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 indicated that I had a small bulge in my right breast.  Concerned that the bulge might mean that my implant had ruptured, I went to a plastic surgeon to have them removed.  After 12 and a half years in my body, the plastic surgeon found that both of my implants had, in fact, ruptured.  Even more worrisome, the right shell was actually dissolving.  I was told by my plastic surgeon that because of this, she was unable to remove all of the silicone from my chest cavity. Perhaps because of the silicone left in my body, my health has not improved.

            I have since been diagnosed with fibromyalgia, atypical connective tissue disease, and chronic fatigue.  I have not been able to work since 1998, and I live on Social Security Disability.  I am a 57-year-old woman who was healthy all of my life until I was reconstructed with silicone breast implants.  I have lost my health and I have had to change my life dramatically.  The risk of rupture means the silicone breast implants are not safe.  It is essential that women have all of the information they need to make an informative decision, but, unfortunately, all the information is not available to them.  Why is that?  The FDA made it clear in last year that it was concerned about rupture and silicone leakage and that the companies must show that these devices are safe for its lifetime.

            CHAIRMAN CHOTI:  If you could wrap it up, please.  Thank you.

            MS. GREEN:  So where are the industry's long-term studies?  What are the health risks of implant ruptures and leakage?  And why haven't the implant makers studied that?  Thank you.

            MS. CONNOR:  My name is Holly Connor.  I am reading testimony for Brandy Markakis, who could not be here today.  She nor I has any conflicts of interest.

            My name is Brandy Markakis and I live in Menifee, California.  I was 24 years old in July 2000 when I first decided to get gel breast implants.  About two weeks after I had been augmented with saline breast implants, scar tissue buildup had already begun.  After ten months, I was experiencing severe capsular contracture, and I considered having my implants removed.  I was told by my new plastic surgeon that according to studies, I would be left deformed and depressed if I simply removed my implants.  She told me that I would be a great candidate for the new and improved silicone gel breast implants.

            In May of 2001, I had my saline implants replaced with silicone gel breast implants.  I remember signing papers in the waiting room of my doctor's office prior to surgery.  My surgeon mentioned briefly that the papers had to be completed for legal purposes, but I was assured that complications were extremely rare and usually only occur because of inexperienced doctors.

            About a year and a half after getting my silicone gel breast implants, I started noticing symptoms that I had not before.  I began to get severe headaches almost daily.  I was chronically fatigued.  I experienced joint stiffness and pain, short-term memory loss, and difficulty concentrating.  I also had hair loss, night sweats, and allergies.  I didn't suspect my implants as the cause of these symptoms and I went to my primary care doctor to figure out what the problem might be. He performed numerous blood tests.  He told me that I was probably suffering from fibromyalgia and chronic fatigue syndrome.  After experiencing so many symptoms that seemed unrelated to my implants, I started to feel extreme breast pain, especially in my right breast.

            At about the same time, I had an MRI and did not show a rupture, but it did show enlarged lymph nodes on my right side.  When I visited friends in Canada, I was able to get an ultrasound.

The doctor who performed the ultrasound recommended I have the implants removed as soon as possible and have another mammogram performed because of suspicious breast tissue on my right side that was being obscured by the implant.

            I had my silicone gel breast implants removed on February 25, 2005.  No rupture was found; however, I did have a large amount of scar tissue that was stuck onto my ribcage.  I am very pleased with my decision to have my silicone implants removed.  The surgery did not leave me deformed or feeling depressed.  In fact, the opposite is true.  It's been a little over a month since I've had my implants removed, and I'm feeling better with each day that passes.  Slowly, I am actually becoming the active and energetic person that I used to be.  I've gotten back to the gym, I am sleeping better, and the most important thing is that I feel good and I actually have the energy to keep up with my two children.

            Had I known the health risks associated with silicone breast implants prior to my surgery, I would have never sacrificed my health or the time I have lost with my family.  Thank you.

            MS. HANKS:  My name is Stephanie Hanks and I am reading testimony for Virginia Saxe, who is too ill to be here today.

            My name is Virginia Saxe.  I have no conflicts.  I am 62 years old.  I live in Wisconsin. When I found out I had breast cancer, I had a modified radical mastectomy.  A year later, I got breast implants.  I was told by my doctor at the time, Dr. Harold J. Hoops, that the implants were saline.  About nine years later, I started to experience extreme fatigue and joint pain.  I called Dr. Hoops to find out if the implants could be making me sick.  His nurse said she would check.  She called me back and said my implants were silicone, not saline.  I was shocked.  I had the implants removed.  They were ruptured and leaking.  It was devastating to face more surgery and recovery.

            At the time of this surgery, I had lumps on my legs, near the ankles.  The doctor biopsied the lumps at the time of explantation and told me it was silicone in the lumps.  I prayed that I would feel better after the explantation, but since there was silicone still in many parts of my body, I didn't.  I continued to be extremely tired, unable to do the simplest things.  I needed the help of family and friends.  Eventually, I had to stop working.  My husband didn't make a lot of money and we had two children to support.  I have been diagnosed with scleroderma and Raynaud's Disease.  My hands turn blue whenever I am cold, even from air conditioning.  My hands cramp badly.

            In 2002, I had triple heart bypass surgery.  My doctor told me they had to scrap the silicone away from my heart before they could do the surgery.  There were lymph nodes all around my heart.

            I was fine for nine years.  If I had been in a study for four or five or seven years, implants would have seemed safe.  Instead, they have made my life a shadow of what it could have been.  I have very little energy.  People my age are out having fun and able to do things I can't.  My husband passed away and my son has to drive me to frequent medical appointments, as well as grocery shopping and errands.  I live from day to day on Social Security.  This is no way to live.

            I had no idea when I was diagnosed with breast cancer that my real nightmare would be the implants, not the cancer.  Should breast cancer patients have choices?  Our choices should only be for safe products.  We deserve that much.  Thank you.

            MS. BENNETT:  My name is Lisa Bennett and I'm reading for Teresa Hamilton, who lives in California and is too ill to be here.  Neither she nor I have any conflicts of interest.

            My name is Teresa Hamilton.  In 1986, I was diagnosed with breast cancer at the age of 29.  My left breast was removed because of cancer, and a month later, my right breast was removed.  After getting McGhan implants, I looked and felt great for maybe two years.  After that, I started to get allergies to nickel and jewelry and allergies to pollen and penicillin.  I had repeated yeast infections and seemed to get more and more colds.  As a single parent, it became difficult to take care of my elementary school-aged daughter.  She would have to stay at my parents' house while I would try to recuperate.

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

            In 1999, I had my implants removed.  The left implant was weak, but still intact.  The right implant had dissolved completely, shell and all, into a gooey mess.  I'm still dealing with infections and a weak immune system due to my right implant dissolving into my body.  My doctors are still trying to clean up the mess.  I have since had a hysterectomy due to numerous fibroid tumors.  I now have a weak immune system, fibromyalgia, and a low thyroid.  I am constantly tired, despite medication to help my fatigue, asthma, and foggy thinking.  I can only work a few hours a week.  My parents, who are in their 70s, have to take care of me and pay for most of my medication bills and all of my living expenses.  My chest is scarred and disfigured as a result of all the surgeries I had to have to put in the implants in the first place.

            I see that the industry is presenting data showing implants are safe over a four-year period.  As I hope is clear from what I've just said, the problems caused by implants occur in the long-term.  These four-year studies are useless.

            I have been cancer free for over 14 years now, but I am still chronically ill.  I never had any of these health problems before having breast implants.  As you listen to the data being presented tomorrow, think of what it means to have ruptured implants.  Think of how it affects women's health and women's lives.  As you listen to the plastic surgeons testify about the safety of silicone implants, realize that women will never be able to get informed consent because plastic surgeons continue to tell patients about their satisfied customers.  They never tell them about women like me.  Thank you.

            DR. GINGRASS:  My name is Dr. Mary Gingrass.  I'm 42 years old.  I've been practicing plastic surgery for ten years.  I have silicone breast implants.  Thank you for taking my experience into consideration.  I'm receiving no compensation for my testimony.  I have no financial interest in Inamed or Mentor.  My practice consists of both cosmetic and reconstructive plastic surgery.

            I consider myself a pro-choice plastic surgeon.  I believe that women deserve to be educated and to have a choice regarding what kind of breast implant goes into their body.  Because of my surgical experience, I knew that silicone implants were the right choice for me.  When I decided to have augmentation mastopexy two years ago, I knew that I did not want saline implants.  In a thin woman like myself, saline implants feel like a bag of water because that's what they are.  Normal breast tissue does not feel like water.  I have a thin, boney chest, and I did not have very much breast tissue after nursing.  With saline implants, I would have had problems with wrinkling, which is especially prevalent in thin women with minimal or no breast tissue.  My silicone implants are submuscular.  They feel natural, like my own breast tissue.  I was willing to accept a small increased risk of capsular contracture to have the look and feel that I wanted.

            When I have a patient who qualifies for the clinical trials, and who I believe would benefit from a silicone implant, I fully inform her about the risks and benefits of both types of implants.  Neither implant is perfect for every patient and both implants have risks and possible complications. I make sure that she understands that there is a slightly increased risk of capsular contracture with silicone, actually in the older studies, and a higher risk of wrinkling with saline.  Then, in a few patients who have a choice, we come to a decision together based on her anatomy and an educated, informed consent.

            Unfortunately, many patients have a fear of silicone that is deep-seated and often based on inaccurate information and media hype.  I believe that you, the FDA panel, can help dispel some of this fear.  Let it be known that I'm not saying that we should put silicone in everyone.  There are truly women in whom it will not make much difference in their result because they have plenty of breast tissue or body fat to cover an implant.  I will not recommend increased risk of capsular contracture or added cost if it's not going to do them any good.  No one here is saying that we should do away with or eliminate saline implants.  We just want to have a choice for our patients who will truly benefit from a safe alternative product that is better for them.

            I appreciate your time.  Over the next several days, I ask you to remember that not everyone who needs or wants implants is necessarily 19 years old, has a high, tight breast and is trying to be the next scantily clad survivor.  Some of us have fed our children, or, unfortunately, have had our breast cut off due to cancer.  Some of us have little or, unfortunately, no breast tissue left.  We deserve a choice and it is time to dispel the fear that surrounds the safe product.  Thank you.

            CHAIRMAN CHOTI:  Thank you.

            MR. PERANG:  Good evening.  My name is Juben Perang (phonetic), and I'm here to read the testimony of Rodney Hayton from Texas.  He is unable to be here today.  Neither of us have conflicts of interest.

            My name is Rodney Hayton.  My wife became sick from her breast implants and I observed the progression of her illness taking a heavy toll in numerous areas of her life.  Approximately 18 months ago, these same two manufacturers submitted inadequate safety data.  Inamed received a not approvable letter; Mentor withdrew its application. What is significantly different in this short length of time?  In looking at the research provided, I'd have to say not much.

            For almost 15 years, these implant makers have tried and failed to get their silicone breast implants approved by the FDA.  Instead of conducting good quality research, which would have followed women for 12 to 15 years by now, the manufacturers stopped their studies, accused women with breast implants of making up symptoms for financial gain, and offered relatively small amounts as compensation to women with extremely expensive medical problems.  Many of the women could not even afford to get their ruptured silicone breast implants removed.  Their efforts to get accurate information about risks and to get affordable medical care has been sabotaged at every turn.  I have lived with these medical nightmares.

            In the past, the plastic surgeons on this panel have expressed concern about women who have been harmed by leaking implants and then snickered while they testified and ignored what they said.  I challenge you to actually listen to the patients, instead of assuming that they are wrong and you know better.  I ask you for once to think of the women whose lives you have destroyed.  I don't know if you are greedy or merely unaware of how many women have been harmed by leaking silicone, but I will tell you that you would feel differently and vote differently if these women were your loved ones.

            I was shocked to read the company executives telling "The Wall Street Journal" that their products have a very low rupture rate. Inamed's own data show that more than 20 percent of their reconstruction patients had a ruptured implant within the first three years, most of them diagnosed in the third-year MRIs.  Who could possibly consider 20 percent rupture during the first three years to be a low rupture rate?

            I have a question for Mentor executives, too.  Mentor's rupture rate was lower, but Mentor had a different problem.  Their study was so short-term that many of the women had only completed their first year MRIs, and Mentor excluded from their analysis all the women who had their implants removed and not replaced.  Now it is just common sense that women who just got breast implants would remove and not replace them, only if they had a rupture or other serious problems.  How can Mentor scientists justify excluding these women from their study, a study that is supposed to focus on women who have rupture or problems with their implants?

            Many women wish the manufacturers would develop safer implants and test them for long-term safety.  Why do they keep coming back with two-year studies that can't prove safety?  Thank you.

            MS. SMITH:  Hi.  My name is Sara Smith and I am reading for Roseanne Averill, who is too sick to be here today.  We have no conflicts of interest.

            My name is Roseanne Averill.  I got silicone gel implants when I was 32 years old.  My plastic surgeon never warned me about any possible risks.  The only warning I received was that if I didn't massage my breasts regularly, they could harden.  I followed this advice and was very happy with the cosmetic results.  In the late '80s, when I first developed Graves Disease, I never once thought it could be because of my implants.  My entire family thought it was very odd that I was so ill because there was no family history of any autoimmune disorders.  I still did not suspect my implants. 

            In the early '90s, I stared to develop a number of very odd flu-like symptoms.  My body would ache.  I would get low grade fevers.  My feet became extremely stiff.  My thought process became very slow, and I was extremely exhausted all of the time. Finally, after a number of months suffering from these debilitating symptoms, I was diagnosed with chronic fatigue syndrome.  Several doctors told me that my implants were not the cause of my illnesses. I was very reassured and convinced by their expert opinions.  There had been some suspicion of a rupture because of a diagnosed bulge found during a routine mammogram, but I was told that it probably wasn't a rupture.  Some time later, I found a radiologist who specialized in diagnosing ruptures through ultrasound, who confirmed that my implants were, in fact, ruptured.

            I was scared of what I would look like without breasts.  I was told that when plastic surgeons remove ruptured implants, they scrap the leaking silicone from your chest cavity and remove some of your own tissue.  I was so scared that I opted to simply replace my ruptured implants.  I was never told that because of my now diagnosed autoimmune disease, I should not get breast implants.

            My health progressively worsened.  I have difficulty with walking because my muscles are weak.  I have essentially become totally disabled.  About three years ago, I finally had the implants removed.  I don't understand why we are even here today.  The industry has decades to conduct long-term studies and they have not.  Why?  Don't women like me deserve answers?  Don't the hundreds of thousands of women thinking about getting breast implants deserve to know the truth?  It is not too late to examine women who have had implants since 1990, but judging from Inamed's four-year studies, it looks like if the companies study implants for more than two or three years, the rupture rates start to get much too high.

            If implant makers can't prove that their implants are safe for long-term use, then the FDA should stand by last year's decision to restrict them, and it's time for the implant makers to develop safer implants that they are willing to study for a longer period of time.  Thank you.

            MS. WILHITE:  My name is Kelli Wilhite and I'm reading for Caroline Bromm, who is too sick to be here today.  We don't have any conflict of interest.

            My name is Caroline Bromm.  I have no conflict of interest and no financial ties to anyone.  My declining health does not permit me to be here today, but I'm convinced the platinum and other chemicals from my breast implants started my health problems, and have asked that my testimony be read to you.

            My platinum urine levels when tested seven years after explantation were 178 parts per billion per liter of urine.  I have no known significant exposure to platinum other than my ruptured breast implants in my body for 21 years.  I can't help but wonder how my platinum urine levels remain high.

            Here are some of my many health problems and symptoms, which all started after receiving my implants.  I have a positive myelin autoantibody, IgG nerve damage, which causes pain in my fingers and toes and jerky twitching of muscles. I have Raynaud's and Sicca and I have had to have my tear ducts cleaned out as they get blocked and I cry tears even when I am not sad.  The constant tears make things very difficult.  I have ringing in my ears, dermatitis, asthma, swollen lymph nodes, and total hair loss on my upper body and major thinning on my head.  I have memory lapses that can be frustrating and very frightening.  Small, common words escape my vocabulary, and sometimes I do not know where I am or why I went there.  I have rashes and shortness of breath, and my allergies are on the increase.  I am very, very tired, full of pain, can't read like I used to enjoy to, and have no social life due to my health problems.

            I have lost many years of my life to health issues that started after my implants.  Before implants, I was a healthy mother of three, looking forward to my future years.  It is very hard to find medical care for my platinum illness, when doctors don't know what to do.

            To conclude, in 1996, Dow Corning advised the EPA of significant risk to their number two catalyst used in making gel-filled breast implants.  Dow's proprietary information lists chloroplatinic acid, one of the most hypersensitizing agents known to man, as one of the ingredients used in making breast implants.  The pro-implant lobby has been brilliant in convincing the FDA and the doctors the platinum in implants is harmless, much in the same way Enron was brilliant in their accounting methods or a time when the tobacco industries tried to convince everyone nicotine was non-addictive. 

            I ask that you do not approve -- do not give approval to devices that are not lifesaving and that leak silicone, platinum, and other chemicals into the bodies of young women and their children born after implantation.  Thank you.

            MS. TRACHTENBERG:  Good evening.  My name is Duchy Trachtenberg and I'm reading for Lynda Roth.  We have no conflicts of interest.

            I am Founder and Director of the Coalition of Silicone Survivors, a group of over 10,000 breast implant survivors.  I have run this group since 1991, and have heard from thousands of women with serious problems from Mentor's silicone breast implants.  I have a master's degree in social work.  I lost my job because of breast implant related health problems.  I also lost my health insurance.  I am basically uninsurable.  I was on SSI for my total disability.  I am also on Medicaid.

            In 1990, I was diagnosed with breast cancer.  I was in shock.  I trusted that my highly respected plastic surgeon was providing accurate information.  I soon found out many risks were not disclosed.  My Mentor implant hardened immediately, resulting in a great deal of pain and a very misshapen breast.  It spontaneously and silently ruptured within a few months.  It was removed soon after, but much of the silicone gel was not.  I had a second implant removed a year later and it had also leaked a lot of silicone.  My surgeon told me that silicone gel was inert and would not harm me.  I suffered from the pain and disfigurement, neither of which I was warned about.

            Within a year, I had extreme fatigue, problems with memory and concentration, visual disturbances, and fibromyalgia.  In 1994, I was diagnosed with lupus and there is no family history of lupus or related autoimmune problems.  The leaked silicone started to come out of my body.  I had small, hardened, rubbery lumps of silicone come right out of my forehead for three years, and I had silicone granulomas on both my arm and my leg. 

            I still have neurological problems.  My neurologists have written in their notes that they thought my silicone toxicity caused many of my health problems.  Silicone injections in the breasts were banned by the FDA because women had serious health problems and sometimes died from infections. A ruptured silicone implant is no more or no less than a massive silicone injection. 

            I believe many women could evaluate the risks of these devices, given enough time and adequate information.  Unfortunately, women who are told they have a life threatening disease, such as cancer, are often in shock and not in great shape to make these choices, especially when they are assured by their plastic surgeon that these devices themselves are safe, and that's exactly what my physician told me.

            Reports to our group still show very few women are truly informed of the risks prior to implantation.  Studies that have been conducted by the manufacturers are not run as true clinical trials.  Many women report to support groups that they have never been contacted for follow-up in their studies to check on their health.  Hundreds and thousands of women have registered and claimed injury from these implants in lawsuits and with the FDA.  Group leaders, like myself, have seen and hear about many problems from leaking silicone.  Most develop over time.  Studies that cover four years, inevitably, will not find these kinds of problems.  We all know from asbestos, dioxin, mercury, PCBs, and others, that diseases caused by exposure to toxins can take 15 to 20 years to manifest.  Why would silicone be any different?

            If the FDA approves implants based on four years of data, even though these products have been on the market for four decades, hundreds of thousands of more women will be exposed to these toxins.  No matter what the informed consent form says, they will believe that -- what their plastic surgeons tell them, that the implants are safe, and here's an example of this problem.  The two medical societies of plastic surgeons created a new website praising breast implants.  Instead of outlining the risks to patients, they praise the breast implants. The website tells patients to ask their doctors what the risks are.  Why not just list the risks on the website and let the women make up their own minds about whether or not they're valid?  The answer is simple: few would undergo breast augmentation if they believed the complication rates as calculated by the FDA.

            Women receiving implants today might not be ill for ten to 25 years.  What kind of future are we guaranteeing to them?  Do we want 17-year-old young women to have these implants?  You have a very important decision.  I hope you will consider all the women who have been harmed by their silicone gel implants before you make your recommendations.  Thank you.

            MS. CORDOVILLA:  Good evening.  My name is Constance Cordovilla, and I'm reading testimony for Virginia Rudolphi, who was too sick to be here today.  She and I have no conflicts of interest.

            My name is Virginia Rudolphi and I live in Campbell, Ohio.  When I was 22 years old, I got silicone gel implants.  I was told by my plastic surgeon that they would last a lifetime and I should never have any problems with them, and I was happy with my implants for the first ten years and did not have any problems or complications.  However, as we passed that mark, I seemed to have more and more problems that were progressively worse and much more difficult to treat. 

            This past fall, I got a terrible cough and x-rays showed scarring in the upper part of my lungs.  A CT scan revealed a number of granules in my lungs, and the pulmonary specialist did not want to do a biopsy, saying that it looked just like I had silicone in my lungs.  Upon hearing this, I went to have a mammogram to see if the implants were leaking.  I had to stop halfway through the mammogram because it hurt so badly.  I then had an MRI, even though it was extremely expensive, which also showed that there was no leakage.  But because I was experiencing so many health problems, I went to see a specialist who then conducted an ultrasound, and the ultrasound revealed that the silicone was leaking and had spread throughout my chest area.

            The doctor explained to me that not only was the silicone harmful to my body, but there were a number of other chemicals, such as platinum, that could also cause health problems involved with implants.  I immediately had the implants removed. It cost me $11,000.00 out of my own pocket, and while this was a lot of money for me, my health is priceless and I'm hoping that I will begin to recover soon.  The process of recovery, though, has been slow because of that silicone that remains in my body.  I can only think that had I been warned of the risks of silicone breast implants, I would have never gotten them.  I know several women who have had silicone implants over the last 15 years and all but one of them has major health problems.

            I find it particularly troubling that the manufacturers feel that four years of data can prove that these products are safe for long-term use.  After having my implants for the first nine years, I was a satisfied customer, but all of that changed after ten years.  For some women, it could take longer, and for others, the problems happen sooner.  Regardless, manufacturers should be required to conduct studies that show what can happen to patients with silicone breast implants for as long as my friends and I have had them.  If they did conduct such studies, they would find that silicone breast implants cause many serious problems and should not be approved.  I thank you.

            MS. AHEARN:  My name is Heather Ahearn. I am reading testimony for Rose Rust, who is too sick to be here today.  We have no conflicts of interest.

            My name is Rose.  I am 59 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 talked to a plastic surgeon who told me that they were safe and 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 asked if the implants could be making me sick.  He told me that they were perfectly safe.  I believed him. 

            I became more and more ill.  I had so much pain that I had to quit my job and was put on Social Security Disability.  Over the next few years, I went to many doctors, including the Mayo Clinic, but nobody could find out what was wrong with me.  I became almost bedridden.  My legs and feet burned, were swollen, and hurt so badly that I could hardly walk.  I was dizzy and nauseated.

            In August of 2002, I had my implants removed.  My left implant was ruptured and the surgeon said most of the silicone had leaked into my chest and lymph nodes.  She described it as a sticky mess.  She also removed the lymph nodes that had silicone in them.  She told me that there was probably silicone in my liver, lung, and brains.  The right implant was intact.  I have no idea how long the left implant had been ruptured.  I saw no difference in how they looked.

            Over the years, I have become unable to even take care of my home.  I spend many days in bed.  It is a struggle just to survive.  If it weren't for my doctor's assurances about the implants, I would have had them out many years ago and perhaps avoided much of the silicone leaking into my body.  I have now tested positive for platinum in my urine.  My neurologist is working to see if there is any way to remove any of the platinum from my body.

            I feel many of us have been guinea pigs. We are the evidence that silicone is not safe.  The FDA's research shows that implants will eventually rupture.  With silicone implants, you can have a ruptured implant and never know it, which is exactly what happened to me.  I am an anecdote, but I also fit the pattern of Inamed's own data showing silicone implants rupture and many women report aches all over their bodies.  But here you are again and the companies still have not provided the data requested by the FDA.

            It is too late to do much for women like me, but not for the next generation.  I implore you: do not allow silicone breast implants on the market until there are studies showing long-term safety. Don't ignore what has happened to us.  Thank you.

            MS. WILHITE:  My name is Kelli Wilhite and I am reading for Elaine Porte, who is unable to be here today.  We have no conflicts of interest.

            My name is Elaine Porte.  Twenty years ago, I decided that I needed breast implants to achieve the figure that I had always wanted.  I exercised religiously, but I thought I needed more and my doctor thought that having implants could help me achieve the look that I wanted.  He convinced me that getting implants was not a big deal.  He knew several women who had them and were very pleased with their appearance, and he happened to have a friend who was a plastic surgeon.  On top of that, the surgeon's wife and daughter both had implants.  How many times has this story been told?

            When I expressed my concerns about silicone, I was assured that my implants would be saline and not silicone.  Imagine my shock years later when I sent for information on the implants to find they were, in fact, silicone and not saline.  For the first three years, I was satisfied with my implants, but over the next years, I experienced a myriad of health problems that have cost me a fortune.  The implants hardened after only three years, and I never really enjoyed them after that. They never felt natural and I was always self-conscious about hugging people.  To me, it was embarrassing that people could feel the hardness of my chest.  It created intimacy issues between me and my husband, and I worried that if he held me too tightly, my implants might rupture and I cautioned him to be careful.

            Eight years after my surgery, I developed skin lesions, experienced severe sun sensitivity, and dry eye syndrome.  I tested positive for rheumatoid arthritis.  I have no sign of rupture, but plan to have the implants removed soon.  I could write volumes about why women should not get silicone implants, but that's already been done.  For me, the saddest part of my energy loss has not been able to give my family the attention that they deserved from me over the years.

            Young women don't see beyond the here and now and are constantly bombarded by media messages that make them easy prey.  Given the enormous health risks and the clear evidence provided by women like me who had implants for a long time, silicone implants should not be approved until they are improved.  I am convinced that as advisors to the FDA, you will make sure they do the right thing.  Thank you.

            DR. GLASBERG:  Good evening.  Thank you. My name is Scot Glasberg and I'm here to read the testimony of Dr. Henry Miller.

            My name is Henry I. Miller, MSMV.  I am a research fellow at the Hoover Institution of Stanford University, where my research focus is on public policy towards science and technology, including the impact of government regulation.  Prior to joining the Hoover Institution in 1994, I had been a research associate at the NIH, and then served for 15 years at the FDA as a medical officer, Special Assistant to the FDA Commissioner, and Founding Director of the FDA's Office of Biotechnology.

            I am troubled by the agency's record on silicone gel filled breast implants, the severe regulatory restrictions placed on these implants more than a decade ago because of alleged safety concerns, concerns that, although unfounded, virtually destroyed an industry and needlessly terrified tens of thousands of American women, were premature and unwarranted.  The maintenance of these restrictions in the face of vast amounts of countervailing data is incomprehensible and disgraceful.  The FDA's policy continues to deprive women, after consultation with their physicians, of the choice of making an informed decision about an important medical intervention for reconstruction following breast cancer surgery or for augmentation.

            The decision making by FDA concerning the availability of silicone breast implants has been improperly influenced by politics, plaintiffs' lawyers, and others with associated financial interest.  As I am keenly aware from my extensive work with the legal and regulatory standards applicable to products that require pre-approval, the agency is compelled to evaluate such products exclusively on the basis of objective, scientific data.  Yet, if one considers the extensive real-world experience with and scientific literature about these products, as well as the rigorous clinical data involving thousands of patients, it is apparent that these standards continue to be ignored.

            Silicone gel-filled breast implants have been studied and scrutinized more than any medical device in history, and hundreds of scientific studies conducted by leading research institutions in the United States and around the world reveal no link between these devices and long-term health effects.  The most persuasive evidence of their long-term safety was presented in the IOM Report in 1999.

            The forces against making these important medical devices more available to women have implemented a well orchestrated and long-standing campaign of misinformation and mischaracterization of the scientific evidence.  Their views do not reflect a good faith difference of opinion based on varying interpretations of the available data.  Consistent with legal standards and sound public policy, the panel and FDA must finally and unequivocally look beyond the unsupported claims of significant health problems with silicone breast implants by these groups and individuals, instead, focus exclusively on the science and patient's well-being.

            A regulatory determination prejudiced by unsupported conjecture and social/political agendas and not solely grounded in the significant available scientific evidence, will not only violate the law and constitute an affront to enlightened regulation, but will continue to be a disservice to women's health.  Thank you for your consideration.

            MS. HANSON:  Hi.  My name is Sarah Hanson and I'm reading the testimony of Valerie Lathrop, who could not be here today, and we have no conflicts of interest.

            My name is Valeria Lathrop and I live in Orinda, California, where I was implanted with silicone breast implants when I was 35 years old.  I was a perfectly healthy mother of three small children.  When my husband left me for another woman, I incorrectly thought breast augmentation would improve my self-esteem.  Instead, the hardening of my breasts and the chronic pain, both of which began immediately, worsened my life and my self-image.  Had I known that I would inevitably need to have them removed, I would have done so immediately.  The pain of the surgery, the disfiguring scarring it left, and the chronic discomfort were all a surprise.   No cautionary information of any kind was ever provided by my surgeon.

            From the first month of implantation, I gradually and increasingly became very ill.  I lost cognitive abilities and developed headaches, chronic fatigue, and recurring rashes.  I began to develop chronic bronchitis and pleurisy so painful that at times, I couldn't move.  Sleeping even became difficult.  Despite these symptoms, my doctor insisted that the implants were not the cause.  Also, I was so afraid of mutilation that I refused to consider that my implants could be ruptured.

            By 1997, I had full-blown fibromyalgia, numbness in my extremities, constant pain in my shoulders, chest and back, sleep disturbance, clinical depression, anxiety attacks.  A feeling of dread was increasing with the growing chill in my chest.  I couldn't afford any tests for rupture, but I found a women's support group that provided me with information.  I went to Denver to find a surgeon who promised to remove the toxic capsules, as well as the implants from my body.  So I was explanted in 1998.

            Both implants were ruptured with heavy damage.  My pathology report included fibrosis, inflammation, fragments of nerve tissue consistent with neuroma, calcification, and severe microbiological contamination.  Silicone was scraped off my lungs and from my armpits.  I had to stop wearing contact lenses due to the dryness and silicone extruding from my eyes and coating the lenses.  I have received medical care which sometimes made me feel even worse, but seven years later, all of the symptoms but the dry eyes seem to be gone.

            When I hear about the research showing an increase in suicide among women with implants, I can understand why, and despite the company PR, this is not an issue of choice.  Many women who have ruptured implants can't afford an MRI and can't afford to remove their implants.  Even if they can afford surgical removal, most are told by their plastic surgeons that removal will mutilate them.  So what kind of choice is this?

            If you approve silicone gel breast implants, millions of women will risk going through what I went through.  I urge you to require the companies to continue safety research.  Access to silicone implants should be restricted until safety studies provide them -- prove them to be safe for long-term use.  Thanks.

            CHAIRMAN CHOTI:  Thank you.

            DR. FRIEDMAN:  My name is Roger Friedman.  I'm a board certified plastic surgeon in the Washington metropolitan area, on the clinical faculties of both Georgetown and George Washington Universities.  I have no financial interest in any breast implant manufacturer.  I am a consultant for the Mentor Corporation, but that's not why I'm here at this hour.  I'm here to represent my patients.

            Based on the significant amount of scientific evidence and my own personal experience of performing breast augmentation and reconstruction for over 20 years, silicone breast implants are safe.  The long-term follow-up information previously requested by the FDA is now available, revealing no clinical correlation of connective tissue disorders, either defined or atypical, associated with silicone breast implants.  Therefore, I feel that the FDA should approve the use of breast implants without restriction so that women may have the opportunity to choose which implant is right for them.

            At the conclusion of the last set of hearings, the issue was that of long-term follow-up. In the past year, studies have been published in peer review journals addressing the issue.  The study by Breitling, which reviewed 190 Danish women with silicone implants for augmentation over 19 years compared to 186 women with breast reduction and 149 control from the general population, found no differences with the exception of breast pain found three times more frequently in the implant group, felt to be attributable to capsular contracture.  The study by Brinton, at the National Cancer Institute, of over 7,000 women with augmentation and average follow-up of up to 12 years with a maximum of 31.6 years, found no significant increase in connective tissue disease.

            The study by Lipworth and McLaughlin in June 2004, updating the studies published in 1999, and found the results consistent with the previous studies, revealing no increase in connective tissue disease in patients with implants.  The Fryzek study of Swedish women, 1,596 with implants, 2,496 who underwent breast reduction, the mean follow-up was 11 years with a maximum of 29 years, and, again, no association with connective tissue disease.

            There's also been the issue of informed consent.  In the state of Maryland, where I practice, there's been a detailed informed consent generated by the state that, by law, must be reviewed and signed by prospective implant patients, in addition to my own consent form.  In over ten years of providing this to all of my patients, I have never had a patient not undergo surgery based on that informed consent.

            I feel that patients are capable and should be allowed to make an informed decision as to whether silicone or saline is the best choice for them.  There is a difference in appearance, a difference in feel.  Not all patients are candidates for saline implants.

            In my private practice, performing over 100 breast implant cases per year, my patients have had an extremely positive experience with silicone implants.  I'm here to represent my patients, especially those who wanted to be present but wanted to maintain their anonymity.  There are mothers, several have children, who pursued breast augmentation to address the loss of breast volume after childbirth and breastfeeding, where the issue was not one of size, but restoring their original appearance.  I have also found in talking with patients that breast augmentation has improved their body image, self-confidence, and has increased their sexual satisfaction.

            Science has shown through long-term follow-up that there is no association of connective tissue disease.  I feel silicone gel implants should be made available for unrestricted use to all patients.  Thank you.

            CHAIRMAN CHOTI:  Thank you.  Why don't we go ahead and take a ten minute break and we'll organize the speakers here when they arrive?  Thank you.

            EXECUTIVE SECRETARY KRAUSE:  One quick thing: any speakers who are still here who haven't had a chance to talk yet, if you could please talk to AnnMarie.  AnnMarie, wave.  And get yourselves -- AnnMarie will organize you and have you come up and we'll see if we can get everybody through in the next hour or two.  Thank you.

            (Whereupon, the foregoing matter went off the record at 8:08 p.m. and went back on the record at 8:35 p.m.)

            CHAIRMAN CHOTI:  All right.  Why don't we go ahead?  Good evening.

            DR. GITTERMAN:  Good evening.  My name is Dr. Ben Gitterman.  I'm here to read testimony from Ms. Aileen Kiethley, a retired nurse.  I'm a board certified pediatrician and an expert in pediatric environmental health.  Neither Ms. Kiethley nor I have any conflict of interest.

            She wants you to know that better research is still needed in this area.  Speaking in general terms, there are no chemical -- no regulations for chemical contamination in breast milk.  Residue levels of many chemicals can be found in breast milk.  Quantitating them, however, is difficult and there are no programs to promote quality assurance.  Even if a very good laboratory generates results, there are no accepted normal or safe values against which to evaluate them.  Particularly, the long-term effects in children and in infants, just are not known about.

            Breast implants have been sold in the United States for 40 years, but no empirical studies were published until the 1990s.  Very few studies have been done on the impact of implants on breastfeeding.  The Institute of Medicine Report in 2000 on breast implants summarized studies that found that any kind of breast surgery, including breast implant surgery, makes it at least three times more likely that a woman trying to breastfeed will have lactation insufficiency or an inadequate supply of breast milk.

            As I said, there is clear evidence that chemicals from breast implants can get into breast milk.  In 1990, a silicone breast -- excuse me, the silicone gel breast implant that was covered with polyurethane foam was voluntarily taken off the market when FDA studies found TDA, a known animal carcinogen, in women's breast milk.  The foam broke down into TDA in the women's breasts and the TDA was in her body and in her breast milk.  The polyurethane covered implants were extremely popular and thousands of women probably still have them in their bodies.  Although not the kind of implants under consideration by the FDA this week, the fact that the implant shell contaminated breast milk is very relevant.

            Last year, Professor Susan Maharaj from American University reported that much higher levels of platinum were found in the urine, blood, and breast milk of women with silicone breast implants compared to women who did not have implants.  It was also found in the offspring of children who had been nursed by women with silicone breast implants, but not in children born prior to the mother getting breast implants.  What isn't so clear is how often that happens, exactly what chemicals get -- exactly what chemicals from gel breast implants get into breast milk, and what health risks might result.  Impacts are needed.  Where is it and why hasn't that research been required up to date?

            We already do not know much about the impact of lead in breast milk.  Lead does not come from breast implants at all, but we do not know that even though that is a well studied chemical on its impact in children, the lead in breast milk is not understood.  The impact, therefore, of metals in breast milk that come from implants has not been answered at all because the questions have not adequately been asked.  Of the few studies that have been done, the sample sizes are very, very tiny.  Similarly, studies of sick children whose mothers have implants, rather than a -- than a random sample don't really tell us what we need to know.  Breast implants should not be approved by the FDA until adequate studies are done in this regard.  Thank you.

            MS. TAYLOR:  My name is Virginia Taylor. My daughter is Shannon Scott, she testified about three hours ago.  Shannon is 23 years old and is bedridden 95 percent of the time.  I assist her with the most minor aspects, from brushing her hair, helping her dress, to grocery shopping and housekeeping.  Prior to implantation, she was attending UCSD, majoring in biotechnology with a 3.9 GPA, Honor Roll student, and was working full-time.

            At the age of 20, in perfect health, she chose to have breast augmentation.  Dr. Dennis Ogden (phonetic) performed the augmentation surgery on her, enrolling her in the Mentor adjunct study clinical trial as a reconstructive patient, citing chest wall deformity due to a pea-sized benign cyst that was removed from her left breast when she was 18 years old.  In reality, the cyst removal left a slight blemish only.  She has never had any deformity. 

            The consent form states, "Close monitoring/medical treatments as needed in the next five years."  During the consultation, Dr. Ogden stated, "They're perfectly safe."  He performed a closed capsulotomy in less than a year after her implantation.  In June of 2003, she was hospitalized, lost her job due to illness, received disability for one year, and has applied for Social Security benefits, of which has taken over a year in processing.  We filed an appeal and have written congressmen and senators.  She has no income.  We have countless emergency room visits.  My child's health has been adversely affected since implantation of silicone.

            Last fall, Dr. Ogden sent Shannon a letter resigning as her doctor, giving no valid reason and no referral.  We've served Scripps' IRB a letter requesting assistance, copies were sent to the FDA and to the U.S. Department of Health and Human Services.  We spoke with Mentor's patient service representative whom stated, "We have no record of the doctor's letter of resignation, the closed capsulotomy, hospitalization data, or records of illnesses."  To date, there has been no communication received.

            There has been a severe lack of medical protocol in Shannon's case.  How many patient enrollment studies such as my daughter's are occurring daily where augmentation patients are being falsely enrolled as reconstructive patients?  The following problems are occurring: doctors that do not follow the protocol are not removed from the study, nor are they reporting all their patients' data as a part of the study; study patients who need explantation are out of luck; medical treatments are not being provided as promised. 

            The FDA is supposed to protect us all.  Monitor this study, make sure health problems are reported, and the patients are not harmed.  Public safety is at risk if enrollment criteria/erroneous data is inadequately/inaccurately collected are not submitted.  It is a time limited study.  Efforts at any level have been negligent in reporting data of her case to the FDA, causing adverse effects on this patient study.

            CHAIRMAN CHOTI:  Would you sum up for us, please?

            MS. TAYLOR:  I ask the FDA to please help protect all of our daughters.  Thank you.

            CHAIRMAN CHOTI:  Thank you.

            DR. NEWBURGER:  Question.

            CHAIRMAN CHOTI:  I'm sorry; a question. Yes, Dr. Newburger?

            DR. NEWBURGER:  Ms. Taylor?

            MS. TAYLOR:  Yes, ma'am.

            DR. NEWBURGER:  If I understand you correctly, you're saying that there isn't a record anymore of your daughter's consequences with this trial?  That she's been removed from the surveillance population?

            MS. TAYLOR:  I believe she has never been monitored.  Mentor had no record of any of her hospitalization data, of any of the illnesses that she's reported to the doctor.  The doctor has resigned as her doctor, giving no referral, and, no, there isn't.

            DR. NEWBURGER:  And she was enrolled through an IRB?  Through an IRB?

            MS. TAYLOR:  Yes.

            DR. NEWBURGER:  And has the IRB responded to you to help you?

            MS. TAYLOR:  No.  We sent the letter in January and I had it served.

            DR. NEWBURGER:  So if we don't have her reported as part of the database, then that's our problem, but getting her care is something that you'd have to --

            MS. TAYLOR:  That is my question, is exactly the methodology of the record taking.  If it pops up on a computer screen at a plastic surgeon's office, is it time to monitor the patient?  Or are the symptoms reported and she -- every time she went into her plastic surgeon, he said, "Oh, you just have the flu.  Please go home," you know.  Her symptoms were -- have been totally ignored and she's so frail, and the medical community is very unaware of silicone toxicity symptoms that occur.  She was perfectly healthy.  She had everything going for her and she just didn't because she -- she -- her fiancé, they've been together since she was 16.  She wanted to only do it for her own self and I told her that God gave her every gift, but you only live once, and it's your life and you have this choice and I don't want you to be 50 and turn around and say, "Gosh, I wish I did that when I was 20."

            DR. NEWBURGER:  Thank you.

            CHAIRMAN CHOTI:  Thank you.

            MS. TAYLOR:  Thank you very much.

            CHAIRMAN CHOTI:  Good evening.

            MS. COLLINS:  Hello.  My name is Gail (phonetic) Collins, and I'll be reading testimony for Samantha Berk, who could not be here tonight.

            My name is Samantha Berk.  I'm 35 years old and have used both saline and silicone gel breast implants over the past six years.  I was trained as a nurse, though I'm not currently practicing as one.  I think this is germane, however, because my nursing experience gave me a heightened sensitivity to medical safety issues.  I did not decide to have breast augmentation without a great deal of research and consideration.  I'd like to inform the panel about my personal history with both types of implants.  I do not have any financial interests in Inamed, Mentor, or their competitors.  As I was not able to be here today, I asked for this testimony to be shared with the panel.

            In 1999, for cosmetic reasons, I opted to undergo breast augmentation using saline implants.  My results with this device were acceptable, but I had continuing minor complaints.  You could feel the implants' ridges through my skin, my breast seemed unnaturally firm, and the devices never adhered to the chest wall properly.  They were always loose inside the breast pocket.  I followed up on these complaints with my doctor, and after three, hour long sessions where we reviewed the potential risks and complications, I decided to have my saline implants removed in April of 2003 and replaced with silicone gel devices.

            In talking with my doctor and in comparing the two types of devices in her office, it was clear to me that the gel implants had a more natural feel and seemed like they would fill the interior of the breast without irritation of the hard ridges.  The implant itself really felt softer and more like natural flesh than a device.  As a nurse, I was very attuned to the risk inherent in any surgery or use of medical devices, and I did my own research about the safety of silicone gel implants.  In my consultations with my doctor, she actually read out loud a 12-page disclaimer about the silicone gel implants with me.  She even told me of the negative claims about silicone implants that had been made in the past, but remained unproven by science.  Her professional opinion was that the silicone gel devices were safe, felt more natural, and accomplished the goals of augmentation the best. My opinion, after reading the studies, was the same.

            I also discovered in my own research that was all around the world, they've used silicone gel implants.  Nobody uses silicone -- sorry.  Nobody uses the saline implants because they simply don't do the job as well.  The only reason women in America are denied the best device for augmentation is because it has been unfairly demonized by emotion, without regard for fact.  My perception is that silicone implants are in the situation they are because people always want to find something on which to blame their misfortunes.

            Silicone devices are used throughout medicine for reconstruction, in hip replacements, heart valves, etcetera.  There are no billion dollar class action suits or media outcries when silicone devices are used to save people's lives, but because breast implants are elective, not lifesaving, these devices have been used as an easy scapegoat, and in my view, a lottery for women who have had health problems after undergoing surgery.  This, despite the fact that none of the studies that have been done have found statistical validation to back up the claims that these devices cause any negative impact on health.

            CHAIRMAN CHOTI:  If you could summarize for us, please.

            MS. COLLINS:  I hope this panel will look at the science, not the emotionalism, and agree that women should be allowed the freedom to make the better choice for them.  Thank you.

            MS. PENDLETON:  My name is Judy Pendleton.  I'm 64 years old and a grandmother of five.  I'd like to thank the panel for taking the time and taking into consideration my experience with silicone breast implants.  I also want it to be known that I am receiving no compensation from any group in any way for my testimony.

            When I was in my early 40s, I had a subcutaneous bilateral mastectomy.  Up until that time, I kept finding lumps in breasts which had to be biopsied.  Each biopsy was another scare, another what if situation.  I finally decided that I was sick of these constant scares and tired of having my breasts cut up every few months.  Prior to my mastectomies, I discussed various options with three surgeons and a plastic surgeon.  At that time, I chose to have silicone breast implants.

            I had my silicone implants for over 20 years without a problem.  About two years ago, I felt a small pain in my chest.  I went to my doctor and I had an MRI.  My doctor said that the MRI showed that the implants might be leaking and he suggested the we remove them.  Again, we had a long discussion about the pros and cons of the procedure. I listened to the risks and the benefits, but I really did not have to think twice.  I'd been happy with my old implants for over 20 years and I decided to get another pair of silicone implants.

            After my surgery, my doctor told me that the old implants were not leaking.  When I had had my first procedure, I knew the implants would not last forever, so I was not surprised that I had to go back for a follow-up procedure many years later. I was surprised, though, to find out that after 20 years, my old implants were in such good condition.

            I have not had any problems with my new implants.  I had the option -- having the option of implants enabled me to have a mastectomy.  Had I not had the reconstruction option, I might not have had this procedure which has given me considerable peace of mind because I do not have to worry about finding any more lumps in my breasts.

            In the two years following my second procedure, my doctor asked me to speak with other women facing the choices that I had made.  I have shared my experiences with mastectomy and breast reconstruction.  I have been able to tell them how happy I am with my new breasts and to reassure them about the procedure.  I'm very grateful that my doctor was able to give me more than one option.  The availability of silicone implants gave me the opportunity to decide what was right for my body and my lifestyle.  I'm very happy with the choice I made over 20 years ago and also two years ago.  I think that breast reconstruction is a very personal choice and women should be offered all the safe choices that are out there so they can make the decision about what is right for their own body.  I'm glad I had that opportunity.  Thank you very much.

            MS. TAPSCOTT:  My name is Mindy Tapscott and I am 44 years old and I'm a bilateral breast cancer survivor.  I would like to thank the panel for taking into consideration my experience with silicone breast implants, and I also want it to be known that I'm receiving no compensation from any group, in any shape or form, for my testimony.

            I was first diagnosed with breast cancer in 1989, at the age of 28, and I knew I would be seeking reconstruction of my left breast following mastectomy surgery.  After discussions with my surgeon, I'd elected to have the reconstruction with a silicone gel-filled breast implant.  I felt this option looked more natural and had an easier recovery period than the other reconstruction options that were available to me.  My surgeon provided and asked me to review and consider the insert that the manufacturer includes with each implant.  In addition, she reviewed with me the potential complications associated with silicone implants, including capsular contracture and rupture.  She informed me that some women are more prone to complications than others and that she could not reproduce what God gave me.  I nonetheless felt comfortable with my decision.

            At my initial post-surgical follow-up, my surgeon advised me that massaging my breast would help reduce the risk of capsular contracture, but I must confess, I didn't follow through with that recommendation and about one year after my first implant surgery, I experienced significant capsular contracture of my left breast.  I decided not to do anything about it until about ten years later, in 1989, when my implant was replaced.  I requested it be replaced due to the increased size of my right breast, resulting from two pregnancies.  After the procedure, my plastic surgeon specifically told me that the first implant was intact, that the polyurethane coating was still in place.  It had not disintegrated.

            One year later, the new implant also became encapsulated because I again chose to ignore the instructions about massaging.  That same year, I received a diagnosis of breast cancer of my right breast.  Despite the complications I'd experienced with my first implant, I also elected to have a silicone gel-filled implant inserted after my second mastectomy.  This too became encapsulated shortly thereafter.  Again, I ignored the massaging instructions.

            In 2003, I decided -- January -- I decided to have both implants replaced once again.  The latest procedure produced a terrific outcome and I've had no trouble at all since that time.  Despite my history with local complications and the number of re-operations I've had, I still consider silicone breast implants the option of choice for me following my breast cancer.  When you're diagnosed with breast cancer, you feel a loss of control because you don't know what you did to get the disease, and having choices made me feel like I got some of that control back.

            The many operations I've had don't bother me at all.  It was all worth it.  Silicone implants have simplified my life.  I'm a mother of three small children now and I can barely remember my purse when I leave the house, let alone a breast prosthesis.  I don't have to worry if my breast is in before I answer the door.  I never have to worry about my prosthesis falling out or coming out of position.  Silicone gel implants look and feel most like me and allows me to get on with the business of living.  Thank you.

            MS. THOMPSON:  My name is Yvonne Thompson.  My expenses to this conference were paid by Inamed.  I'm 59 years old, wife, mother, homeowner, registered voter, and legal secretary.  I make every effort to live a healthy lifestyle, spending eight to ten hours a week in a gym, and I'm careful with what I eat.

            For the past 20 years, I have been watchful of lumps forming in my breasts and have had several procedures called lumpectomies, which prove to be benign.  Five years ago, my doctors discovered cancer in my left breast.  Upon surgical examination, it was deemed necessary to remove a large portion of the breast, which, by the way, they did not have much to work with after that and then we went into the process of deciding to have reconstructive surgery or not.  My husband, who was at the time recovering from his own bout with prostate cancer, was and is very supportive of me.  I know that my disfiguration was of no consequence to him; however, we live a healthy lifestyle, as I mentioned, with a pool and other activities which would expose my disfigurement to everyone.  Additionally, I work in a very professional environment and I'm expected to maintain a professional appearance and not that of damaged goods.  Incidentally, I don't spend all this time in the gym not to have the damaged goods portion of my body look as well as what I determined to try to make the rest of my body look.

            The procedure was a success.  The cancer was gone.  When the opportunity arose to repair the cosmetic damage done by the surgery, we discussed it at home and decided the medical team, in whose hands I had the great good fortune to be, were the best and had my welfare as a top priority.  The decision was made to proceed with reconstructive surgery.  As you may know, a radiated breast will not support a prosthesis.  A transflap (phonetic) procedure was performed, bringing tissue from my abdomen to the affected breast.  My right breast was in need of balancing, and the implant used was deemed to be the best for me.  The alternative implant would have been visible in my case based on my particular physique.  With the exception of some expected scarring, my recovery is complete.  I'm very pleased with the results, and, in fact, have been an inspiration to a friend who had a mastectomy and who spent years wearing a cumbersome and uncomfortable bra before discovering the comfort and appearance of the silicone implants.

            I certainly am glad that my representatives in government are attentive to the needs of their constituents, but I believe that there should be some limitations on their reach.  I think that medical decisions are best left to informed patients and excellent doctors.  Thank you.

            DR. WOOLEY:  Good evening.  I'm Paul Wooley.  I'm Professor of Orthopedic Surgery, Immunology, and Biomedical Engineering at Wayne State University.  My colleague, Michael Harbut, is unable to attend the panel meeting and has asked me to read his testimony.  It is as follows.

            My name is Michael Harbut.  I am a professor at the Wayne State University School of Medicine and I'm a physician, board certified in occupational medicine.  I have no conflict of interest or financial ties to these manufacturers or their competitors.

            Physicians in my specialty understand the effects of industrial chemicals on the body.  Industry claims that platinum has a zero-valent state and doesn't pose a toxic risk to women.  This isn't just misleading; it's wrong.  Platinum compounds have been employed in manufacturing as catalysts in silicone breast implants.  The platinum content of the average sized silicone gel implant, surgically placed in the body, far exceeds the minimum initial industrial exposure threshold for airborne platinum.

            For 20 years, the manufacturers have also been aware that platinum may contribute to the autoimmune reactions documented in the sick women with breast implants.  In addition, manufacturers should have investigated the probability that platinum can be released from the device into breast tissue, a phenomenon that has been established by outside research.  These facts present nagging questions about silicone breast implant safety that cannot be dismissed.

            One industrial chemical, hexachloroplatinate, is a platinum salt found in the catalytic converters of automobile exhaust systems and in the silicone gel, an elastomer of breast implants.  It is used to catalyze the silicone monomer to polymer reaction.  The occupational medicine literature states quite clearly that at no time should a worker come into contact with a liquid or solid containing platinum salts.  Workers at the CDC found SBI leeching of platinum into normal saline.  Lykissa reported leeching into a more physiological medium and the AFIP (phonetic) and Maharaj have found significantly more platinum salts in SBIs than previously reported.

            Platinum salts are the most potent sensitizers in the literature.  They are found in SBIs in a range beginning at about 1,500 times that allowed in the air of a factory by OSHA.  Patients exposed to platinum salts can develop asthma, dermatitis, pruritus, and hypersensitivity responses.  Platinum salts also have GI effects, and in incredibly minute amounts, will poison mitochondria in the cerebrum.

            Lastly, I have provided this information in the form of a petition to the FDA to warn patients contemplating the placement of platinum catalyzed devices as they may be at increased risk of developing a hypersensitivity response.  Based on these results, I strongly urge the panel to not approve the silicone breast implants.  Thank you.

            MS. ERICKSON:  Good evening.  My name is Jan Erickson.  I'm reading testimony for Evon Peterson.  She has no conflict of interest and neither do I.

            My name is Evon Peterson.  I am a registered nurse.  I had silicone breast implants for reconstruction following bilateral mastectomies. The doctors acted as if reconstruction was something I had no choice about.  It was expected.  They never informed me of any risks or complications I might experience.

            A few weeks after reconstruction, the firmness and contractures began.  The shape of my breasts became distorted and the surrounding tissue became inflamed.  Lying on my right side or fully using my right arm was restricted.  I experienced searing pain in my back and neck.  After that, more obvious systemic symptoms developed.  At age 45, I was totally disabled and could no longer work or engage in social activities.  I experienced profound fatigue, insomnia, seizures, tingling and numbness of the extremities, dizziness, nausea, skin discoloration and hardness, joint pains, chemical sensitivities, and balance disturbances.  I felt like I was in a mental fog.  I had contemplated suicide, as many in my condition have, as a way to stop the pain.  I know if I had kept the implants any longer, I would have committed suicide.

            Prior to explantation, I faced a paradox.  I was too ill to have surgery and too ill not to have surgery.  I'm 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.  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 granulomas.  The first symptoms to appear after getting implants were the first to diminish when the implants were removed.

            Despite living with multiple autoimmune symptoms, my health has improved from about ten percent functioning to 60 percent functioning.  Considering that I have also aged ten years, I am delighted.  One of the worst aspects of this experience has been the continuing denial by implant makers and plastic surgeons that implants can cause health problems.  They failed 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.

            Four years worth of data is not long enough to demonstrate long-term safety of breast implants.  Pease require unbiased, long-term studies before any decision is made about approval of silicone breast implants.  Thank you.

            MS. CHARNEY:  Good evening.  My name is Lydia Charney.  I wish to thank the panel for the opportunity to present my testimony and I also wish to state that I have no financial responsibility and/or connection with any sponsors or competitors.

            I am a breast cancer survivor.  At the age of 29, I was diagnosed with breast cancer and underwent a modified radical mastectomy.  I chose to have my reconstruction done in conjunction with the mastectomy and a saline implant placed.  Saline was the only type of implant available to me at that time.  The saline implants were hard, shapeless, and lacked any contour.  It felt as though I was lying on a softball when I slept.  My surgeon at the time even commented that he was not creating a breast; he was creating a mound.  The saline implant filled the space where my breast once was, but it never felt anything like a breast to me.

            Eight years after my first cancer, I was diagnosed again with cancer in my other breast.  This time, I decided to become more involved in my treatment.  Many hours of research and physician consultations led me to choose the silicone implant with the second cancer.  I also chose to have my original saline implant removed and replaced with a silicone implant during the same operation. 

            The silicone implants have allowed me to have reconstructed breasts as close to my real breasts as I could hope.  The silicone implants are softer.  They have contour, shape, and volume.  The silicone implants make me look even, natural, and complete.  I feel fortunate that I had a choice between saline and silicone implants, which was available to me after my second cancer was diagnosed.  I believe in my heart that without silicone implants, I would not feel like a complete woman, as I do today.  Thank you, and please give due consideration to my testimony as you debate this issue.

            DR. SHESTAK:  My name is Kenneth C. Shestak, and I wish to thank you for allowing me to appear tonight to comment on my experience with silicone gel implants.  I have no conflict of interest and receive no compensation for this testimony.  I'm currently a tenured professor at the University of Pittsburgh, and have served as the Chief of Plastic Surgery at Magee Women's Hospital in Pittsburgh for 18 years.  Over that time, I established and now run a very busy breast practice. I've published more than 50 peer review articles in the medical literature, and recently, my single authored textbook on re-operative plastic surgery of the breast will be published by Williams & Wilkins this year.

            Over the past six years, I've been a participant in both the adjunct study for silicone filled breast implants and core studies designed to collect prospective data on patients following silicone implant placement.  To date, I've placed 261 implants in 169 patients.  I've carefully examined each patient every six months following surgery.  These third generation silicone breast implants have been far superior to previous silicone implants and to saline implants from the standpoint of breast shape, mobility, softness, and overall natural feel characteristics.  There have been no instances of silicone implant rupture and no known silicone extravasations in any of these patients.  The rate of objectionable capsular contractor has been five percent.  There have been 16 re-operations done in 15 patients, for a re-operation rate of nine percent.  There have been no instances of patients complaining of symptoms outside the area of the breast, namely any problems with the skin, joints, or constitutional symptoms.  In this patient group, 165 out of the 169 patients are happy or extremely happy with -- following the outcome, for a satisfaction rate of 97.6 percent.

            I've always prided myself on being a doctor who does what's best for the patient in all situations.  Clearly, health and safety concerns raised regarding silicone filled breast implants were a source of concern for doctors and patients alike.  Safety issues were analyzed in two large independent reviews done in the United Kingdom, the Independent Review Group, and in the United States, the Institute of Medicine Report, and both reviews concluded there are no health risks posed by the presence of silicone breast implants.

            During the mid 19 -- during the 1990s, I used saline implants exclusively for reconstruction. The results I was able to achieve left a lot to be desired from the standpoint of symmetry, shape, and softness.  I felt very badly for the patients.  This all changed approximately six years ago in my practice in a very dramatic way, with the use of the currently available silicone breast implants.  I'm now able to consistently achieve what I consider to be very good results for patients undergoing single-side or bilateral breast reconstruction.  These devices have given me a whole new enthusiasm for the current state of the art of breast surgery, which includes silicone gel breast implants.  It's especially timely given the fact we're seeing more patients for bilateral prophylactic mastectomy. 

            These third generation silicone implants provide such patients with a real hope that we can provide them with good results on a consistent basis.  I firmly believe that such results are delivered within the context of patient safety, the lowest ever percentages of complications, and no discernible evidence of producing harm to the patients in any way.  Thank you.

            CHAIRMAN CHOTI:  Dr. Shestak, may I ask you a question, please?  Do you -- in your practice, do you recommend routine imaging on your patients?

            DR. SHESTAK:  I follow them with a combination of physical examination and imaging done at periodic intervals following implantation.

            CHAIRMAN CHOTI:  What kind of imaging?

            DR. SHESTAK:  It's either a mammogram and sonogram done in combination or MRI imaging.

            CHAIRMAN CHOTI:  And if you saw an asymptomatic leak on MRI, would you recommend removal of the implant?

            DR. SHESTAK:  I reco -- I routinely recommend removal of an implant that -- whose shell is not intact and I'll remove the implant and exchange it.

            CHAIRMAN CHOTI:  But in your practice, you haven't had a single one with a silent leak identified on imaging?

            DR. SHESTAK:  Over the past six years, we have not.

            MS. NORSIGIAN:  Hello again.  I'm Judy Norsigian, and this time, I am reading testimony on behalf of the American College of Women's Health Physicians, specifically for physicians who could not be here because they're caring for patients: Katherine Patterson Neely, Janice Werbinski, JoDean Nicolette, Justina Trott, and Barbara Haeckler.  Excuse me, that's five.  American College of Women's Health Physicians is committed to advancing women centered healthcare.  They have no conflict of interest.

            As we consider the case of silicone breast implants, let us remember how many physicians routinely prescribed hormone replacement therapy, thinking that we were providing care that was beneficial.  After well-designed studies were completed, we learned that we had been wrong.  We need to make sure that we don't repeat this kind of error with breast implants, and this meeting is your chance to do just that.

            Silicone breast implants may or may not cause all the disease and symptoms they're accused of tonight.  We don't know because adequate research has not been done.  We should not approve these devices when reasonable and safe alternatives exist until rigorous safety standards have been met.  Last year, more than 300,000 women and teenagers underwent breast implant surgery for augmentation.  The number has more than tripled since 1997.  However, many of these women are replacing old implants that have broken or cause problems.  Some women report as many as ten or more surgeries as their implants are replaced over the years.

            All breast implants will eventually break.  When silicone gel breast implants break, there are often no symptoms, so accurate estimates of rupture rates depend on MRIs.  In a study conducted by FDA researchers, most women had at least one broken implant within ten years and the likelihood of rupture increased over time.  The women in the FDA study had not had their implants removed, did not know that their implants were broken, and were not seeking help because of illness or implant concerns.  Despite the fact that these women were satisfied customers not seeking medical care, MRIs found that silicone had migrated outside of the breast capsule for 21 percent of the women.  Most were unaware that this had happened.

            Numerous studies have shown silicone leakage into the scar capsule surrounding breast implants, even for implants that are not ruptured.  More worrisome, researchers have found silicone in the lymph nodes of women with breast implants, which can then migrate to other organs.  Silicone in the lymph nodes can be -- only be removed by removing the lymph nodes.  Silicone in organs such as the lungs, liver, and brain cannot be removed.  The health risks associated with migrated silicone are unknown; however, case reports have indicated fatalities and serious health risks when liquid silicone injected in the breast migrated to the lungs or other organs.

            A study published by the Royal Academy of Medicine in Scotland found that a woman with a broken silicone gel implant in her calf was coughing up silicone identical to the kind in her implant.  This has potentially serious implications for women with leaking breast implants.  Free silicone in the body has been suggested to increase the risk of autoimmune disease and connective tissue disease.  Studies from the 1990s tend to show no increase in risk, but more recent studies suggest an increased risk of autoimmune symptoms and possibly in diseases.

            Scientists at the NCI found a statistically significant increase in reported connective tissue diseases among breast augmentation patients, but also found that many of the women made errors in their self-reported diagnoses.  Their study included women who had breast implants for at least seven years.  The findings suggest that there are increased symptoms among women with breast implants, but it is not clear if there is an increase in specific diagnoses.  As a result, the researchers concluded that larger studies would be necessary to draw conclusions.

            Prior to the NCI study, most published research that had focused on autoimmune and connective tissue disease studied women who have had implants for a relatively short time, ranging from a few months to a few years.  These studies are the basis for a report on implants by the IOM, a report by Judge Pointer's scientific panel, and a meta-analysis published in the "New England Journal of Medicine" regarding the lack of evidence that implants cause systemic disease.  All three of these reports are based on the same 17 to 20 epidemiological studies that were published prior to 1999.  Since many connective tissue and autoimmune diseases are relatively rare among young women, and most take many years to develop and be diagnosed, these studies are not designed to answer questions about long-term safety.  They are underpowered and include substantial numbers of women who had implants for just a few months or years, with too few women who had implants for ten years or more.  Worse yet, some depended on hospital records for diagnoses.  Obviously, most women with autoimmune diseases or symptoms are not treated in hospitals.  Careful scrutiny of the research indicates in increase in symptoms in many studies, but is primarily in the studies where all the augmentation patients had implants for at least six years.

            Please note that the independently funded studies tend to focus on women with implants for longer periods of time and often show increased risks that are not found in industry funded studies. Particularly when we have increasing numbers of healthy women and teens electing breast augmentation for purely cosmetic reasons, we have a duty to ensure that they do so safely.  We need adequate long-term studies, with reasonable dropout rates, and ten to 15 years of follow-up before we will have the answers we need.  For now, if there are not sufficient data to demonstrate safety, the American College of Women's Health physicians recommends that you vote against the approval of silicone implants. Thank you on their behalf.

            MS. CONNOR:  My name is --

            CHAIRMAN CHOTI:  I'm sorry; excuse me.  A question for you from Dr. Miller.

            DR. MILLER:  I was wondering if you -- if you could comment -- if you have any -- I don't mean to put you on the spot here, but --

            CHAIRMAN CHOTI:  Would you turn his microphone on?  Excuse us.

            DR. MILLER:  If you could design the ideal study, if you had limitless resources and could design the perfect study to resolve all the questions you just raised, with the right power and the right duration, what would that study look like?

            MS. NORSIGIAN:  I can't answer that for you now, but, actually, I've seen some recommendations, some actually by FDA scientists in the past.  This has been looked at for about 20 years, and I remember about 12 years ago, somebody suggesting something that I don't think was ever done but was designed to do that kind of thing.

            Obviously, we're not going to get all of the answers with one study.  There'll be more than one study, but I think it is -- the point's been made throughout the day that we've had a lot of time to look at some of these questions and haven't really taken the time to do perspective studies, carefully following women, watching dropout rates, having enough women in there with ten years use or more.  Those are the kinds of things we could have done and really still need to do.  I know it would take money, but it's not more money than we've spent on other studies.

            CHAIRMAN CHOTI:  Yes.

            MS. CONNOR:  My name is Holly Connor and I am here to testify on behalf of Carolyn Stone, who could not be here this evening.  We have no conflicts of interest.

            My name is Carolyn Stone and I am from Tucson, Arizona.  When I was 25 years old, I was implanted with silicone gel breast implants following a mastectomy for a precancerous condition that I had since I was 13 years old.  My plastic surgeon never warned me about any risks or complications from silicone gel implants.  The only advice he provided was that I would need to seek medical attention immediately if the implants had ruptured.  Unfortunately, I was in a terrible car accident six weeks later and one of the implants broke on impact.  I had the implant replaced.

            Since I had the ruptured implant removed right away, I thought that there would be nothing to worry about in terms of further complications; however, my health began slowly deteriorating.  I was diagnosed with chronic fatigue and autoimmune problems.  My health deteriorated to a point where I could no longer work or live my life the way I was accustomed to living it. 

            By the time I was 35 years old, my health became so poor that I decided to have an explantation.  Because I was unable to afford the cost of yet another surgery, I went to the hospital to have them removed as an indigent and was badly disfigured as a result.  I went on a quest after my final surgery to improve my health and I am still, many years later, on this same quest.

            My health has recovered slightly and I believe this to be a result of the removal of my implants, but I continue to suffer from a number of health conditions and I suspect that I will be trying to regain my health for the rest of my life.  I was not prepared for the effect that this entire experience with implants has had on me, physically or mentally, but I have to come to grips with it.

            Last fall, five silicone breast implant manufacturers agreed to pay the federal government millions of dollars to compensate for the costs of caring for women made ill by silicone breast implants.  This was a settlement the Department of Justice pursued on behalf of the U.S. Department of Defense, the Department of Veterans Affairs, the Indian Health Service, the Centers for Medicare and Medicaid Services, and the Department of Health and Human Services, the very agency that houses the FDA. It is mind boggling that the FDA would be here today considering Inamed and Mentor's requests to put these same harmful products back on the market without restriction.  It will only cost the U.S. taxpayers many more millions of dollars as these harmful products will continue to make women sick.

            I implore you to make sure the FDA stands by its decision to require that long-term data be collected on these devices, to address long-term safety concerns.  Thank you.

            MS. NAGELIN-ANDERSON:  I'm Liz Nagelin-Anderson and I have no conflicts of interest.  In a previous job, I was in charge of a health hotline and I heard from many women with problems -- who had problems with their breast implants.  The risk that most concerns me is violent rupture.  Some seem to think that as long as there are no symptoms, there is nothing to worry about; but meanwhile, silicone can leak into the lymph nodes and from there, travel throughout the body, as shown in the FDA's literature review.  We don't know what the health effects are, but we know that silicone can't be removed once it's in the lungs or the liver.  We know that women who are sick tend to get better if their implants and silicone are totally removed, and tend not to if it's not, if it's left inside their bodies.

            Inamed's new data found a low rupture rate among augmentation patients, about three percent, in what they called four years, but it was really three years because MRIs that were used to detect rupture were done in the first and the third years.  And notice in the Inamed data that the rupture doubles from year to year.  If that rate continues, a 3.4 percent rate at three years would be 56 percent at seven years.  The rate for reconstruction patients is even worse: 20 percent after the three-year MRI.  Inamed claims the problem is just one implant style, but if that's true, why has it taken so many years for them to notice the problem and why haven't they recalled those implants?

            Mentor's data indicate a much lower rupture rate, but their patients had implants for only two to three years.  They all had their one-year MRIs, but many did not have their three-year MRIs, so no wonder the rupture rates are so low.  And Mentor did something else odd.  A woman had her implants removed and not replaced.  She was taken out of the study and not counted.  Obviously, a woman who has her implants removed and not replaced within three years isn't happy with her implants, and it's likely they either broke or caused her some kind of complication.  Those women should be studied, not removed from the study as if their problems never happened.

            So what are the health risks of rupture and leakage?  Well, the FDA did an excellent study indicating that women with extracapsular leakage are more likely to report fibromyalgia and several other connective tissue diseases.  But for some reason, that study is not mentioned in the FDA's summary.  The FDA did, however, summarize a Danish study of rupture which concludes that women with extracapsular leakage are not more sick than other women in the study, but that's not exactly true.  They were twice as likely to report pain and fatigue, and these differences were not statistically significant, but the sample size was tiny, just 23 women.  If the sample size was larger, a doubling of symptoms would be significant.  Clearly more research is needed.  The FDA had asked Inamed to specifically study the health effects of rupture, but they didn't and neither did Mentor.

            The worst part of a ruptured implant is that so many women can't afford to have them removed.  I spoke to many women who were fighting with their insurance companies to have them pay for their explantation, and meanwhile, they got sicker and sicker, sometimes they lost their jobs, and, of course, then their health insurance. 

            So as you consider whether to recommend approval, think of the thousands of women who already have leaking silicone implants and don't even know it.  If you approve these implants, think of how many more women will be at risk.  Thank you.

            DR. GLICKSMAN:  Mr. Chairman and members of the panel, I'm Dr. Glicksman and I'm reading the testimony for my patient, Barbara Malony.  Barbara's a 63-year-old retired schoolteacher who could not leave because of her responsibilities for babysitting her grandchildren.

            As a young woman, my rather underdeveloped breasts were a constant source of embarrassment and disappoint.  Suits, blouses, dresses, what I wore made no difference.  I hated the way I looked.  Contributing to the misery were cruel comments and jokes about being flat-chested, from nasty teenagers in high school to thoughtless louts in adulthood.  After childbirth, the appearance of my small breasts worsened as they were not only flat, but sagging as well.  Though I thought it impossible for my self-esteem to be any lower, it plummeted.  Fortunately, I had the option of silicone breast implants and I chose it.  I did my homework regarding implants, the surgery, the plastic surgeons.  Be assured that this was neither a vain nor shallow decision.  I simply did not feel womanly.  My body was out of proportion and the periods of depression I endured due to my appearance, disrupting my life.

            After the surgery, the change in my self-esteem was more dramatic than I expected.  Clothes hung well on my now proportionate body, and my appearance was feminine and natural.  I didn't need to be perfect, just normal, and now I was.  As the years passed, the safety of silicone implants came into question.  I was worried about the illnesses that were being associated with them.  Also, what would I do when the time came to replace mine?  I read about saline filled implants and I knew women whose breasts were augmented with them.  I didn't like the look at all, but I would have no choice what went into my own body, until some very impressive studies completed in recent years found no link between silicone implants and the various illnesses in which they've been associated. "What a relief," I thought, believing silicone would soon become available again.  This, however, was not the case and as time went by, my aging silicone implants were hardening and becoming encapsulated. 

            Recently, I enrolled in a clinical study and had the original implants replaced with new silicone implants.  Why do tens of thousands of women have to wait so long to procure silicone implants?  They were shown to be safe in sweeping, reputable studies that breasts and psychological health are being compromised because with approval still withheld, women desiring implants or needing reimplantation surgery are given no choice if they opt for silicone.  There is only the far less appealing saline.  How can this be?  Many of us are paying with the denial with scarring.

            All women who consider breast augmentation deserve to have the option of silicone filled breast implants.  Of course, prospective recipients must be made aware of all the benefits and known risks, the complications of major surgery, and the necessity of implant replacement after time. We should not be denied the silicone, providing we are well-educated and can thus make our own informed decisions.  These implants are not the cause of major diseases with which they were linked, so says the U.S. National Academy of Science's Institute of Medicine, among many other prestigious organizations.  Therefore, the issue before you today ultimately boils down to having and making choices, which women are perfectly capable of doing. Thank you for your time and attention.

            CHAIRMAN CHOTI:  Yes.

            PARTICIPANT:  I'm reading the testimony of Aleina Tweed, an epidemiologist at the British Columbia CDC in Canada.  She was at the British Columbia Center of Excellence for Women's Health when she conducted research on breast implants.  She and I have no conflicts of interest, but she had a death in her family and was unable to be here herself.

            For decades, women with breast implants have reported high implant failure rates and unidentifiable illnesses.  In 1992, silicone gel-filled implants were restricted in the U.S. and Canada.  Breast implant surgery is not considered medically necessary and is, therefore, paid for privately in Canada.

            However, when there are negative health consequences of this surgery, Canadian women enter the public health care system for their care.  High complication rates have been well documented in the U.S., and our study finds relatively high complication rates for breast implants in Canada as well.

            We collected data from 147 women who had undergone breast implant surgery and compared their healthcare utilization to a non-implant comparison group, of 583 women of the same age and the same geographic location.  We also located implant related information from the study group, 92 return questionnaires.

            We found that women who had breast implants, number one, visited doctors and specialists significantly more often.  Number two: were more than four times as likely to be hospitalized.  Number three: experienced more hospitalizations.  So they were more likely to be hospitalized and had more hospitalizations over the study period compared to women without implants.  All these differences were significant when they statistically controlled for age, marital status, education level, exercise, use of alcohol, and geographic region.

            The study also found that half of the women who returned questionnaires reported at least one additional breast implant related surgery subsequent to the initial implants.  Of those, half had undergone one additional surgery; 23 percent had undergone two; 11 percent had undergone three; and 17 percent had undergone four or more additional surgeries.  For some of these women, the complications were enough to convince them that they no longer wanted breast implants, and 40 percent permanently removed their implants.

            Compared to most other studies, these women had their implants for a longer period of time.  Forty-two percent had their implants for 11 to 20 years.  Half of the women in this study had been diagnosed with at least one chronic illness, one in three had quit their job or reduced their work hours because of health problems, and more than half had problems doing housework or recreational activities.

            In summary, in Canada, breast implants appear to be -- appear to directly contribute to an increased need for public healthcare services.  The literature suggests there are many thousands of women in Canada and the U.S. who are using greater healthcare resources as a result of this surgery, and whose health and well being may be at risk.  After breast implants, many women report a cluster of symptoms, including those associated with autoimmune disease, connective tissue disease, or fibromyalgia.  The link between breast implants and systemic complications is still not clearly understood.  Epidemiologic research has not been conducted on large numbers of women who had implants for at least ten years, and that would be a reasonable period of time to determine the health risks.  And there have not been random samples of women with implants that have been accessible for such research.

            CHAIRMAN CHOTI:  If you could sum up for us, please.

            PARTICIPANT:  Sure; I have one sentence. Such methodologically sound, unbiased research is needed in order to ensure the safety of these devices and to allow women to make informed decisions about implant procedures.  Thank you very much.

            MS. LONG:  My name is Kacey Long, and I am here to talk to you today as an advocate for safer breast implants.  I have no conflict of interest, although I do owe my plastic surgeon $1,300.00.

            I myself received breast implants when I was 19 years old.  At that time, I was only aware of the good things that I'd been told that they would do for me.  I felt that I was out of proportion and they told me that that would make me in proportion. I felt like they were an easy surgical procedure and that I wouldn't need to do anything after I got them.  I thought I'd have them in forever and I thought I'd asked my doctor all of the important questions.  I was so wrong.

            My doctor never told me that my implants would need to be replaced every ten years, or even that I'd have to pay out of pocket each time something went wrong.  My doctor didn't tell me that there was no long-term data on how implants can affect the body or that there were women who'd gotten implants and reported physical problems that started only after they'd been implanted.  My doctor didn't tell me that my body would continue to grow into my early 20's and that because I didn't wait until I was older than 19, my implants could cause my breasts to be uncomfortably larger than what I'd wanted.  But most importantly of all, my doctor didn't tell me that it was possible I could have long-lasting physical effects from my breast implants.

            I stand before you today, a 22-year-old woman who feels decades older than she is.  I stand before you today, a 22-year-old woman who will never again be as healthy as she was three years ago.  But most importantly, I stand before you today concerned about the multitude of other women who are experiencing the same physical problems that I am, and our only common denominator is that we all received breast implants.

            It's easy to dismiss one or two women who complain about some physical ailments after they get their breast implants.  It's much harder to ignore it when you hear it from hundreds of them.  I receive e-mails every day from women all over the country who've had breast implants, and it's shocking to read how similar their stories are and how they write about their problems in the same way. I find it hard to believe that this is all coincidental.  As many doctors have told me that that's the way it is, especially since there's little to no data on how implants affect the body for the long run.

            How can you know it's all coincidence if you don't look into the possibility that it's not?  In the interest of women's health, in the interest of good medicine, and in the interest of not putting financial gain over providing solid medical devices, I ask you not to approve silicone gel breast implants until more studies can be done and more studies on women can be studied more closely.  Please take us seriously.  Please help keep us safe. Thank you for your time.

            CHAIRMAN CHOTI:  Are there any more speakers for the public session for this evening?  I think, then, what we'll do is we'll call the meeting for this evening adjourned, unless we -- well, I don't know if we expect anybody else later, but I think we'll adjourn for the evening and we'll see everybody promptly before eight o'clock tomorrow morning.

            Thank you all, by the way, for your time and effort for this public session.  It was extremely important to help us.  Thank you and goodnight.

            (Whereupon, at 9:34 p.m., the above-     entitled matter concluded.)