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