U.S. FOOD AND DRUG ADMINISTRATION
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
MEDICAL DEVICES ADVISORY COMMITTEE
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GENERAL AND PLASTIC SURGERY DEVICES PANEL
EVENING SESSION - OPEN PUBLIC
COMMENT
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66TH MEETING
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MONDAY,
APRIL 11, 2005
The
Panel met at 6:35 p.m. in Salons A, B,
and C of the Hilton Washington, D.C.
North/Gaithersburg, 620 Perry Parkway,
Gaithersburg,
Maryland, MICHAEL A. CHOTI, M.D., Chairman,
presiding.
PRESENT:
MICHAEL A. CHOTI, M.D., Chairman
GRACE T. BARTOO, Ph.D., RAC, Industry
Representative
BRENT A. BLUMENSTEIN, Ph.D., Voting Member
LEIGH F. CALLAHAN, Ph.D., Temporary Voting Member
LEELEE DOYLE, Ph.D., Consumer Representative
CHERYL A. EWING, M.D., Voting Member
A. MARILYN LEITCH, M.D., Voting Member
STEPHEN LI, Ph.D., Temporary Voting Member
JOSEPH LoCICERO III, M.D., Voting Member
BARBARA R. MANNO, Ph.D., Temporary Voting Member
MICHAEL J. MILLER, M.D., Voting Member
AMY E. NEWBURGER, M.D., Voting Member
DAVID KRAUSE, Ph.D., Executive Secretary
P-R-O-C-E-E-D-I-N-G-S
(6:35
p.m.)
EXECUTIVE
SECRETARY KRAUSE: We're going to try to
get this session moving so that the sooner we get started, I guess, the sooner
we'll get done and we can all go home.
So if everybody could grab a seat and all the speakers for the evening
could make their way up front and introduce themselves to AnnMarie so that she
can line you up, we'll all be happy, and we'll get -- we'll get the ball
rolling.
We'd
like to remind all the speakers to please make your financial disclosure --
state your name at the beginning of your presentation and make your financial
disclosure. Also, we anticipate many
speakers and we want to keep on schedule, so those lights -- there's lights on
the second podium. When the yellow
light comes on, that means you have 30 seconds left. When the red light comes on, that means you're time is up,
whether it's three minutes or five minutes, depending on whether you're an
individual speaker or representing an organization. And then once Dr. Choti
asks you to please sum up, you have a few seconds before the microphone gets
cut off. We hate to do that to anybody,
but sometimes we wind up having to do that.
So, please, make your statement, be concise, and we can get going. Okay?
AnnMarie,
are you ready? Dr. Choti, please.
CHAIRMAN
CHOTI: Please, welcome first speaker.
MR.
HEYISON: Thank you. Good evening. I want to thank you for
allowing me to testify tonight. My name
is Marc Heyison, and I'm not being paid by any organization in exchange for my
testimony.
In
1999, I co-founded Men Against Breast Cancer, the first national nonprofit
designed to educate and empower men to be effective caregivers when breast
cancer strikes a female loved one. My
mom, who'll also be testifying this evening, is a 13-year breast cancer
survivor and her courage is the inspiration behind the creation of Men Against
Breast Cancer.
First,
there are three topics I wanted to cover tonight. One is choice; two is interference with mammograms; and the third
one is long-term safety. I wanted to
start with choice because in considering silicone breast implants, choice seems
to be the strongest argument for approval.
I am strongly for choice for everyone, but a safe and informed choice.
Over
the course of this meeting, I am sure you have heard and will hear from breast
cancer survivors, healthy women, and/or plastic surgeons about the importance
of choice in reconstruction between saline and silicone breast implants for
augmentation. My question is: are
aesthetics worth documented long-term health risks just to say you had a
choice?
We're
talking about the approval of a medical device requiring serious and risky
surgeries, and will remain implanted in a woman's body until they fail, and 95
-- and 93 percent of those will fail within ten years, according to a "New
York Times" article just this last week.
If
approved, breast cancer survivors who have been battling traumatizing and
damaging things, such as mastectomies, rounds of radiation and chemotherapy,
will face additional complications and risks because of these devices. In fact, data reviewed by this very
committee in 2003 show the reconstruction population experience far more
complications and repeat surgeries, and nearly half the women had at least one
additional surgery in the first few years.
If approved, healthy young women are at risk of a lifetime of repeat
surgeries, pain, and other complications.
The standard for approval of this medical device should not be based on
a level of perceived demand or allow a choice in breast implants. They should only be approved if they are
proven safe for all women, which is not the case.
The
second issue, to me, and quite compelling to the breast cancer community, is
silicone breast implants obscure mammograms.
Two recent studies, one in the "Journal of the American Medical
Association" in January of 2004 and another conducted by the FDA's Office
of Surveillance and Biometrics, also in 2004, clearly, clearly demonstrate
breast implants result in missed and delayed diagnosis of cancer. According to the FDA's study, because
silicone is radiodense, it has been shown to obscure between 22 to 83 percent
of breast tissue.
While
studies of this nature have not yet been able to definitely clarify difference
in mortality, the FDA's study outlines research showing that there is, and I
quote, "a difference in and possible limitation of treatment
options." Women with breast
implants more often had to undergo a total mastectomy instead of breast
preserving procedures because of delayed diagnosis of cancer. According to the FDA, even under ideal
conditions, alternative mammography techniques are limited and pose risks, and
it still may be difficult to find cancer because the scar tissue develops
around implants and can further obscure mammography.
The
additional images necessary during screening may subject women with breast
implants to at least double the radiation dose per mammogram than normal. The FDA's study also found that at least
some portion of the breast implant population would stop having mammograms
altogether because of severe pain and the fear of implant rupture during the
mammogram. My mom is here today because
of early detection, and it is widely medically accepted that the earlier breast
cancer is detected, the greater the likelihood of successful treatment. Complications from mammography are a real
risk and should be considered as heavily and seriously as other
complications. This fact alone strongly
argues against approval of these devices at this time.
There
is life after breast cancer and that should be of the highest quality because
the best care available was given and received. No one should have to look back and wonder if they made a choice
for choice sake that could cost them their health and vitality.
My
last area of concern, which was made clear from your 2003 panel meeting, are
the many unknowns and concerns about the long-term safety of silicone breast
implants, why the reconstruction population experiences significantly more
complications and re-operations than the augmentation population. What are the long-term effects and complications
of the real problems of silent or asymptomatic rupture, gel bleed, and silicone
migration? If silent rupture and gel
migration pose a risk, how is this risk addressed since the device does not
fail in a manner that alerts women, such as with saline breast implants?
The
only way women will have a true informed and safe choice is when we fully
understand these devices, their failure and long-term, if not lifetime,
risks. The goal should be approving a
safe device, not labeling an unsafe one for choice sake. I sincerely hope the panel will address
these concerns before a final vote against approval of these devices at this
time. Thank you again for your time
this evening. I appreciate it.
CHAIRMAN
CHOTI: Thank you. Next speaker, please.
MS.
HEYISON: Thank you. Good evening. I would like to thank you for
allowing me to testify. My name is
Gloria Heyison, and I'm a 13-year breast (sic) survivor.
In
1992, I was diagnosed with lobular carcinoma in situ. My world turned upside down.
Despite the devastating diagnosis, I was fortunate to have two caring
sons and a husband who held my hand every step of the way, from diagnosis to
survival. My son, Marc Heyison, is also
here to testify, founded Men Against Breast Cancer in 1999, to help men become
more supportive partners when breast cancer strikes a loved one.
My
story of survival starts at Johns Hopkins, where I had the best care
available. Because of the nature of my
breast cancer, I needed a radical mastectomy, and I was treated with Tamoxifen
afterwards. At the time of my
mastectomy, I was offered the option of breast implants. Based on the information provided, I
seriously considered them as a reconstruction option, but a twist of fate
prevented it. I had a terrible
infection from my initial biopsy that meant I would have needed separate
operations for the mastectomy and breast implants. I went home, discussed my options with my husband, and decided
against reconstruction based on the fact that I would have needed an additional
surgery.
At
the time, deciding against breast cancer implants was a small sacrifice to
avoid the added risk of one additional surgery. Little did I know that had I gone through with reconstruction
with silicone breast implants, I would have been risking a lifetime of repeat
surgeries and serious complications.
Data reviewed in 2003 showed that nearly 50 percent of reconstruction
patients required at least one additional surgery in the first three
years. I was astounded to read in
the "New York Times" on April 7, that
was my 48th anniversary, that the FDA estimates that 93 percent of women
undergoing reconstructive surgery will have implant failure within ten years,
and data reviewed in 2003 show that the reconstruction population also
experienced four more complications than the augmentation population. Let me make an important point: additional
surgery and serious complications are a high price to pay for breast cancer
survivors who have already undergone treatment just to survive.
Based
on the information I have learned, I stand before you this evening, relieved
that I did not take the silicone breast implants and subject myself to a
lifetime of pain, surgery, a risk of other complications, such as silent
rupture and gel migration. Breast
cancer survivors deserve a chance at a healthy life. Don't take that chance away by approving an unsafe device. Thank you for your time, and thank you
again.
CHAIRMAN
CHOTI: Thank you.
MS.
BASCH: Hi. I am Lauralee Basch from Toledo, Ohio, and Inamed paid my
expenses to come here. I want to thank
you for what you do to protect us from products that can potentially harm
us. Thank you for mandating that
companies perform extensive research to make sure their products are safe. Thank you for listening to a group of women
who seem to have health issues related to a product made to enhance their
lives. This product being silicone
implants. Thank you for doing your job
in protecting me as a consumer. You
have done a great job.
From
the research you have done, you have found no direct link from the use of
silicone implants to any disease process.
No scientific evidence of harm.
Countless women are subjected to a five-year study to help substantiate
your scientific findings that silicone implants are safe, and the research
continues, all with the same results: silicone implants cause no harm. Thank you for persistence in making sure I
am safe. Now it is time to let go. It is time to let me choose what I put in my
body. As not only a woman, but also a
registered nurse, I deserve the right to make an informed choice of silicone or
saline implants.
While
saline implants are fine implants, they do have a tendency to ripple and
wrinkle and are not as natural feeling and looking as silicone. Having had
experienced breast augmentation firsthand, first with saline implants and then
having had them replaced with silicone implants, I can attest to the fact that
silicone implants are the more natural feeling and looking implant. It was the best choice for me and I should
have been able to have had that choice initially.
Ironic
that in your years of research, you determined that cigarette smoking was not
only detrimental to my health but also to the health of those around me. You even warned me of this on the cigarette
packages, and let you allow me to make that choice to smoke. Your years of research on silicone implants
have not proven them harmful, nor have you been able to link them to any
disease process, and yet I'm not allowed to make that choice. It is time to let go. It is time to let me choose and I choose
silicone. Thank you.
CHAIRMAN
CHOTI: Thank you. Next speaker, please.
MS.
WALTON: My name is Bobbie Walton. I am reading testimony for Jean Winters, who
was too sick to be here today. She has
no conflicts of interest. I will read
her words.
I
have heard of the many stereotypes about women who get implants: stripper,
go-go dancer, emotionally unstable, etcetera.
Even if this stereotype were true, why should these women deserve less
protection against defective devices than women with more respectable
careers? What justifies a failure to
conduct a long-term study of an implanted device before using it on hundreds of
thousands of women?
My
name is Jean Winters. I am an engineer
and recently obtained a law degree.
When I was a teenager, a doctor told me my breasts were deformed. I had tubular breasts and was already
self-conscious about it. In my late
20s, I had surgery. The plastic surgeon
insisted that the implants would correct my deformity. He said nothing about the side effects. He said the implants would last a
lifetime. He assured me they would
cause no problems.
I
first became ill after I had a mammogram in 2000. At the time of my mammogram, my implants were 15 years old. The hospital was concerned that my implants
might obscure cancer. There was no
concern about rupturing the implants.
This is understandable since the medical community refuses to
acknowledge that ruptures create problems.
I believe that was probably when my implants ruptured. I developed many symptoms, including rashes
that never went away. One dermatologist
just told me to stop scratching.
Another suggested the problem may be systemic. I began to feel progressively worse. I had pain in my joints, numbness, extreme fatigue, and finally,
vertigo.
After
law school, I went to specialists, endocrinologists, rheumatologists, and
neurologists. I was diagnosed with autoimmune thyroid disease, Hashimoto's
thyroiditis, multiple sclerosis, and probable lupus. It never occurred to me that the problem might be my
implants. When I was doing legal
research for a retired physician, I told him about my health problems. He asked if I had breast implants. I considered the topic very private and was
embarrassed. He said that my symptoms
sounded like classic poisoning from silicone implants. At that moment, I could swear my heart
stopped. He suggested I tell my doctor
about my implants, which I hadn't because I believed the implants were of no
consequence to my health problems.
My
internist immediately ordered an MRI, which showed both implants were
ruptured. I had them explanted. I improved, but I continued to experience
pain and extreme fatigue. I worry about
what my future holds. I am 50, not yet
ready to retire or die. If I could turn
back the clock, I would never have had implants. I hope and pray that I can recover from this, but I have no
information on the long-term effects of silicone gel in the system. Doctors tell me they just don't know. This is outrageous, considering the length of
time silicone implants have been on the market.
CHAIRMAN
CHOTI: If you could please sum up. Thank you.
MS.
WALTON: Why haven't long-term studies
been done? Thank you.
CHAIRMAN
CHOTI: Thank you.
PARTICIPANT: Hi.
I'm reading on behalf of Dr. Laurie Young.
I
am Dr. Laurie Young, Executive Director of the Older Women's League: The Voice
of Midlife Women. I am a psychologist,
and prior to coming to OWL, I was Senior Vice President of the National Mental
Health Association. So today, I'd like
to use my expertise from both perspectives and talk about the mental health
benefits, or lack thereof, of breast implants for augmentation patients.
Over
the years, we've heard a lot from implant manufacturers and plastic surgeons
about the mental health benefits of breast augmentation. So an important question is: do breast
implants have mental health benefits for augmentation patients? Patients say they want implants to improve
their self-esteem and that it does improve their self-esteem, but no studies
prove that claim.
Studies
show that in the months following surgery, breast augmentation patients feel
better about their breasts, but not about themselves. When augmentation patients are compared to other women of the
same age, studies show that there are no differences in self-esteem, either
before or after augmentation. Is that
possible? Let's look at Inamed's own
data, as presented at the last FDA Panel Meeting in October 2003. That data showed a decrease on every measure
of quality of life, except feeling sexually attractive. Lower self-esteem, lower quality of
interpersonal relationships. Feeling
sexier or better about their breasts does not have the expected impact on
women's lives in general.
This
makes the studies about suicides and implants all the more important. Five studies have now shown that women with
breast implants have a 300 to 400 percent increase in suicides. Researchers speculated that women who
undergo augmentation may be more prone to suicide, but that is merely
speculation and is not backed up by any well-designed studies, and suicide
rates were four times as high when National Cancer Institute scientists
compared augmentation patients to other plastic surgery patients, including
women getting liposuction and tummy tucks.
It's
important to note that another Dow funded study, which purported to show that
breast implants were safe for women, in Denmark, actually found that women with
implants were at least five times as likely to take antidepressants compared to
women who do not undergo augmentation.
They also found that women with more augmentation surgeries were more
likely to take antidepressants, presumably because of the problems with the
extra surgeries.
So,
in summary, five studies show a 300 to 400 percent increase in suicides among
women with implants. Four of these
studies were of augmentation patients and one of reconstruction patients. Inamed's own data show a decrease in quality
of life and self-esteem two years after getting implants. No studies show an increase in self-esteem
two or more years after augmentation.
One Dow funded study of Danish women found much higher use of antidepressants
among augmentation patients, especially those with more than one augmentation
surgery. Thank you.
DR.
GLICKSMAN: Mr. Chairman and members of
the Panel, my name is Dr. Caroline Glicksman, and I'm reading the testimony
from my patient, Mary Elizabeth Dickerson, a 46-year-old mother of two, a
single mother of two, with stage III breast carcinoma.
Because
of my inability to attend, I'm requesting that my doctor read my
testimony. My name is Mary Elizabeth
Dickerson. I'm 46 years old. In
December of 1994, I was diagnosed with breast cancer and underwent a full
mastectomy with reconstruction. Through
a series of surgeries and thanks to a tissue expander, I was able to have my
breasts reconstructed with a saline implant.
I had that saline implant for seven years. My breasts certainly weren't identical and the saline implant
wasn't all that comfortable. It felt
like a tennis ball in my chest. It was
uncomfortable to sleep on my stomach, and because of the shape of it, it pulled
on my clothes, so the buttons of my blouses pulled to the right. Of course, these little things not being
bothered with when, in the grand scheme of things, I had my health.
In
2001, my doctor started to speak to me about switching to a silicone implant
and being part of a study of women with silicone implants. My doctor was participating in the study and
she gave me a lot of material to read and research before making my
decision. I had been with my doctor for
seven years at that point and trusted her completely. I made the decision to have the new implant put in and did so in
December of 2001. The silicone implant
is ultimately more comfortable, more symmetrical, and feels the same as my
natural breasts. I have had this
implant for over three years and have had no problems with it. In fact, in December of 2004, I was again in
the hospital for surgery for a recurrence of breast cancer. For the surgery, my doctor, working with a
thoracic surgeon, reopened the old incision, removed the implant, and after
removing as much of the tumor as possible, replaced the silicone implant in my
chest.
In
closing, I just wanted the committee to know the silicone implant is much more
comfortable than the saline implant. I
am very satisfied with it. Hopefully,
the work of my doctor and the other doctors are doing to get silicone approved
by the FDA will help other women to be more comfortable in their own
bodies. Thank you. Mary Elizabeth Dickerson.
MS.
VEVEZ: My name is Olga Vevez, and I'm
reading for Judy Kemecsei, who could not be here today. We have no conflict of interest.
My
name is Judy Kemecsei. I have no
conflicts of interest. When I got
silicone implants, I was never told about any of the risks. My doctor assured me they were safe. I went to a doctor a few years ago and told
her that I had no problems with my implants, but had read that they all
eventually leak. I asked,
"Wouldn't it be better to take them out now?" She said they looked great and were not
ruptured. I left them in. I had no health problems for 20 years, but
then started to feel pain in my chest and have difficulty breathing. I have
numbness and pain down my arms. I was
always very fatigued; just going to work was difficult. I called surgeons to get my implants taken
out. I thought the symptoms might be
related to my implants. I spent a lot
of money going from one plastic surgeon to another, and each told me that my
symptoms were unrelated to my implants.
I
had a number of mammograms. None of
them showing that my implants were ruptured.
I was told that an MRI would be better at detecting rupture, but I could
not afford the additional cost. I made the decision just to have the implants
removed and finally found a plastic surgeon who agreed to remove them without
replacing them. He said when he opened
me up, my implants were totally ruptured.
It was a mess. The silicone gel
went up to my clavicle and into my armpit areas. That was why I had the pain in my chest. It is very hard for me to believe that most
of the plastic surgeons don't know that the classic symptoms I had were caused
by implants. The doctor got out what he
could. Unfortunately, it can't be all
mopped up since it's like glue.
This
has changed my whole life. I had never
been sick, but now I'm in pain every day of my life. My breasts are very sore.
Who knows if they will ever feel the same again? I was cut open and scraped, not to mention
that the top of my breasts are indented now and my breasts will never look
normal again.
My
implants lasted a long time, but like most women in the FDA study of the
implant rupture, they eventually broke.
Even the implant maker's own data show that the implants break and women
don't realize it. If plastic surgeons
had told me that implants don't last, I would never have gotten implants. Plastic surgeons replace leaking and
ruptured implants every day, and put in new ones, like changing tires on a car.
I
was so happy when the FDA rejected Inamed's application at the end of 2003 and
demanded long-term safety data. If I
had been studied for only four years after getting implants, like the industry
suggests, they would have found nothing wrong with me. I was thrilled the FDA put the safety of
patients first. Why, we ask you? Why are we -- you back here today, barely a
year later, considering it again when there's still no long-term safety
data?
More
and more women are getting implants, especially young women, which makes your
responsibility even greater. Women
across the country are counting on you to protect us. Thank you very much.
CHAIRMAN
CHOTI: Thank you.
DR.
GLICKSMAN: Mr. Chairman and members of
the panel, I'm Dr. Glicksman, and I'm reading the testimony for my patient
Katherine, a 19-year-old college student.
At
the age of 16, I noticed one breast was not growing like the other; one being
completely flat, not even a AA bra size, while the other was growing normally,
already a full B. For an adolescent,
this defect came as highly uncomfortable, embarrassing, and even restricting on
a daily basis. For example,
embarrassment of changing in public areas, in gym class, for example, and
school, being unable to wear loose or open clothing, and the tortures of
putting on a simple bathing suit or going bra shopping. My new constant alert and sensitivity to
this bodily issue was very disheartening until I found hope a year and a half
later with my physician.
I
was told my case was pretty rare, definitely abnormal, and at my age, would not
resolve itself with much more growth in the future. Thus, I was recommended
plastic surgery and through a personal referral, found my doctor, my plastic
surgeon. Shocked, at first, that
plastic surgery was the way out, I started to learn for the first time about
breast implants and much differently from the way phony TV shows portrayed
them. My doctor covered everything with
me, excluding nothing: the initial history of implants around the world, cost
differences between silicone and saline implants, sizes, the importance of
finding a certified plastic surgeon, past and present concerns and debates over
these products, the risks involved then and now, and the choices and options I
had, along with their advantages, benefits, and disadvantages. Then, if I had any further questions or
doubts, these were addressed as well.
She recommended a foam implant sold in clothing stores to wear with
bathing suits to temporarily hide the physical difference and calm my constant
fear of being noticed, while I waited six months in case of any change in
development and turned 18.
On
my second visit in mid February, I returned, ready to make a decision about
surgery. I was given proper, clear
instructions on how to prepare for surgery, as well as reminded how the
recovery process would go. Three weeks
later, I underwent my first surgery ever, a unilateral breast augmentation
surgery, done by my doctor herself in a private hospital facility. I was prepared and the only fear I had was
of inexperience with surgery in general.
After my -- my doctor came in and asked me one last time if I still had
the desire to undergo surgery and filled out the remaining necessary paperwork
with the nurses and proceeded into the surgery room. The recovery was definitely not a quick fix deal, including much
physical discomfort to fulfill the needed healing while -- but with the help of
my doctor's orders on how better to recuperate, it was worth it. Nothing compared with the pain I felt for
years inside about myself, when I knew of no alternative, and before I had the
opportunity to make a choice that changed my life.
This
is what silicone implants have done for me.
While freedom is a word this country prides itself on daily, I was given
freedom to feel just like everybody else, through this surgery, this product,
and this deserved choice.
MS.
JACOBS: May I begin?
CHAIRMAN
CHOTI: Yes, please, go ahead.
MS.
JACOBS: I'm Marti Jacobs from
Arizona. I have no conflicts of
interest.
I
got silicone gel implants because of severe breast atrophy. I never wanted larger breasts and I never
would've gotten them had I known it would destroy my life, my career, and my
health, (slide one). I was healthy, yet
nine years later, I became very ill.
Tomorrow, industry will present only four years of data. Had I been in those studies, none of my
problems would've shown up. Surely, we
need long-term studies. After nine
years, numerous symptoms presented, such as, (slide two), significant hair
loss, as well as abnormal white blood cell count, fatigue, rashes,
etcetera. These symptoms coincided with
my right breast shifting lower than my left.
It did not occur to me that it was anything but a slight change in
breast tissue. Now I believe this is
when my right implant ruptured.
My
medical records document lupus, Sjogren's, fibromyalgia, and chronic fatigue,
all common conditions for many women with implants. I had to go on Social Security Disability. The Social Security Administration
determined my date of onset of my silicone-related illness was nine years post
implantation. Twenty years after
implantation, a mammogram report concluded there were no ruptures. Just months later, I had my implants
removed, only to find both were, in fact, ruptured. According to my operative report, "On the right side, there
was total disruption of the implant and no visible shell was seen. On the left side, there were also several
gross ruptures of the implant. It was
obvious that the implants had been ruptured on both sides for quite some
time."
Upon
removal, my neurological problems have somewhat improved, but I still suffer
with debilitating chronic fatigue and much more. Perhaps there is still silicone in my body. As you will hear from company data, most
women do not even realize when their implants break and mammograms are not
reliable to tell them. MRIs have been
proven to be more reliable, but how will women afford them? How would women get an MRI immediately upon
a rupture? How will women afford and
receive the urgent removal surgery they would need? That is why so many women have been exposed to leaking silicone.
What possible reason can these companies have for never providing you with
long-term safety data, especially when women like me have expressed our
concerns, over and over again?
I
question whether silicone gel implants can ever be proven safe, and ask you is
it against the -- if it's against the law to inject silicone gel into women's
breasts, what on earth makes it okay to put it in a breakable baggie? Since we know implants break down and
rupture, wouldn't it have to be proven safe for gel to be inserted directly in
breast tissue? That's what a rupture
is. If you approve these implants, you
will not be protecting women because they will believe they are safe, when,
clearly, this has not been proven.
Please just say no, and I have more pictures on a handout on a table
outside. Thank you very much.
MS.
WALKER: My name is Carol Walker and I
am reading the testimony of Jennifer Pythian, who didn't have enough money to
come to be here today. Neither of us
have any conflicts of interest.
My
name is Jennifer Pythian and I live in Denver, Colorado. I was 18 years old in 1986 when I received
my silicone breast implants. I didn't
start experiencing any health problems until approximately five years after
getting implants. I was increasingly
fatigued, experiencing burning sensations around my breasts, and suffering from
joint pain.
My plastic surgeon at the time was my
employer, and he told me that my problems were nothing to worry about. He said that if it was truly a concern for
me, he would replace them with saline implants. I could not afford the replacement at the time, and although this
was the same surgeon who had inserted my silicone implants for me at no cost,
he was not willing to replace them for free.
I believe that if my plastic surgeon had any sense of ethical
responsibility, he would've taken the silicone gel implants out for free since
he had put them in, but, unfortunately, that did not happen.
Because
of lack of money, I was forced to leave the silicone implants in. I had three children while my implants were
inserted and was unable to breastfeed any of them because the implants
prevented my body from producing enough milk to keep them healthy. Prior to implants, I was a very healthy
woman. I had never had any serious
health problems. However, afterwards, I
suffered from an array of illnesses that have caused me chronic pain, chronic
fatigue, and a daily feeling of unexplainable, overall ill health.
I
had my implants removed last December and I began to feel better
immediately. My health improved
dramatically, almost instantly. I no
longer feel fatigued, no more burning sensations, and no more achy joints. Every one I know has commented on how great
I look. Some have even said they have
not seen me look so healthy in a very long time. I can even tell a difference when I look in the mirror every day,
and I am so thrilled about how much younger I look and feel.
At
the time I was given my silicone implants, I was not aware of any risks and I
was not warned of any either. Maybe if
they did warn me of any risks associated with silicone implants, I wouldn't
have had them put in. Taking out my
implants is the best thing I could have done and wish that I could have had it
done sooner. I can only hope that my
experience and testimony will help other women. I wish I would have known then what I know now. I don't think you can force plastic surgeons
to give informed consent. My plastic
surgeon was my employer, but he did not tell me what I needed to know. I don't think he would've performed free
surgery on me if he thought it would harm me.
That's why I question whether there is any way women can truly learn
about the risks before getting implants.
CHAIRMAN
CHOTI: I'm sorry; if you could sum up,
please, for us, we'd appreciate it.
MS.
WALKER: All right. Instead of learning the hard way, as I did.
CHAIRMAN
CHOTI: Thank you.
MS.
GREEN: Good afternoon. My name is Minnedore Green and I'm reading
the testimony for Karen Curry. She nor
I have conflicts of interest.
In
1983, I went -- underwent a preventative bilateral mastectomy. I didn't consider reconstruction right
away. I had a difficult time dealing
with the loss of my breasts, which, to me, encompass my femininity and my
beauty, but enduring another surgery was far from the top of my list. Two years later, I consulted with a plastic
surgeon and was assured that reconstruction with breast implants was safe. The surgeon showed me photos of patients and
said that there were no complications to worry about. Reassured by his confidence in the procedure as a product, I was
reconstructed with silicone gel breast implants when I was 36 years old.
Just
one year later, I learned that there were, in fact, complications to worry
about. My implants began to harden and
began -- became extremely painful. I
began to experience serious health problems.
In 1990 -- in 1988, I was diagnosed with benign multiple sclerosis and a
number of other conditions. I have
always been an extremely active and healthy person. I have always had the energy to be active with my three children
and work full-time, but slowly, my health deteriorated. My husband took care of me when I could not
take care of myself. I was unable to do
the things that I love to do.
In 1997, a mammogram indicate