had ruptured along with the entire scar capsule that surrounded it, and it was replaced with a saline implant.  I am here to tell you that, although this could be dismissed by some as merely local complications, this surgery caused me more pain and disability than any of the other surgeries including the mastectomy.

    I am here because, if I had to do it all over again, you would have to tell me that, based on the studies that exist including the new Inamed study, breast-cancer patients have a very high probability of these things happening including a 46 percent chance of reoperation in the first three years.

    But can you tell me what the rate might be down the line?  No; you cannot.  I am here because, if I had to do it all over again, I would like you to tell me the odds that any silicone that escaped the scar capsule will cause systemic disease down the line.  Can you do that?  No; you cannot.  Can you tell me the odds of that happening with the new Inamed implant?  No; you cannot.

    The subtitle of my book is Everything You Need To Know About Implants and one of the first things I tell my readers that they need to know is that we don't know everything.  Far from it.  This was true when I first wrote the book in 1993 and it is only a little less true now.  And what we do know is not good.

    During the process of writing and twice revising the book, I interviewed scores of plastic surgeons, breast-cancer survivors, implant patients, researchers and advocates.  The one thing that is clear is that silicone breast implants were sold to almost 1 million women before any research on women was published in the peer-review journals.

    Currently, over a quarter of a million American women have breast implants every year.  This could be a disaster waiting to happen if silicone implants become available without proper long-term study.

    We now know that silicone-gel implants break after about ten years, on the average.  We now know that leaking silicone can migrate to the lymph nodes, lungs and all throughout the body.  We know that, in several studies, women with breast implants were more likely to die from certain types of cancer.

    And we know that, in three studies, women with silicone implants are three times as likely to commit suicide.  In the Inamed study, quality of life, including social interactions and self esteem, actually declined within two years of getting their implants.  This certainly raises questions about whether implants make women feel good about themselves as promised.  Results amy be even worse than the studies indicated.  Let's remember that most women do not like to admit mistakes or to criticize their doctors to their faces.

    Regarding the research conducted by Inamed, in light of what we know already, I wonder why they thought two or three years of research was enough.  Although the diagnosed rupture rate was low, 6 percent after three years reconstruction, we must assume that they are higher since three out of four ruptures are not apparent without an MRI.

    If you share my concerns that only half the breast-cancer patients were followed for even three years, especially since Inamed has been selling gel implants to cancer patients since the late 1990s.  Breast-cancer patients deserve better.  I am the living proof that they are living long lives.

    We deserve implants that don't result in additional surgery for 46 percent of us in the first three years.  We deserve long-term studies that can provide accurate information about the risks of developing serious implant-related health problems.  We deserve to have a choice.  Unfortunately, we do.  Most breast-cancer patients can now choose lumpectomy, saline implant, silicone-gel implants or autologous construction.  Choice is good but we deserve to have safe choices.  Silicone implants should only be approved if they are proven to be a safe choice for all women.

    If there is a problem with the way studies are conducted and there is a problem with recruitment and compliance, then the answer is to fix that, not to make silicone-gel implants available.

    Since I received my diagnosis of cancer over 23 years ago and experienced the first inklings that breast implants were not as safe as I was led to believe they were, I have been living with two kinds of uncertainties.  One, will I get breast cancer again and, two, will my implant cause me harm?  I have seen studies that address the first question.  Where are the good studies that address the second?  Inamed has not provided them for the women who currently have silicone-gel implants or for the millions more who would if the FDA approves them.

    I have suffered more than enough and don't want other women to follow in my footsteps.  We deserve to have better science than the implant companies have given us and it is your responsibility to use your power to make sure that they do just that before approval because it won't happen afterwards.

    Thank you.

    DR. WHALEN:  Just to make it clear to the other speakers, to make sure that everything seems fair, the reason somebody would have six minutes as opposed to three is because two speakers who have preregistered with FDA have combined their time and one of those two individuals is addressing us.  So, if you are wondering why you only have three and somebody has six, that is the reason.

    MS. FALLOWS:  Good morning.  My name is Jill Fallows.  I am a nurse as well as an attorney.  I do not have any financial relationship to Inamed or any of its competitors and, as a note of levity, as a trial attorney, I rarely find myself speaking before a group of such receptive physicians.  I am appreciative of the opportunity.

    I will address the issue of choice this morning.  It seems as though Inamed has framed its pro-silicone-breast-implant argument in terms of a woman's right to choose the device.  But simply offering a woman the right to choose is a far reach from providing relevant, unbiased, sound medical information upon which a reasonable woman can make an informed choice.

    It is irresponsible to argue that a woman is entitled to choose a medical product while simultaneously glossing over the relevant safety data in the device's promotion and labeling.  We want women to have choices.  But we have learned from the Dalkon Shield and DES that they are not safe products and should not be offered to women simply because we cherish the notion of an individual's right to choose.

    This is particularly true at today's meeting because the silicone-gel breast implant does not purport to relieve the discomfort or pains commonly associated with diagnosed illnesses and conditions.  Indeed, we don't want to offer women a choice of an implant knowing that it could rupture and leak silicone gel into their lymph nodes, lungs and other body parts where it cannot be removed.

    We don't want it leaking into their breasts so that removal results in a mastectomy to remove silicone rather than cancer.  We should be mindful that breast augmentation is a completely elective cosmetic procedure and the risks to the patient should be clearly outweighed by its benefits.

    We need to empower women and their physicians with adequate, accurate, unbiased information broad enough to address the diversity among the 50 states informed-consent laws and yet specific enough to affirmatively warn women that they are buying a product with a litany of known serious risks.

    We take, as a starting point, the notion that a doctor or a patient must be apprised of information upon which a reasonable person can rely and make an informed choice about the safety of the implant.  It would not be reasonable to minimize or hide the risks from the physician or the patients.  The manufacturer's product literature should especially make mention of the rate of risks of complications and a black-box warning would be minimally acceptable if it stated that the manufacturer has not adequately completed five-year safety studies.

    I am most appreciative your time.  Thank you.

    MS. SANTORO:  Good morning.  I drove here on my own expense and have no conflicts of interest.  My name is Elizabeth Santoro.  I have been a nurse for three years and I recently received a Masters of Public Health from Johns Hopkins.  I will be discussing problems with data quality.

    A major area of debate is whether silicone breast implants cause autoimmune diseases such as scleroderma, lupus, rheumatoid arthritis and fibromyalgia.  In 1999, the Institute of Medicine reviewed the 17 studies available at that time and found that most research found no significant link.

    A year later, a meta-analysis of the same studies agreed with that if the largest study by Hennekins, et al., at Harvard was excluded.  If the Hennekins study was included, there was a significant link between implants and these diseases.

    I would like to highlight some of the flaws in the studies that were both in the IOM report and the meta-analysis.  First, not all the studies were published in peer-review journals.  Second, many of the studies were based on hospital records.  This is problematic because a lot of people who suffer autoimmune diseases are not hospitalized for symptoms such as pain and fatigue.  Therefore, data from hospital records will not identify them.

    Medical records were also used as a primary source of information instead of a comprehensive medical exam.  The absence of a medical exam creates the opportunity where  valuable health indicators of adverse events can be missed.  Often, vague and nonspecific symptoms can be present in the beginning of an autoimmune process.  As a result, medical records may not be the best way to detect this class of disease.

    Most of the studies also included women who had implants for a very short period of time.  Autoimmune diseases can take at least five to ten years to develop.  So, including women with implants for only a few months or years cannot accurately capture all of the autoimmune diseases that might develop.

    I would also like to comment on the importance of sample size.  Many of these studies had women with just a few hundred.  That does not sound bad but a larger sample is needed when rare diseases such as scleroderma is being assessed.  The research that has been conducted in the past and reviewed by the Institute of Medicine is not sufficient to draw conclusions about the safety of breast implants regarding autoimmune disease.

    And, by the way, those studies did not look at morbidity and mortality from other causes or from disorders that were not diagnosed diseases and therefore are useless for drawing any conclusions at all regarding cancers and other disorders.

    Also remember that the first Institute of Medicine on Agent Orange found no link to cancer.  The first Institute of Medicine report on Gulf War veterans found no link to illness.  Subsequent research found clear evidence of statistically significant increased risk of serious diseases that were not apparent to the IOM in their first analyses.

    I would also like to note how the data that was made available by Inamed is suggestive of a connection between silicone implants and autoimmune disease.  Upon reviewing these data, FDA scientists found an increase in muscle pain, joint pain, hair loss, rashes and fatigue within two years of patients getting implants.  During this same two-year period, it was also found that many patients reported decreases in both physical and emotional health.  These signs and symptoms are characteristic of several autoimmune diseases in their early stages.

    In addition, FDA scientists noted previous studies found an excess of some cancers and leukemia among implant patients.  These studies were published after the IOM report.  The fact that implants may delay cancer detection via mammography is also troubling.  Moreover, the FDA's own study found that silicone implants break within about ten years often with no warning signs and the clinicians and pathologists have reported numerous cases where silicone gel had migrated to the abdomen, groin, fingers and axillary lymph nodes.

    These findings raise grave questions about the safety of silicone-gel implants.  They provide evidence that Inamed's implants are associated with many serious complications and declines in both physical and emotional health status even within the first two years.

    The data supplied by Inamed, combined with the limitations of the studies in the IOM report, show that there are many unanswered safety questions in regard to silicone-gel breast implants.  As a result, they should not be approved by the FDA.

    Thank you.

    MS. PETERSON:  (Read by Jennifer Brooks.)  Good morning.  My name is Jennifer Brooks.  I am reading testimony for Evon Peterson who cannot be here today due to an illness.  She has no conflicts of interest and neither do I.

    "My name is Evon Peterson.  Ten years ago, my silicone-gel implants were removed.  I was an R.N. and had implants for reconstruction for following bilateral mastectomies.  The doctors acted as if reconstruction was a given, something I should do.  It wasn't presented as a choice.

    "When I was explanted in 1993, the right implant was found to have ruptured and the left implant was severely leaking.  Three additional surgeries in 1994, 1995 and 1996 followed to remove bilateral siliconomas.

    "The first symptoms to appear after implants were the first to resolve or diminish when the implants were removed.  A few weeks after reconstruction--what an oxymoron that is--the firmness and contractures began.  The shape of my breasts became distorted and the surrounding tissue became inflamed.  Lying on my right side or freely using my right arm was restricted.  Searing pain invaded by back and neck.

    "After that, more obvious systemic symptoms developed.  By 1989, at age 45, I was totally disabled in my work and personal life.  I experienced profound fatigue, insomnia, seizures, tingling and numbness of extremities, dizziness, nausea, skin discoloration and hardness, migrating joint pains, chemical sensitivities and balance disturbances.  I felt like I was in a mental fog.  I had contemplated suicide as an option to stopping the pain.  I know if I had kept the implants in any longer, I would have committed suicide.

    "One of the worst aspects of this experience has been in the continuing denial of manufacturers and the medical community.  They fail to study implants and their related complications over a long period of time and then arrogantly claim that the products are safe for long-term use.

    "Prior to explantation, I faced a paradox.  I was too ill to have surgery and too ill not to have surgery.  I am glad that, on the recommendation of three of my many physicians and also based on my increasing knowledge, I chose to improve the quality of my life by removing my implants.

    "Despite living with multiple autoimmune processes and complications, my health has improved from about 10 percent functioning to 60 percent functioning.  Considering that I have also aged ten years, I am delighted.  I remain convinced that, had I not been explanted, I would have died within the year.

    "I am unable to physically present today because of pneumonia.  However, I petition you to require unbiased long-term studies before any decision is made about approval.

    "Thank you."

    MS. WEBER:  Good morning.  My name is Elizabeth Weber.  I live in Southern Maryland and I was not paid to come here today.  The opposite is true.   I asked to come today to share my story.

    My mother had breast cancer and had a bilateral mastectomy.  I, too, had a bilateral mastectomy in June of 1999.  I was aware of the controversy of silicone breast implants and, therefore, opted for the saline implant.  I am a very active person.  I trained for the Olympic Games since age of nine in the equestrian sport.

    Pain and perseverance is not new to me.  The saline implants were very uncomfortable to me.  Dr. Scott Spear did a wonderful job of my reconstruction and the outward appearance of the saline implants looked good, but I hated the way they felt inside.  They were hard and hurt from the inside.  I felt like I had a mass pushing against my chest.

    I stopped doing the sports I used to do and it was hard to sleep at night.  One year later, I went to Dr. Scott Spear and asked to have the saline implants changed and replace by silicone implants.  After I woke up from my surgery, I could feel such a huge difference.  After I healed from the surgery, I felt like myself, a whole, natural and complete woman.

    The outward appearance was impressive and beautiful.  But, even better, my breasts felt like mine from the inside.  I now do everything I used to and more.  I hope you give other women the same choice.

    Thank you for your time.

    ED BRENT:  Good morning.  My name is Ed Brent and I have received no funds nor do I have a sponsor that has helped me to fund this trip.

    Three years ago, my wife stood before you and did her best to convince you, the FDA, not to allow saline breast implants on the market.  My wife had double-lumen implants, my daughter, Catherine, leg braces, and that was because of the silicone implants, carried one of my wife's implants to your table showing the black fungus growing inside of it.

    My wife was P.J. Brent.  You may have seen her on CNN or other t.v. networks discussing breast implants.  She was distraught after being here and learning that everything that she had said was anecdotal evidence and not to be considered by the panel.  We were here March 1, 2000.

    On May 29, 2000, my wife committed suicide.  She left behind seven children and I am here on behalf of my wife and children to urge you not to allow silicone breast implants on the market.

    There are three studies showing that women that breast implants are more likely to commit suicide compared to other women.  Some experts think that these suicides mean that women with breast implants have lower self esteem before they got their implants as well as after.  But the National Cancer Institute study, which compares implant patients to other plastic surgery patients, shows that the problem is more likely to be from the implants.

    My wife was not a woman with low self esteem.  She was a vibrant, loving wife and mother.  P.J. loved the way she looked the first few years after the implants.  Then she started to get sick.  Her joints hurt.  Her fingers would swell so she could not wear her rings.  She did not know what was happening and sought medical help.  She had lupus-like symptoms and was diagnosed with fibromyalgia.

    She was explanted in 1992.  P.J. breast-fed the two daughters she had after the implants.  Catherine was born in 1985 and was diagnosed with chronic inflammatory demyelating polyneuropathy, CIDP, as well as esophageal-motility disorder.  She spent years in leg braces to allow her to walk.  Now, the braces are gone and have been replaced with a wheel chair and she has a special car with hand controls to help her drive.

    Christine was born in 1986 and also had esophageal-motility disorder and signs of the neurological disorder.  After P.J. committed suicide, an autopsy was performed from her.  Samples were extracted.  Large amounts of platinum were found in her body.  This came from the silicone.  The high platinum levels, a doctor at CDC saw them and said, "No wonder she committed suicide.  She could not have been in her right mind."

    Hair, nail and tissue samples were taken from our daughters who breast fed and it was found that they, too, had elevated platinum levels.

    You have an awesome responsibility before you, a responsibility of conscience and doing what is right for the women and yet unborn children of these women who may be forever affected.  Don't let this be a money issue, but a moral issue.

    Thank you.

    DR. CUNNINGHAM:  Good morning.  My name is Dr. Bruce Cunningham.  I am Professor and Chair of Plastic Surgery at the University of Minnesota.  I am speaking as an individual and have personally paid my way for the appearance today.  I own no stock in any implant manufacturer and receive no compensation of any kind.

    I have, however, received peer-reviewed research grants from implant manufacturers and I have served as a medical director of a PMA breast-implant submission.  I do use implants in my clinical practice.

    ASPS has recognized and acted on its responsibility to plastic surgeons and their patients.  The American Society of Plastic Surgeons has already established a breast-implant registry within a larger outcomes data-collection activity.  I worked on the development of TOPS, or Tracking Outcomes in Plastic Surgery, which collects plastic-surgery procedural data and clinical outcomes and can include collecting satisfaction data from patients, themselves.

    A breast-implant registry is embedded within the Internet data-collection tool of TOPS and can track things such as the number of implants placed or removed, clinical indications and type of facility, anesthesia and short-term complications.  NBIR, or the National Breast Implant Registry, was designed to allow physicians and their highly mobile patients to track implanted and explanted devices.   NABIR was, in fact, so successful in its design that it attracted international interest.  It has served as the template for IBIR, the International Breast Implant Registry, which is poised to become the standard for the European community, Australia and South America.

    In the initial piloting phase of NBIR, this data-collection tool over the Internet, 9,000 surgeries were recorded including 14,912 implants and 2,084 explants.  TOPS and NBIR, however, are hindered in their ability to provide benefit for patients and physicians by the stringent confidentiality constraints of HIPAA.  They could be improved significantly to provide transparent tracking of devices, surgeon records and implant-related events.

    To do this, however, the breast-implant registry that we have established requires public-health authority status as a part of a Governmental Health Operations Act.  The management, government and composition of the leadership of the NBIR could be changed to reflect the involved stakeholders by including the FDA, the public and industry representative members.

    Finally, TOPS could be enhanced to provide an interactive on-line patient-information and education process that could be linked, in turn, to verification and documentation of patient informed consent.

    In conclusion, ASPS, the American Society of Plastic Surgeons, is dedicated to providing the gold standard of outcomes data to benefit patients, the public and the profession.  We look forward to a partnership.  TOPS and NBIR can become a valid method for a registry to trace implant-related data and outcomes.

    Thank you for the opportunity to present.

    MS. McGRAIL:  Hi.  My name is Margaretha McGrail and I am not being compensated or paid in any way to be here.  I live locally.

    Four years ago, I made a decision to have breast-augmentation.  It was a personal choice.  I didn't need the surgery.  Years of running and age had caused my breasts to sag and shrink and it was affecting my self-esteem.  Someone referred me to a local surgeon who specialized in breast reconstruction and I went in to speak with him about possibly having the procedure.

    After talking with him, I decided the procedure was harmless and that it was worth going forward with.  While discussing the procedure with my doctor, my doctor mentioned that there was a study taking place that I could participate in if I wished.  It involved the opportunity to have silicone implants rather than the typical saline implants.

    He explained that silicone implants were much more natural looking and feeling than the saline.  Remembering vaguely that there had been some issues with silicone implants, I asked him about the hazards of silicone implants.  We discussed the pros and cons of silicone and I was given a couple of articles about the topic.

    My surgeon felt it was a very safe procedure.  It was my understanding that silicone implants had significantly improved over the years, that leakage was no longer an issue and that the past problems had been due to leakage.  The articles I had been given were very positive and the benefits of my taking place in a study seemed to outweigh any possible problems.  The study provided for regular checkups, periodic MRIs and I thought that was a benefit.

    I opted for the silicone implants.  I can attest to the fact that silicone implants are, indeed, dramatically more natural looking and feeling than the saline implants.  I have had no problems at all these past four years.  I have been extremely happy about my decision to have breast-augmentation.  I am very health conscious and take very good care of myself.  I believe in a preventative and holistic approach toward my health, so the issue of possible problems with silicone implants is a concern of mine.

    I would do nothing knowingly to jeopardize my health.  I have only had the implants for four years, so I cannot address the potential for problems after ten or fifteen years.

    MS. HAMILTON:  (Read by Elizabeth Curtis Hamilton.)  Good morning.  My name is Elizabeth Curtis Smith and I am here of my own will and I am reading the testimony of Gail Hamilton who was too sick to be with us this morning.

    "My name is Gail Hamilton.  I got silicone implants when I was 24-years old.  I had had two children and was very disappointed with my appearance after nursing.  I was slim and healthy and was told by the plastic surgeon how wonderful these implants were and how they would improve my appearance and they would last a lifetime.

    "Ten days after augmentation, the wounds opened up and there was no appreciable healing.  The implants were removed along with very large blood clots.  The implants were cleaned and reinserted.  This time, the wounds healed.  My body formed scar tissue around the implants causing them to feel like baseballs.

    "Seven years after my initial surgery, the implants were removed.  The troublesome scar tissue was taken out and the same implants were reinserted.  By 1989, I was experiencing very uncomfortable pain in my right breast and visited the plastic surgeon again.  He could find nothing wrong so I went home and tried to ignore the sore area under my right breast.

    "In the summer of 1993, I started to feel a burning sensation behind the implants against my chest wall.  It started with one side and the other one soon followed a couple of weeks later.  The burning became worse and worse every day and I went back to the plastic surgeon again.  I told him of the burning and how I was experiencing a shooting pain down my arms and legs and through my back.

    "The surgeon told me that this pain could not possibly have anything to do with my implants but I would be able to have them removed if I wanted.  I know this sounds dramatic and disgusting, but to try to explain the depth of this pain would say only that I felt like there was rotting inside my chest while I was still alive.

    "The pain was so severe I felt I needed to have these things taken out of me.  Nearly 20 years after I sat in the surgeon's office as a young, healthy woman, I was now desperately ill and in unimaginable pain.  On November 16, 1993, I had another surgery and this time the implants were removed and not replaced.

    "I had asked for the implants to be returned to me.  Eventually, when I was able to look in the container, I found only one implant.  The other one, the right implant, I was told was too ruptured and could not be returned to me.  At home, I began having one crisis after another.  I wasn't able to get out of bed myself or even sit up.

    "I started asking questions.  Why, after this surgery, had I been so ill?  I had had numerous surgeries before and recovered in due time.  Lying in bed, I wrote for the hospital records.  I questioned my surgeon.  One day, as I was lying there reading over the paper, something caught my eye.  My surgery had begun at 1420 hours and was completed at 1443 hours.  Those 20-year implants that I had been telling my surgeon had been giving me so much grief were removed, from start to finish, in a mere 23 minutes, less time than it takes for me to get a haircut.

    "How could that be?  More questions to the surgeon revealed that implants had ruptured and had been somewhat adhered to the chest wall.  None of this was in the original OR reports and came out only after I continued to ask questions.  Could some of that silicone have been left inside of me, I was so desperately ill?

    "I owned a thriving hair salon and, no matter how hard I tried, I could not get rid of the terrible pain throughout my body.  I eventually had to close my business, sell everything I had worked for my entire life.  Life, as I knew it, was over.  I was 43-years old.

    "In February of 2002, a different plastic surgeon operated on the right breast and found a very large mass containing silicone.  The pathology reports confirmed it was silicone within the scar tissue.  Curiously, I asked about the size of it.  Was it the size of a walnut?  He said, no.

    DR. WHALEN:  Ms. Curtis Smith, if you could conclude, please.

    MS. CURTIS SMITH:  Thank you.

    MS. MORITZ-CIANCUTTI:  Good morning.  My name is Audrey Moritz-Ciancutti.  I have come here from Pittsburgh on my own and I have no conflicts of interest.

    I had a bilateral mastectomy at Mayo Clinic due to fibrocystic disease with reconstruction with silicone-gel implants.  My first rupture was two years later and both implants were replaced.  Over the years, I started to become ill.  I had a continuous burning in my chest and developed a very high sensitivity to any kind of heat and sun.  Fourteen years after that rupture, and MRI revealed both implants were ruptured.

    The surgeon that removed the implants left some residual tissue behind.  I think he thought he was doing me a favor because I opted not to have an additional implant put in that I would have some sort of breasts.

    My rheumatologist at Cleveland Clinic told me that, unfortunately, the surgeon didn't do me any favors, that in that tissue that was left behind were globules of silicone and there is silicone in my lymph nodes.  She felt that this silicone has caused my condition.  The silicone in my body explains why, immediately following the surgery, I began to have severe pain in my right arm and continuous swelling.  I developed a cyst on my hand which had to be removed surgically and, after two biopsies, I was diagnosed with scleroderma.

    I continued to suffer with extreme fatigue and depression and my immunologist diagnosed me with atypical-tissue disorder, arthritis, cognitive dysfunction as well as asthma and allergic rhinitis.  I suffer from recurrent bacterial infections and I go through monthly treatments of I.V. gammaglobulin.

    My body can no longer tolerate heat or sun and, two-and-a-half years ago, I had to leave Florida and move back to Pittsburgh because I could only tolerate a colder climate.  Today, I am experiencing new scleroderma lesions on my chest, abdomen, my face and the top of my head and, once again, the chronic fatigue is reoccurring.

    The bottom line is that I have silicone throughout my body because these implants ruptured and the doctor is sure this has caused my condition and this silicone cannot be removed.  There have never been any studies of the health of women with leaking silicone implants except for the one study conducted by the FDA.  That one study found painful disorders such as fibromyalgia among women with leaking breast implants compared with women with implants that didn't leak.

    The results might have been even more dramatic if they had compared to women without implants but we don't know that because no such study has ever been done.  If Inamed really wants to prove their implants are safe for women in the real world, they need to study the health of women with broken gel implants.  Instead, they avoided that by studying women who only had implants for a very few years.

    Thank you very much.

    MS. TEAGUE:  Ladies and gentlemen, my name is Cynthia Teague and I am a registered nurse from Baton Rouge, Louisiana.  Inamed had sponsored my trip allowing me the opportunity to be here today.  However, I am here because I am an individual recipient of silicone implants.

    I would like to address the panel regarding the use of silicone implants and encourage you to allow women to make the choice between silicone and saline implants for themselves.  I would like to offer my personal testimony as to the safety of silicone implants and to their importance in improving my quality of life.

    I decided on breast-augmentation surgery due to the postpartal change in my body and after breast feeding my three children.  I was feeling self-conscious, dissatisfied and eager for a change.  My self confidence was suffering and my body image was low.  I sought the consultation of a board-certified plastic surgeon and spoke with him at length about my concerns and desired outcome.

    My physician was very forthcoming with the benefits and risks of this surgery.  At this time, women had the choice between silicone and saline implants.  Ladies and gentlemen, I freely chose silicone implants.  That was over thirteen years ago and, since that time, I have had absolutely no complications or regrets about that decision.

    My surgical results were excellent and I remain as healthy now as when I had my surgery.  I attribute the remarkable improvement in my self esteem to the augmentation surgery.  I attribute the remarkable surgical result largely, in part, to the use of silicone implants.  In my consultation, I was able to handle both types of implants before making my final decision and I was also shown postoperative pictures of patients with both types of implants.

    I chose silicone because of their more natural look and feel.  My excellent surgical results further validated my decision to use the silicone implants.  Having the ability to choose what type of implants were placed in my body, was very important to me.  I felt that I was in control and in charge of my own destiny.

    Not all women have that opportunity today.  It is my belief that this choice should be extended to all women.  Being able to make important decisions for oneself is crucial.  Women in American have struggled for decades for this right.  It is my request that the FDA reconsider its position on silicone implants and restore this choice to each individual.

    MS. DOWD:  Good morning, ladies and gentlemen of the panel.  My name is Pamela Dowd and I have traveled from Boise, Idaho yesterday to come to you at my own expense because my family felt it was vital that the panel hear from a 28-year survivor of breast cancer.  Today, I stand before you totally breastless and I am proud.

    At the age of 27, I became a breast cancer statistic.  I never had chemotherapy.  I never had radiation.  I was never sick before or after the mastectomy.  But, in November, 1980, almost 22 years ago--23 years--I began the road through reconstruction hell with a bilateral breast reconstruction that included a failed latissimus dorsi flap and three ruptured silicone breast implants.  The first replacement was within 90 days.

    In June, 1987, when I experienced the third rupture, it sent me to the ER with a pain so excruciating, it felt as if thousands of needles were pulling and pushing through my body and I was literally pulling at my hair and screaming.

    After getting breast implants, I developed a constant cough and, at times, I choked on my own saliva.  I have peripheral neuropathy and burning in the spine.  I have IBS and photosensitivity.  I have been diagnosed with Sjogren's and Raynaud's and considered lupus suspect.  I have MS-like symptoms that cause me to fall at the drop of  a hat.  The silicone in my chest and vascular system will never go away.   My chest constantly itches and burns from the residual silicone.  My bones still scream with pain.

    In 1995, when I underwent explantation, my chest had to be scraped and cauterized to clean out the residue of the previous ruptured implants.  The American taxpayer will, at some time, be responsible for the cost of my healthcare as they are now responsible for the healthcare of other victims of silicone-gel-filled breast implants.

    We are being asked one more time to trust the manufacturers.  Their story is based on 41 years of corporate lies and we have no reason to believe they are telling the truth now.  The manufacturer-funded New York study in the early 1990s didn't ask if anyone developed breast cancer autoimmune disease after breast implants.  It asked if participants had ever heard of anyone who did, proof of nothing more than do people listen to gossip.

    In a federal depository in Birmingham, Alabama, lie 80 million documents of implant manufacturers, the ASPRS, FDA and others, telling the truth of this massive corporate coverup of the dangers of silicone-gel breast implants and I am a freelance researcher of those documents.

    I have survived breast cancer for 28 years and do not believe I deserve to have a faulty toxic product foisted onto me by corporations without a conscience.  The implant industry has taken away my health but they will not take away my hopes and dreams.  This, too I will survive.

    I ask you to please keep the ban on silicone-gel breast implants in place, not for my sake but the sake of generations of women to come who can and will become ill and disabled due to the toxins in the silicone gel.

    Thank you for your time.

    DR. WHALEN:  If any of the speakers have handouts, could they bring them directly to Dr. Krause rather than to any other panel member.  Thank you.

    MS. BORDELON:  Good morning, ladies and gentlemen of the panel.  My name is Lisa Bordelon.  I am a registered nurse and I have practiced in the field of plastic surgery for fourteen years.  I have also been actively involved as a study coordinator with both McGhan, Inamed, and Mentor adjunct studies from the inception.

    I have had silicone implants for some 20-plus years also.  I am not here today because Inamed has sponsored my trip nor because of any business affiliation we may have but as an individual recipient of silicone implants.  I am here to share my experience with and opinions of silicone implants.

    My decision to have implants initially was not unlike many others.  I simply wanted to be more proportionate for my body and to appear more feminine.  After the birth of my first child, I began to explore the option of breast-augmentation surgery.

    At the time of my initial consult in 1982, I was given a choice between silicone and saline implants.  I chose silicone because of their more natural appearance and feel.  The resulting surgery had a tremendous impact on my self esteem.  I was more proportionate.  My clothing fit better and I felt more feminine.  Basically, I felt better about me.

    Many patients today do not have the choice of silicone implants for their breast surgery unless they meet certain qualifying criteria.  For those select few that do meet these criteria, they often choose saline because of the prohibitive cost of silicone and because of the negative publicity received in recent years.

    As a plastic-surgery nurse, I see many patients with unacceptable results that may have been avoided by the use of silicone implants.  Therefore, many patients are undergoing multiple procedures to achieve a result they may never reach with the use of saline implants.

    I cannot say that my experience with silicone has been totally uneventful.  I have experienced encapsulation that has required surgical intervention.  But this is a condition associated with saline implants as well.  This response cannot always be predicted beforehand and makes no difference as to what type of implant is used.

    Great advances have been made in the manufacturing of silicone implants in recent years.  I do not believe that the silicone implants are more dangerous than any other medical device but, like any other medical device, there are inherent risks involved.  It then becomes the responsibility of the physician to inform their patients of these risks.

    I believe the decision to choose silicone or saline implants should be left up to the individual patient based on physician recommendations as to which result in a better outcome.  For me, the correct choice was to have silicone implants.  I would make this same decision again today.  I believe silicone implants offer a good safe option to those considering augmentation surgery and I hope you will see fit to, once again, give all women this option.          Thank you.

    MS. FORMAN:  Good morning.  I am Jessica Forman.  I am a cancer survivor and I have no relation to any of the implant companies.  I was here about ten years ago when FDA was holding its first round of hearings on silicone breast implants.  I was then a breast-cancer patient scheduling surgery to replace the tissue expanders for permanent implants.  I participated in that lobbying effort to persuade members of Congress and the FDA panel that silicone implants should remain on the market.  I feel very differently today.

    I had my first mastectomy in 1990.  I opted for immediate reconstruction and was actually in the hospital for surgery to equalize the normal remaining breast.  It all came to a screeching halt because my oncologist re-read the latest mammogram and found another suspicious spot.  Two weeks later, I had the second mastectomy and still wanted immediate reconstruction.

    Together, those two surgeries were a horror story,  the first, for emotional storms, the second for physical problems.  I had so many bad side effects that my doctor said to me, are you sure you are not an M.D.?  This is only supposed to happen to M.D.s.  Well, I am not.  But all those setbacks explain why, two years later, I was still scheduling surgery.

    Ten years ago, I didn't care about the future.  I wanted to look and feel as if I had never had breast cancer.  I wanted to wear a bathing suit, wear sleeveless tops.  I wanted to shop at Loehmann's in a group dressing room and not have anyone stare at my scars.  And I wanted it right away.

    It didn't happen.  It could not happen.  Some days, I look in the mirror and I hate my scars.  Other days, they are all right.  I can't wear some clothing styles.  They are simply too revealing.  Sometimes, I can't lift my arms over my head.  And I still can't find a bra to fit both parts of me.

    I know that the company testifying today provided data showing women with silicone or saline breast implants have a higher rate of complication than augmentation patients and I am upset to hear about that.  I have an older sister who also had bilateral breast cancer.  She got silicone-gel implants.  She is suffering so badly from these connective-tissue immune diseases that she almost cannot work.  She sacrificed everything to be able to work five hours a day.

    We don't know.  Is this from her cancer or is this from the silicone implant.  There is no way to find out.  For myself, I know it takes longer to heal.  I know I hurt a lot more and the fatigue factor has gone up tremendously.  I can't get in to work like everyone else in my office.  If I commute downtown for two or three days, I am exhausted.  I am too tired to cook dinner, remember anything, can't solve problems, don't know what I am talking about.  It is a lot easier if I can do this at home and cut out a two-hour commute.

    Hindsight is always twenty-twenty.  If I had cancer today, I wouldn't opt for immediate reconstruction.  I am not sure that I would have reconstruction at all.  I would, however, take a long time to investigate my choices.  There may be a better way than implants.  There are tissue-flat reconstructions.  They are not always appropriate.  Given my weight and medical health, my doctor refused to do them.  More power to him.  I think it would have caused more problems.

    Recommendation; I think we need a big caution flag waved.  There is a lot of information we don't have about cancer, the immune system and the safety of breast implants.  I would like to see much more long-term research on silicone before your restrictions are lifted.  I would like to make sure that they are long-term safe, not two years, not five years, but ten, fifteen, twenty years.

    I am not actually sure that gel implants need to be available since saline is.  But, if they are available, I would ask you to restrict them and to insist on truly informed consent.

    Thank you.

    MS. FJELSTAD:  (Read by Kathy Sachs.)  Good morning.  I am Kathy Sachs and I reading the story of Diane Fjelstad who is too sick to be here today.

    "In 1978, I was encouraged by a team of doctors, including an obstetrician, a plastic surgeon and radiologist to have bilateral mastectomies to prevent breast cancer.  I believed these doctors when they told me that the implants were perfectly safe, would last as lifetime and I would go to the grave looking better than most women.

    "Although I had early warning signs, I didn't suspect the implants.  There were unexplained blood disorders, a strange rubbery substance oozed through the skin of my foot, and a rash of new allergies developed which did not respond to treatment.  I could not understand my continual fatigue in the late '80s and '90s.  I was unable to drive to the next town, only fifteen miles away, without having to stop for a nap.

    "This was very foreign to me as I had been a competitive athlete.  My skin began to hurt.  Worst of all, I feared I couldn't continue to work as a high-school teacher due to my memory lapses, fatigue and continual illnesses.  In '95, I noticed a dyslexia-like problem with words and numbers.  Finally, I noticed that the left implant had seriously shifted and was pressing against my lungs.  Breathing became difficult.

    "I attended a conference on silicone exposure and discovered that many of my symptoms were classic; chronic inflammation, myofascial-pain syndrome, swollen glands, numbness and tingling, and, later, severe pain, early signs of Sjogren's syndrome, chronic-fatigue syndrome, muscle atrophy, low-grade fever, severe headaches, chronic sinus infections, lung problems and gastrointestinal problems.

    "My condition deteriorated very quickly in the fall of '95.  I was explanted in late January, '96.  The explanting surgeon was furious that I had been allowed to get so sick and that the doctors had not picked up on my symptoms and treated them earlier.

    "The simple explanting surgery turned out to take over five hours with black substances and school-bus yellow oil running all over the operating table onto the floor.  What a stinking mess.  The implants were filled with fungus and no sign of silicone gel remained in the ruptured shells.

    "Since that time, I had a routine bunionectomy and asked the operating physician to do a biopsy testing for silicone.  He was totally shocked to discover that there were, indeed, silicate crystals in the bunion.  I also know that I have lesions on the brain from the silicone as revealed in an MRI.  Who knows where else the silicone has settled since the body has few ways to rid itself of it naturally.

    "My life has been disastrously impacted by silicone-gel implants.  I have no breasts.  I was no longer able to work as a high-school teacher.  I had to go on disability.  My husband of 40 years divorced me.  My financial income has been reduced to one-fourth of what it was.  My health has been compromised in many ways as I have mentioned.

    "You will hear from some women who insist on being given a choice.  Don't do us any favors by giving us the choice of an implant whose safety is unknown after just a few years.

    "Thank you."

    DR. VASAY:  (Read by Dr. Diana Zuckerman.)  Hello.  I am Dr. Diana Zuckerman.  I am going to be testifying on behalf of myself tomorrow.  Today, I am just reading the testimony of Dr. Frank Vasay who asked me to briefly describe his research.  Dr. Vasay is Director of the Division of Rheumatology at the University of South Florida College of Medicine.

    Dr. Vasay did provide some testimony ahead of time.  I hope you have it.  He has personally evaluated approximately 2,000 symptomatic women, most of whom have silicone-gel-filled breast implants.  He has been doing this work for over twenty years.

    He wants me to say for him that he has been satisfied that some women's immune system does not tolerate silicone breast implants.  The syndrome remains undefined but recent information suggests that 10 to 25 percent of women are so ill approximately thirteen years after getting implants and that recent epidemiologic studies show statistically increased symptoms in women with breast implants compared to control groups.

    He has done some research and he asked me to describe it for him.  This is published in various places.  I had hoped his coauthor could do this for him, but she works at the National Cancer Institute and I guess that is a conflict of interest.

    He studied approximately 100 women who had rheumatologic symptoms as diagnosed by rheumatologists and who had silicone breast implants.  Approximately half of them chose to have their implants taken out as was suggested to them and the other half, although it was suggested to them, and the other half, although it was suggested, decided to keep their implants.  So that was his study group, obviously not randomly controlled.

    He followed them up for an average of 18 months.  What he found was a remarkable number of women who had their implants taken out and not replaced showed slow steady improvement.  The symptoms that they had were similar to fibromyalgia; muscle pain, chronic fatigue with multiple trigger points.  He points out that, unlike classic fibromyalgia, exercise aggravated the muscle pain.  So that was different from what one would normally see in fibromyalgia.

    He also found that some women got better and some did not, not surprisingly, but that most of the women who had their implants taken out did get better and most of the women who did not have their implants out got worse.  By "most," that was over 90 percent.

    There was a way to at least predict who would get better and who would not.  Women who tended to have a bad prognosis and ruptured implants with silicone debris in their chest wall so that the silicone had not been entirely removed and could not be removed.  He also found that women who had delayed removal where their implant had ruptured some years before but they hadn't gotten it out for quite a while also had a poor prognosis.

    He also found that the women who didn't do so well after getting their implants taken out tended to have an onset of problems very soon after getting their breast implants, usually within two years.

    He has, as I said, published some of this work and it will be made available to the panel.

    Thank you.

    MS. GROSS:  Good morning.  My name is Marcy Gross.  I have six minutes having combined time with another potential participant.  I am a health-policy consultant and a member of the State of Maryland's Women's Health Promotion Council.  I retired in November of last year after 25 years at HHS most recently as the Senior Advisor for Women's Health at the Agency for Healthcare Research and Quality.

    During part of my tenure at HHS, I also participated in the Secretary's ad hoc working group on silicone breast implants.  I give you this brief resume just to establish my familiarity with the issues you are considering today but I am here as a private citizen and I base my remarks on my personal views and on information available to the general public.  I am not paid.

    One legacy of my six-year tenure at ARC is a good appreciation of the need for women and policy makers to have a strong evidence base for making decisions on healthcare issues.  My concern today is that an adequate evidence base for the premarket approval of silicone-gel-filled breast prostheses does not exist and that the short-term assurances drawn from the applicant's study will override continuing gaps in the research on long-term risks.

    I can see from the information posted on the panel's website for the hearing that the FDA has done exhaustive background work including literature reviews, assessments of toxicology and chemical testing and extensive consideration of the clinical data.  All this and more will come to you over the next two days.

    But some facts are simple and have not varied in the twelve years since silicone breast implants were pulled from the market.  The studies available on the health aspects of silicone-gel implants are short-term analyses often involving mere handfuls of mice studied over the course of a few weeks in the case of toxicology and chemical testing and over a two-to-three-year period in the case of Inamed's core study being cited in this proceeding in support of a case for reintroducing silicone breast implants for unrestricted use.

    Yet, even these short-term assessments indicate that the rate of ruptures and other complications which lead to a reoperation remains unacceptably high, 20 percent plus for patients using implants to augment their figure and 45 percent plus for reconstruction patients.

    Thanks to our longer life spans, breast implants will stay in a woman's body for the rest of her life which can be 50 years or more.  A two- or three-year study simply doesn't offer the kind of assurance of safety needed.  It is a setup for future medical problems for women who have this type of device implanted, especially when retrospective studies show that, by ten years, most women with silicone-gel implants will experience at least one broken implant.  At least these women know they have a problem and have further surgery.  Silent ruptures are also a documented and recurring problem.

    Sometime in the next few days, I feel certain you will hear someone say that none of the several important studies of the possible risks of implants have shown that they cause long-term health problems.  You may even hear it said that, well, we use silicone in other implanted devices such as heart valves, knee joints, hip replacements, so why should silicone from breast implants be different.

    My response is that having bubbles or globules of migrating gel floating through a human body into and around organ is, on its face, a health risk.  As for silicone and other implanted devices, one doesn't expect bits of a heart valve to break off and migrate to the brain, liver, other organs.

    Further, patients who get hip or knee joint replacements are routinely warned that a small number of patients will have an immune-system reaction to the silicone fragments shed by newly implanted joints.  How is it that orthopedic surgeons know this problem but the breast-implant community continues to doubt.

    There is no health imperative behind the push to reintroduce silicone breast implants.  On the contrary, they are used in elective cosmetic procedures that often cause serious health complications associated with ruptures and the surgery, itself.  Although there are other options available to breast-cancer patients that carry fewer risks, for some, silicone-gel implants is felt as important to their recovery.

    We know that this choice will make them more vulnerable to future illnesses and complications and will obscure future cancer screening procedures.  But, again, we lack the kind of long-term studies that would allow their choice to be fully informed.

    This FDA panel will be making a decision that affects the lives and pocketbooks of women quite substantially.  There are emotional issues involved in the decision and results.  Implants are an expensive procedure especially when the cost of care for complications, reoperations, infections and other medical side effects are added in.

    About 250,000 new procedures were done last year at a cost estimated at approximately 5,000 each on average for a total cost of $1.2 billion to the healthcare system.  While much of this is paid for by the patient, the cost for reconstructive procedures that many cancer patients elect to have is most often covered by insurance and, of course, follow-up care also would be covered most insurance.

    What is the policy recommendation here?  The FDA found the middle ground twelve years ago.  While I would still prefer to not have seen the fourfold increase in implants that has since occurred, at least the current policy sends a strong cautionary signal to women with choices.  This should not change until we have more confidence that these implants are safe for long-term use and that will take time and more research, the kind of research that should have been initiated ten years ago.  Let's not miss another opportunity.

    I thank you for your time and attention this morning.  I see that you have an agenda which runs well into this evening so I wish you luck and stamina.  Thank you very much.

    DR. MASSEY:  Good morning.  I am Dr. Marga Massey.  I am an assistant professor of surgery and the Director of Basic and Clinical Science Research in the Division of Plastic Surgery at the University of Utah Hospitals and Clinics in Salt Lake City, Utah.  I have no affiliations or conflicts of interest with any implant device manufacturer and have paid my own travel expenses to testify at the hearings today.

    I use breast implants in performing both cosmetic breast-augmentation and breast-reconstructive surgery.  I am on a fixed salary as a University of Utah paid employee and receive no financial gain whether I perform breast-augmentation or reconstruction procedures utilizing breast implants.

    As an academic plastic surgeon involved in basic science research which occupies greater than 50 percent of my current time, I have restricted the majority of my clinical-practice interest to breast patients, both cosmetic and reconstructive.  I have been impressed that cosmetic patients are very informed about their current surgical options to enhance the physical appearance of their breasts.  This level of knowledge likely reflects the current availability of information regarding cosmetic breast augmentation on the Internet and through the mass-media coverage of this topic.

    Breast-cancer patients additionally master a very complicated variety of breast reconstructive options to include but not limited to tissue expansion with delayed breast-implant placement, immediate breast-implant placement in the setting of skin-sparing mastectomy and the use of autologous muscle flaps which may be augmented by the placement of the incorporation of a breast implant in order to restore the appearance of a natural breast after a mastectomy.

    Many speakers today will provide testimony regarding the safety of silicone-gel-filled breast implants.  My personal review of the published information to date regarding the safety and efficacy of silicone-gel-filled breast implants supports their availability to cosmetic patients for breast enhancement.  This availability would mirror that which is currently acceptable for breast-reconstruction patients.

    As a plastic surgeon practicing in an academic setting, along with my colleagues here today, we eagerly await review of this most recent evidenced-based investigation.  We wish to continue collaborative scientific clinical investigations with the FDA and the device manufacturers to ensure patient satisfaction and safety.

    When the final review of this most recent evidence-based investigation becomes publicly available, I believe women will be empowered to make informed choices regarding the use of silicone-gel-filled breast implants.

    In conclusion, breast-implant device availability in clinical use should be based on sound scientific investigation.  Public education should be based on sound scientific investigation.  Implant-device availability and public education based on sound scientific investigation will ensure patient safety and will allow patients to make informed personal decisions regarding the use of silicone-gel-filled breast implants for cosmetic enhancement and for reconstructive restoration after mastectomy.

    I greatly appreciate the panel's time and consideration.  Thank you.

    DR. WHALEN:  Dr. Massey, would you entertain just one question?  I appreciate your full discloser at the beginning.

    DR. MASSEY:  Yes, sir.

    DR. WHALEN:  But is it your contention, in your academic environment, that there is absolutely no relationship between any volume of procedures you do and present and future income?

    DR. MASSEY:  I beg your pardon?

    DR. WHALEN:  I am in an academic setting, as you are.

    DR. MASSEY:  Yes, sir.

    DR. WHALEN:  And certainly the number of procedures that I do will impact, at a divisional and departmental level, a revenue structure that does impact upon the income of I and my fellow faculty members.  You said you are on a fixed income.

    DR. MASSEY:  I am on an absolute fixed income that has no reflection on the number of surgical procedures that I perform.

    DR. WHALEN:  So your department is able to remunerate you even if you do zero procedures or you do 200?

    DR. MASSEY:  That's correct, sir.

    DR. WHALEN:  Thank you.

    DR. MASSEY:  Thank you.

    MS. WOLF:  My name is Carolyn Wolf.  I live in Virginia.  I came here at my own expense.  I have no conflicts of interest.

    In 1971, I had a double mastectomy and was reconstructed with what were then considered new and improved silicone implants.  That was the time when breast implants were much thicker than they are today and were a rarity.  Few women have had implants as long as I did.  There are no published studies focused on women with implants for longer than 25 years because so few implantees have lived so long.

    I would like tell you what happened to me.  At first, I had no health problems and, even when they started, I had no idea they were related to the implants.  But, after nine or ten years, I developed dozens of hard, burning blister-like growths on my neck and boils on my forehead.  I have pain and numbness in my left shoulder, arm, hand and foot.

    By 1993, my family had noticed a distinct change of personality and I noticed cognitive changes.  I am diagnosed with rheumatoid arthritis, Raynaud's, irritable-bowel syndrome, silicone-induced MS-like syndrome with neuropathy of the extremities.  I have neurological damage to the left eye.  My silicone level is double normal.  This is two years after explantation.

    My brain MRI reveals more than 20 lesions.  In March, 2000, a batch of silicone moved from my left breast into my armpit leaving an elongated swelling in its path with excruciating pain.  On April 13, 2000, I lost vision in my left eye for 45 minutes.  I had constant pain in that eye for six weeks but, after a long, thin greasy glob came out of it, the pain lessened.

    I have had two similar strings come out of my left ear in the last year.  That is 30 years after implantation.  Although I did not smoke, I was coughing up hard gold-colored globs and a lung X-ray showed chronic obstructive-pulmonary disease.  Although the type of silicone implants that I had were thicker than those of today, MRI showed both implants ruptured.  I went to three different plastic surgeons but they only wanted to install replacements.

    When my implants were removed three years ago, both implants were extensively ruptured, both much smaller than when they were implanted.  The scar capsule surrounding the implants had cysts filled with chronic inflammation and foam cells containing silicone materials.

    Chest X-rays show that I still have silicone in the breast area.  I am still exuding silicone from the nipples and have deposits of silicone in both armpits.  Researchers at the National Cancer Institute have conducted the only studies of women who had implants for at least eight years.  They found that women with implants were more likely to die from certain cancers and suicide.

    The FDA conducted the only study of women with ruptured silicone implants and they found they were more likely to have fibromyalgia.  If implants are so safe, make sure that the implant makers prove it.  The studies you will hear about today do not do that.  Please remember that, whatever you do, if implants are approved by the FDA, you cannot control the advice given by plastic surgeons many of whom are still claiming that breast implants are perfectly safe and continue to insist that broken implants should be replaced.

    We beg you, please protect the younger generation.  Thank you.

    DR. WHALEN:  Thank you very much.  I think that is an appropriate time that we will break for about thirteen minutes until 10:30.  I need to remind the panel members, as difficult as it is, that any discussions upon the topic at hand need to be public, in front of the microphone, so refrain, outside of this panel room, from discussing anything at hand.

    [Break.]

    DR. KRAUSE:  Let's continue, please.  Thank you.

    DR. WHALEN:  To try to keep on time, we are going to resume.  Actually, the next public presenter is going to be via a conference call from the Hofnagel Group.  They will have five minutes.  Probably there will be people filtering back in because apparently the rest rooms were engineered by the same people who did the elevators.  So we will have to have some forbearance for that.

    So the microphone is already rigged towards the speakerphone and we will initiate with the Hofnagel Group's discussion.

    DR. HOFNAGEL:  Hello.  We are speaking to the committee.  We had difficulty hearing before.  My name is Dr. Vicki Hofnagel.  I have a group called the Hofnagel Institute.  We came before the FDA previously on multiple issues.  In 1994, I presented documents to the FDA showing that saline silicone breast implants still had migratory silicone into the chest wall of women.

    At that point of the purpose of that discussion and conference was to discuss the fact that surgeons who were removing implants were replacing implants and not taking tissue to study it from migratory silicone.

    At this time, we supported the decision by David Kessler because he was looking at life-long chronic complications not life-threatening complications.  The implants that are being presented have not changed in their design, the manner in which the protocol for placement or the protocol for follow up has occurred.

    In this hearing, the availability to give public testimony is wonderful as it is in all hearings.  However, that public testimony is usually not taken into consideration whatsoever as seen in the May, 2000 uterine-artery-embolization discussion before the FDA.

    We will be petitioning to the FDA to request that all FDA hearings will now be made public with public-television and also on the Internet.  It is extremely important that this meeting be made known to women across the nation and throughout the world.

    The things that prompted the Dow Corning case are still existing today.  I still see women every day with silicone breast complications.  Virginia Gallagher will be speaking to that, the crystallization of silicone causing glass to cut into the chest wall, the implantation of migratory silicone onto the nerves, and things that have not been made public such as the common condition of chest-wall deformity from all breast implants being used today and that this chest-wall deformity is the cause of many of the complaints of pain, itching and heat discomfort that women have.

    This has not been known to the public.  You can take chest X-rays and see the actual rib deformations in all of these women.  Yet it is not a baseline study.

    There is much to be done.  We need a national registry that will actually take in all of the complaints and look at them from the past if not looking on to the future.  C-reactive protein, ANA, LE prep, complement fix, all of the routine studies still are not part of a strong protocol.

    We need to move forward and we should have seen a new design.  We have technology to increase tensile strength.  We have technology to encapsulate even a silicone gel.  But the technology has not been shown in the new implants.  Instead, we are given an implant now with a two-year shelf life.  That two-year shelf life and the aspect of the life of an implant is still not given to patients.  Informed consent and complete disclosure is absolutely a sham still today.  We need a much better educational program for women.

    If we are going to move forward and reallow silicone to be used, then we need to change the design of the implant, make sure that it has radiopaque material to see when it leaks because so many women have no idea that they have leaks, by they have symptomatology and they are basically told, honey, go home.  It is a little ache and pain.  You are crazy in the head.  And then, when we operate on them, we find that their entire chest wall has been destroyed.

    I am going to move on to Virginia Gallagher who is going to speak.  We had two other women who wanted to speak.  Those women are young and beautiful and, when they went to their physicians complaining of itching and burning and other difficulties, they were patted on the head because their breasts looked great.  They looked great.  These women were attractive.  They were scared to death to have their implants removed because of chest-wall deformity.

    Our institute notified the FDA in 1994 and we have continued.  We now have developed a plasma-state surgery using argon beam and liquids to actually prevent chest-wall deformity and the public is unaware of this.

    In the panel and committee, you should also have psychotherapists because of the reasons that women have implants and the reasons they do not present afterwards such as the two young women within our group and we will be forwarding documents.

    I conclude because of the time limitations.  We will be sending a formal document because we cannot put all the data in such a brief discussion--and move on to Virginia Gallagher.  We will close with Denise Bennett who is the attorney and counsel for the Hofnagel Institute on illegal issues.

    Thank you.

    MS. GALLAGHER:  Hello.  My name is Virginia.  I can't tell you in this short time the multiple problems that I developed, but I suffered many health problems and, within two to three days of surgery of having the implants put in, my back and chest area was completely erupted with red sores that left multiple scars all over and remain to this day.

    My implants became hard and lumpy, not only painful but socially embarrassing.  Can you imagine what it is like to meet an old friend at your alumni and have them give you a hug, jerk back and look at you in shock at your chest because they have just hit a rock wall.  That happened to me enough times so that I began to withdraw.  It was embarrassing and humiliating.

    My lymph glands were very sore and felt like they burning.  Within one or two months of the time my implants were put in, it was almost impossible--well, was impossible--to maintain totally normal range of motion with my arms.  It was impossible, also, to find a comfortable

    DR. KRAUSE:  Excuse me.  Could you wrap up, please.  We need to go on.

    MS. GALLAGHER:  It was uncomfortable to find a position to sleep in.  I asked the surgeon to remove them. He said, no, I would be psychologically damaged and that it would be an irreversible depression.  The social situations were humiliating but the pain was terrible.  My left breast grew to protrude from my body several inches more than the right breast and was inflamed and red.

    I was told by another surgeon that the implants didn't need removal, although they could be replaced with new ones.  At the time of my removal, the burning lymph glands were free of pain when I came out from under anesthetic for the first time in 26 years.

    I am outraged that doctors have no concern for our health, that they deny the health problems that results, that insurance doesn't cover the removal of the implants and for teaching--(operator interruption)--is inorganic.  It is not natural unless it is already there normally.

    I was told that these implants--I was not told that they were not a lifetime procedure, that they would need to be replaced at any time in the future.  When I got them.

    MS. BENNETT:  This is Denise Bennett wrapping up.  For a long time, manufacturers and regulatory--

    DR. WHALEN:  I am afraid that we need to move on because you are so far beyond the allocated time and I apologize for cutting you off.

    Let me just say to the rest of the people in the room as well, we try very hard to balance between the number of people who wish to speak to us and to try to allocate the time appropriately.  So we are not trying to efface--ignoring what people are saying by cutting people off but, rather, trying to balance that with justice towards everybody who wishes to be heard.  Indeed, there are many people who do wish to be heard.

    On the contrary, I have to interject at this point to what I have heard now at least twice this morning.  Having chaired the panel where we looked at saline breast implants, I can totally assure you that I, and our panel members, do not ignore what the public is saying.  We very acutely listen to what the public is saying and we take that into account.

    The next speaker, please.

    DR. JEWEL:  Thank you.  My name is Dr. Mark Jewel.  I am a board-certified plastic surgeon with over 25 years of experience with breast-implant surgery.  I have no financial ties to industry or health-professional societies.  I have been a clinical investigator for Inamed's core gel study and an investigator for Inamed in Mentor's cohesive studies.

    I am Vice President of the American Society for Aesthetic Plastic Surgery which will reimburse my expenses for travel and hotel.  Today, I am speaking as an individual.  I thank the panel for this opportunity to address the topic of patient informed consent and the management of expectations.

    I have a particular interest in this subject having researched and written the Patient Consultation Resource Book which is used by more than 40 percent of all board-certified plastic surgeons.

    With the Internet patients who see more information today than at any time in the past regarding breast-implant surgery, many arrive at the physician's office with a great deal of information including pictures of results from the websites, yet have an incomplete understanding of what will actually be their personal result of after breast-implant surgery.

    I believe we need to move beyond traditional approaches of informed consent to empower our patients to be actively involved in all aspects of the clinical decisions which precede breast-implant surgery.  We must effectively educate patients regarding potential problems that may occur subsequently.  In this way, the patient can better understand surgical risk, expected outcome, potential dissatisfaction and financial responsibilities of breast-implant surgery.

    Because the patient takes an active role in the entire process, she and whoever else she chooses to involve in her decision, are invested with a degree of responsibility and control over the outcome.  Physicians have discovered that, even though patients may sign a consent form, that does not necessarily mean they will in the future remember being informed about potential complications or the possibility of dissatisfaction with results.

    Research into effective methods of achieving informed consent is ongoing and plastic surgeons have funded such research to help determine the extent of informed consent in breast-augmentation procedures.  Informed consent means that the patient must be educated as to surgical alternatives and the probability of any unwanted outcome.  Risk must be quantified in ways that patients understand and communicating risk effectively is a complex task.

    Patients must understand the limitations of surgery and the process involved with recovery.  Patients need to understand this involves the potential for complications of the surgical procedure, itself, inherent risk of implanted devices and additional advisory information pertinent to the use of breast implants.

    It is essential for patients to understand that breast implants may need to be replaced over time.  I have been involved in developing materials for breast-implant patients that I believe successfully meet all the criteria that I have discussed today.  The FDA's ongoing regulatory process will ensure that sound science will determine what choices may be available for women going forward.

    Plastic surgeons welcome the current hearings which will determine whether silicone-gel breast implants can be available for general use.

    Thank you.

    MS. RICHARDS:  Dr. Krause, and members of the panel.  My name is Mary Ann Richards.  My transportation costs and hotel accommodations have been paid for by Inamed.  I have not been offered, nor would I accept, compensation for the time I have taken from my employment to present with you today.

    I am a four-year cancer survivor who chose to have a silicone implant after a mastectomy.  Between the time it was determined I would need a mastectomy and actual surgery, itself, I did considerable research on the various types of breast construction available to me.  After extensive research, I felt an implant would be my best option.

    The initial expander was put into place following my surgery on January 25, 2000, by Dr. Caroline Glicksman, an excellent board-certified plastic surgeon.  It was a saline expander and, as it was filled with the saline solution, I found it extremely hard and uncomfortable, a constant reminder of my disease and loss.

    As part of a cancer support group, I knew several other women who had opted for the saline implants and they, too, found them hard, uncomfortable and disappointing.  When I mentioned this to Dr. Glicksman, she said that I might be a candidate for a silicone implant.  She gave me some literature and I did extensive research.  After I did my homework, I felt that the silicone implant was the way I wished to proceed.

    I discussed this at great length with Dr. Glicksman and she gave me additional literature with both the advantages and disadvantages of silicone implants.  I decided to proceed and, on May 26, 2000, I had a McGhan silicone breast implant inserted.

    Losing a breast because of cancer is not easy, but facing daily the reality that the cancer might reoccur was, for me, far more difficult.  With my silicone implant, I am not constantly reminded of that possibility.  My silicone implant is comfortable, soft, and feels very natural, unlike my original saline expander.

    I feel I am a responsible, informed consumer.  I see Dr. Glicksman yearly.  I am aware that silicone implant have a limited life expectancy, much as a pacemaker or artificial knee or hip and will need to be replaced in the future, much as they would.

    I have never, for one minute, regretted my decision with regard to my silicone implant and feel very strongly that other women who have to face the horror of breast cancer and the mastectomy should have the same options available to them that I have had.  It is for this reason that I am willing to present before your committee about this very personal matter.

    Thank you for the opportunity to speak before you.

    MS. BANCARZ:  Good morning.  I'm Lisa Bancarz, a 1982 graduate from Pacific Union College and resident of California who had silicone-gel-implant surgery in 1987.  Following two pregnancies and breast-feeding both of my children, I found my breasts were asymmetrical.  I was not happy with this change in my appearance.

    I decided to have breast-augmentation surgery and scheduled an appointment with a board-certified plastic surgeon.  My surgeon discussed at length the pros and cons of the surgery.  I spoke to several of my friends and acquaintances who already had this surgery.  Some mentioned they were slightly more firm because of capsular contracture but they were happy and did not want them removed.

    I decided to proceed with the surgery and have never regretted it.  I remember several articles and media programs regarding the issue of silicone and breast implants from the early 1990s.  I spoke to my surgeon and he talked to me at great length regarding the silicone issues.  He explained that, since I was not having problems with the implants, I should follow the recommendation of the American Society of Plastic and Reconstructive Surgeons and not have them removed.

    I obtained more information from articles given to me by my physician and what I personally read in the newspaper and magazines.  It became evident, through my readings, that silicone had been, and still is being, used successfully for other types of implant procedures.  I am offended that a woman's option to choose a silicone-gel implant was taken away.

    I feel comfortable with my decision to have silicone-gel implants and have never regretted it.  Because of the controversy surrounding the silicone implants, I have attempted to keep up the studies and their results.  Again, I feel I made the correct decision.

    I have several friends who have had the surgery.  After seeing their results with saline implants, I am thrilled to have my silicone-gel implants.  My breasts are soft and feel like natural breast tissue.  I am extremely satisfied with the surgery and would not hesitate to have the procedure again.

    I would strongly recommend silicone-gel implants to friends and, yes, even my daughter if she expressed an interest at an acceptable age.  I am very appreciative and glad that I was given the opportunity to choose silicone-gel implants.  It is my strong belief that every woman, after consultation with her physician, should be able to determine which type of breast implants are best for her.  Silicone-gel implants should be an option.

    Thank you.

    MS. WRIGHT:  Good morning.  My name is Eileen Wright and I want to thank the panel for allowing me to comment on my nearly 20-year experience with silicone breast implants.  I currently work as a nurse manager within the Johns Hopkins Health System.  I do not have any financial interest in the manufacturer or its competitors.

    I am a breast-cancer survivor.  After my diagnosis and subsequent mastectomy, I chose to have breast-implant surgery.  At that time, I was under the mistaken impression that my implants would last forever.  I lost touch with the surgeon who performed my implant surgery very shortly after the procedure as he left the area to practice in another state.  I truly felt any further follow up by a surgeon would be unnecessary.

    It was not until nearly 16 years later that I noticed, one, my implants had appeared to rupture; two, I discovered implants were not designed or meant to last forever.  It was only through a conversation I had with a colleague who also had silicone implants that I learned implants, like any other medical device, may need to be replaced periodically.

    Needless to say, when I visited a local plastic surgeon in 2000, he advised me that the implants I had for 16 years needed to come out.  He also told me about the various surgical options available to me after the implants were removed.  As I look back on this process, it is clear to me that the science, along with the patient-education process, has evolved considerably since my first implant surgery in 1984.

    My plastic surgeon took the time to explain the range of reconstruction options available to me.  He noted that I did not need to replace my implants with silicone-gel implants if I did not want to.  He showed me, and allowed me, to handle examples of both saline and silicone implants and he detailed an exhaustive list of potential complications associated with the devices.

    When I expressed an interest in having the old gel implants replaced with new ones, he explained that rupture could occur again.  He also confirmed that I understood that the implants might still need to be replaced at some point in the future.  Until the time of the implants' rupture, I had been very satisfied with the outcome of my initial surgery.  Thus, I felt very comfortable replacing the old implants with new ones.

    It has been three years since my most recent implant surgery.  I am very satisfied with the result and now consider myself a well-informed patient.  It does not make sense to me that silicone-gel implants are only available to women for breast reconstruction.

    I think it is important that all women have the option of silicone implants available to them.  I believe they provide a look and feel that is most natural.

    Thank you for your time.

    MS. LOWENSTEIN:  Good morning.  I am Lisa Lowenstein from Fremont, California.  Inamed paid for my travel and accommodation to attend today's meeting.

    After breast-feeding and raising four children, I was not happy with the way my breasts looked and the way my clothes fit.  I decided that I wanted to have breast augmentation to restore the look and the feel of my breasts.  In 1997, I researched all the implants that were available to me.  In August of that year, I met with my plastic surgeon and he informed me that my only choice was saline-filled implants.

    I was not happy with that choice due to a number of reported rupture incidents and an unnatural look that it had a history of.  My next step was to have a mammogram done before the procedure.  Within 30 minutes of having the mammogram done, I received a call from my doctor stating that he wanted me to retake the mammogram and that he wanted me to see him at his office.

    During that appointment, my doctor explained to me that what he and the X-ray technician found were decalcified starburst spots on both of my breasts.  Considering the fact that my mother died from breast cancer, this was alarming to both me and my doctor.

    After discussing my options and the procedures, we decided it would be best to do a bilateral subcutaneous mastectomy, something that is rarely performed these days.  The surgery took place in September of 1997.  I was so scared of the possibility of having cancer.  My doctor was quite pleased when the surgery was over and the tissue expanders were put in for healing time.  The biopsy report came back negative.  What a relief.

    My doctor knew that the silicone-gel implants would be out for testing and maybe in time for me to have them.  He explained to me that if I was his wife, that he would want her to have the silicone-gel implants in this situation because they were, in his opinion, much more natural, softer, tier-drop shaped like real breasts, and feel like real breasts.

    He believed that there was less chance of leaking or rupturing and I trusted his opinion.  In May of 1998, after qualifying to be a case study, I underwent my final surgery to insert the silicone-gel implants.  My doctor informed me that these would be so much nicer than the tissue expanders and that, in time, would soften and drop into position like real breasts.

    I was ecstatic when the surgery was over.  I hardly had any pain and my breasts looked beautiful.  They were perfectly shaped, soft to touch and looked great in clothes.  I never had any side effects or problems of any kinds with these implants and, as time went by, they softened even more and looked more natural than my girlfriends who had saline implants.

    Even though I had all my breast tissue removed, my implants looked much more natural with no wrinkles and no hardness.  I am a very athletic women and work out at a health club very strenuously.  I wanted to make sure that these implants could keep up with and not limit me in any way.

    Nothing limits me in my life by having these implants.  I forget that I have implants most of the time and no one knows that these are not my own breasts and I never give my secret away.  The best part for me is that I am healthy and these implants look great.  I love being able to find clothes now that I fill out the top perfectly and evenly.  It is important to me that I am proportional.

    The worry about breast cancer is erased from my mind.  I would make exactly the same decision today if I had to.  I wouldn't change one thing about my experience.

    In the dental field, which is my background, we let the patients choose what kind of filling to put in their mouth, whether it is a lesser material, veenamalgam*, one-color silver, unnatural, or higher-quality materials such as a tooth-colored composite that is more natural and unnoticeable.  Based upon my experiences, patients that care about their appearance will choose the higher-quality composite because it is more natural and aesthetically nicer.

    The key word here is choice.  Women should have a choice of what kind of implant they want in their body from a list of all products deemed safe and effective.

    DR. WHALEN:  Can you conclude, please, Ms. Lowenstein.

    MS. LOWENSTEIN:  At the end of the day, I don't consider these an implant but part of my body.  Thank you for your consideration.

    MS. NYE:  Good morning.  My name is Kathleen V.F. Nye.  I rode in from Pennsylvania with friends and I have conflict of interest.

    I know from experience that silicone-gel implants will adversely affect the lives of many people if they are approved based on just a few years of safety data.  Not only are the women who are implanted at risk but, also, there is a trickle-down effect affecting the whole family.

    Inamed says that their new and improved silicone breast implants are safe.  I would like to relate my story of new and improved silicone breast implants.  My first experience was in 1968.  I was 22-years old and had a bilateral mastectomy.  These new devices started to get hard in about six months.  I also started having fatigue and joint pain and, in '76, I found a doctor who would remove them.  The new ones also hardened and were removed in '81.

    At this time, the doctor told me there was a new and improved version and they would not get hard.  I had the new and improved inserted in '81.  This new and improved silicone implant started to harden again in about six months.  After three years of much pain, I went to a plastic surgeon and told him just to remove the implants.  I did not want another set.

    But, again, I was told about a new and improved silicone breast implant.   Again, the new and improved implant started to get hard in about six months.  I started to feel lumps around the edge of the implant.  There were three masses.  The cancer was sandwiched between two masses of foreign material with giant cells.

    This started me on the road of more implant disasters.  I had a total of 13 implants including devices made by McGhan, a company now called Inamed.  In the early '90s, the implant came through the skin and popped out on its own.  I have a photo that I included in my presentation.

    I am sure you understand my concern when I heard the manufacturers are now trying to promote a new and improved silicone breast implant.  Talk is cheap.  It is easy to call an implant new and improved, but you won't know if it is really better until it has been inside a woman's body for five, ten or fifteen years.

    I urge you not to be as naive as I was when I was told that they are better than the old ones.  Please do not put these new and improved implants, silicone-gel implants, back on the market unless they have been tested for a long enough time to really prove they are safe.

    Thank you.

    MS. BUIKEMA:  (Read by Kirstin Hoskison.)  Hi.  My name is Kirstin Hoskison and I am reading for Betty Buikema.      "Every day has been a silicone day in my life for the last ten years.  In 1993, I became a support-group leader with two other special women, Kay Dlugopolski and Peggy Pardo.  We had the same thing in common, silicone breast implants.  One was for reconstruction after cancer, one to keep from having cancer because of recurring cysts, and one for cosmetic reasons.

    "We each became ill, have problems with the implants, had to have them removed and be reconstructed with our own tissue.  Our medical records and history are similar to those we have heard over and over from so many women.  Because we believed in the cause of fighting what happened to us, we began, at our own expense, to inform and educate ourselves and as many women as possible.

    "We have had the opportunity to meet and talk to hundred, perhaps thousands, of women across America and the world.  What we all had in common were silicone breast implants and the illness caused by them.  That many women couldn't be a coincidence.

    "When I heard that there are now three studies showing that women with breast implants are three times as likely to commit suicide compared to other women, I wasn't surprised.  We knew women who have committed suicide, something I, myself, had considered when the pain was unbearable, when it doesn't seem like the pain will ever go away, and doesn't seem like you ever get better and, when you have mutilated breasts and you are broke, in addition to the pain, it can be hard to feel that life is worth living.

    "The cost of having implants inserted is nothing compared to the cost of having them removed, not just in dollars but in health.  This has cost me all of my savings for retirement.  At a time when I should be enjoying life, all I can do is pay for pain-killing medications to survive.      "My own story started when I was 40 and had a double mastectomy because of chronic cystic mastitis and reconstruction with silicone implants.  I immediately had a hematoma.  A year and a half later, I had a small tumor near my rib cage which was removed a few months later.  By 1990, my left breast was deformed, probably due to rupture.  My implants were removed in 1992, but I was diagnosed with Sjogren's syndrome and later with atypical connective-tissue disease.

    "Are Inamed's current silicone breast implants substantially different from implants I had.  Will they leak or rupture, cause contractures?  Will some women be allergic to silicone?  Can you guarantee they will be safe this time?  Are women going to be guinea pigs again?  You know that silicone implants leak as they age.  Why would anybody think a two- or three-year study is long enough when everyone knows that most women's health problems don't begin until seven to ten years after they get implants.

    "I am not here to tell you what to do.  I am here to beg you to base your decision on whether you would want your 17- or 18-year-old daughter to get these poorly tested implants.  Remember that if silicone-gel implants are approved, teenagers will be first to line up.

    "Thank you for listening to the women, but listen with an open mind and be sure they are safe before restrictions are lifted.  You owe this to the women who are depending on your judgment."

    DR. GLICKSMAN:  Distinguished panel members, I have no financial affiliation to any corporation.  I have come to testify before you today as both a plastic and reconstructive surgeon and as a woman, wife and mother.

    I began my experience with breast implants in the late 1980s where, at Memorial Sloan Kettering, I performed close to 350 breast reconstructions and augmentations using both saline and silicone implants.  In 1992, I began using only saline implants for augmentation and reconstruction and was an investigator in the McGhan saline study for five years.

    For seven years, I limited my patients to only saline implants while I, like my colleagues, followed the national and international studies on silicone and systemic illness.  When, in 1998, the European nations declared silicone implants safe, I became an investigator in the FDA adjunct silicone study with Inamed.

    To date, I have implanted 130 women with over 300 silicone implants.  I have followed these patients for close to five years with no reported systemic illness and a capsular-contracture rate of less than 1 percent.  You have before you the data, the science, but I would like to talk to you as a physician and a woman.

    I, like many of my patients, am a 40-something-year-old mother of four small children.  We have all heard the arguments of the National Organization of Women.  Women should feel good about themselves.  Women don't need to diet and exercise.  Women don't need to feel attractive to men.  Well, I'm sorry, but NOW does not represent me or the thousands of my patients whom I have treated over the last twelve years.

    We know the early detection of breast cancer and mastectomy saves women's lives.  If we are to encourage women to undergo such procedures, we must be able to provide them with an aesthetically natural, soft and comfortable breast reconstruction.

    The majority of my patients seeking breast augmentation are in a similar position to myself, in their 30s and late 40s, have had several children and desire the fullness they have lost to pregnancies and breast feeding.  They are not looking for the Baywatch look.  They are well informed, educated, mature, American women who are seeking to restore their self esteem and improve their self image with a soft, comfortable breast implant.

    If you, as a panel, carefully review the last ten years of rigorous epidemiologic peer-reviewed studies, you will see no proven connection between silicone and systemic illness.  Therefore, the final decision as to which implant to use should be made between the well-informed patient and her physician.

    No medical device can guarantee a lifetime of safety.  Capsules, often tender and uncomfortable, form around neurostimulators, pacemakers and heart valves, and total joints do not last a lifetime.  When I sit with my patients, we weigh the risks and benefits of any surgical procedure.  Total joints may increase mobility and relieve pain and heart valves may prolong life, but both procedures carry considerable morbidity and mortality rates.

    But what are the benefits of breast implants?  Who determines that the benefits of breast implants are not valid?  Is self esteem and improved quality of life only reserved for men on Viagra?  Are we protecting women in America or denying them the free choice that women in the rest of the world already have.

    I urge you to let the science of medicine speak, not emotions, hysteria, money or politics.

    Thank you.

    DR. WHALEN:  Excuse me, Doctor.  I don't believe you stated your name.  If you could, please?

    DR. GLICKSMAN:  Dr. Caroline Glicksman.

    DR. WHALEN:  Thank you.

    MS. GILBERT:  Dr. Glicksman, I have a question.  Can you tell me how you followed these patients?

    DR. GLICKSMAN:  I follow my patients at six-month intervals.  I bring all my patients in, whether the study guidelines are at six months or a year or the three years and five years.  I follow all my patients every six months.  I bring all my patients back on an annual basis regardless of the study guidelines.

    MS. GILBERT:  Is this done through MRI or is it physical examination?

    DR. GLICKSMAN:  Physical examinations, mammography, annual mammography for those patients who are appropriate, unless there are problems, then ultrasounds and MRIs.  But I have not had any problems that required those testings as of yet.

    PROF. DUBLER:  Dr. Whalen, since the panel is arranged so that we can't see who is talking, could you ask panel members to who ask questions to please state their names.

    DR. WHALEN:  And who were you?  (Laughter)

    DR. EDWARD MELMED:  I am Edward Melmed.  I have no financial payment made to me but my trip was supported by NOW.  I am a board-certified general surgeon and plastic surgeon.  I am board-certified in England, South Africa and the United States.  I came to the United States in 1973 as assistant professor of plastic surgery at the Southwestern Medical School in Dallas and I am currently in private practice.

    I did an enormous number of breast implants.  I actually started in plastic surgery doing implants before there were implants.  We used to use buttocks.  I have seen the evolution of implants and I wrote extensively about it.  In 1992, I changed and I started seeing women with problems.  And now, when I counsel women and I want to tell you I have now done over 600 explantations, and if you include the miserable Pep implants, probably about 650 because every one of those ruptured.

    When I meet with women I tell them there are three problems with implants.  The first is they rupture.  Now, when you see an implant that is three-years old and you take out an implant that is three-years old, you are going to see a perfectly good gel implant that is not sticky.  It does not cause any problems.  The likelihood of capsular formation is minimal.

    When you get to four-and-a-half years, and these are implants that I have explanted fairly recently--when you get to four-and-a-half years--I beg your pardon.  I don't do that quite as roughly when I explant.  (Laughter)  I will get to it eventually.  I apologize--the implant is now starting to get sticky and if I wasn't wearing gloves, I'll have a residue on my hands. Implants are porous.  They have silicone bleed from the Day 1.  But when they get to four-and-a-half y