U

P-R-O-C-E-E-D-I-N-G-S

(6:35 p.m.)

EXECUTIVE SECRETARY KRAUSE: We're going to try to get this session moving so that the sooner we get started, I guess, the sooner we'll get done and we can all go home. So if everybody could grab a seat and all the speakers for the evening could make their way up front and introduce themselves to AnnMarie so that she can line you up, we'll all be happy, and we'll get -- we'll get the ball rolling.

We'd like to remind all the speakers to please make your financial disclosure -- state your name at the beginning of your presentation and make your financial disclosure. Also, we anticipate many speakers and we want to keep on schedule, so those lights -- there's lights on the second podium. When the yellow light comes on, that means you have 30 seconds left. When the red light comes on, that means you're time is up, whether it's three minutes or five minutes, depending on whether you're an individual speaker or representing an organization. And then once Dr. Choti asks you to please sum up, you have a few seconds before the microphone gets cut off. We hate to do that to anybody, but sometimes we wind up having to do that. So, please, make your statement, be concise, and we can get going. Okay?

AnnMarie, are you ready? Dr. Choti, please.

CHAIRMAN CHOTI: Please, welcome first speaker.

MR. HEYISON: Thank you. Good evening. I want to thank you for allowing me to testify tonight. My name is Marc Heyison, and I'm not being paid by any organization in exchange for my testimony.

In 1999, I co-founded Men Against Breast Cancer, the first national nonprofit designed to educate and empower men to be effective caregivers when breast cancer strikes a female loved one. My mom, who'll also be testifying this evening, is a 13-year breast cancer survivor and her courage is the inspiration behind the creation of Men Against Breast Cancer.

First, there are three topics I wanted to cover tonight. One is choice; two is interference with mammograms; and the third one is long-term safety. I wanted to start with choice because in considering silicone breast implants, choice seems to be the strongest argument for approval. I am strongly for choice for everyone, but a safe and informed choice.

Over the course of this meeting, I am sure you have heard and will hear from breast cancer survivors, healthy women, and/or plastic surgeons about the importance of choice in reconstruction between saline and silicone breast implants for augmentation. My question is: are aesthetics worth documented long-term health risks just to say you had a choice?

We're talking about the approval of a medical device requiring serious and risky surgeries, and will remain implanted in a woman's body until they fail, and 95 -- and 93 percent of those will fail within ten years, according to a "New York Times" article just this last week.

If approved, breast cancer survivors who have been battling traumatizing and damaging things, such as mastectomies, rounds of radiation and chemotherapy, will face additional complications and risks because of these devices. In fact, data reviewed by this very committee in 2003 show the reconstruction population experience far more complications and repeat surgeries, and nearly half the women had at least one additional surgery in the first few years. If approved, healthy young women are at risk of a lifetime of repeat surgeries, pain, and other complications. The standard for approval of this medical device should not be based on a level of perceived demand or allow a choice in breast implants. They should only be approved if they are proven safe for all women, which is not the case.

The second issue, to me, and quite compelling to the breast cancer community, is silicone breast implants obscure mammograms. Two recent studies, one in the "Journal of the American Medical Association" in January of 2004 and another conducted by the FDA's Office of Surveillance and Biometrics, also in 2004, clearly, clearly demonstrate breast implants result in missed and delayed diagnosis of cancer. According to the FDA's study, because silicone is radiodense, it has been shown to obscure between 22 to 83 percent of breast tissue.

While studies of this nature have not yet been able to definitely clarify difference in mortality, the FDA's study outlines research showing that there is, and I quote, "a difference in and possible limitation of treatment options." Women with breast implants more often had to undergo a total mastectomy instead of breast preserving procedures because of delayed diagnosis of cancer. According to the FDA, even under ideal conditions, alternative mammography techniques are limited and pose risks, and it still may be difficult to find cancer because the scar tissue develops around implants and can further obscure mammography.

The additional images necessary during screening may subject women with breast implants to at least double the radiation dose per mammogram than normal. The FDA's study also found that at least some portion of the breast implant population would stop having mammograms altogether because of severe pain and the fear of implant rupture during the mammogram. My mom is here today because of early detection, and it is widely medically accepted that the earlier breast cancer is detected, the greater the likelihood of successful treatment. Complications from mammography are a real risk and should be considered as heavily and seriously as other complications. This fact alone strongly argues against approval of these devices at this time.

There is life after breast cancer and that should be of the highest quality because the best care available was given and received. No one should have to look back and wonder if they made a choice for choice sake that could cost them their health and vitality.

My last area of concern, which was made clear from your 2003 panel meeting, are the many unknowns and concerns about the long-term safety of silicone breast implants, why the reconstruction population experiences significantly more complications and re-operations than the augmentation population. What are the long-term effects and complications of the real problems of silent or asymptomatic rupture, gel bleed, and silicone migration? If silent rupture and gel migration pose a risk, how is this risk addressed since the device does not fail in a manner that alerts women, such as with saline breast implants?

The only way women will have a true informed and safe choice is when we fully understand these devices, their failure and long-term, if not lifetime, risks. The goal should be approving a safe device, not labeling an unsafe one for choice sake. I sincerely hope the panel will address these concerns before a final vote against approval of these devices at this time. Thank you again for your time this evening. I appreciate it.

CHAIRMAN CHOTI: Thank you. Next speaker, please.

MS. HEYISON: Thank you. Good evening. I would like to thank you for allowing me to testify. My name is Gloria Heyison, and I'm a 13-year breast (sic) survivor.

In 1992, I was diagnosed with lobular carcinoma in situ. My world turned upside down. Despite the devastating diagnosis, I was fortunate to have two caring sons and a husband who held my hand every step of the way, from diagnosis to survival. My son, Marc Heyison, is also here to testify, founded Men Against Breast Cancer in 1999, to help men become more supportive partners when breast cancer strikes a loved one.

My story of survival starts at Johns Hopkins, where I had the best care available. Because of the nature of my breast cancer, I needed a radical mastectomy, and I was treated with Tamoxifen afterwards. At the time of my mastectomy, I was offered the option of breast implants. Based on the information provided, I seriously considered them as a reconstruction option, but a twist of fate prevented it. I had a terrible infection from my initial biopsy that meant I would have needed separate operations for the mastectomy and breast implants. I went home, discussed my options with my husband, and decided against reconstruction based on the fact that I would have needed an additional surgery.

At the time, deciding against breast cancer implants was a small sacrifice to avoid the added risk of one additional surgery. Little did I know that had I gone through with reconstruction with silicone breast implants, I would have been risking a lifetime of repeat surgeries and serious complications. Data reviewed in 2003 showed that nearly 50 percent of reconstruction patients required at least one additional surgery in the first three years. I was astounded to read in

the "New York Times" on April 7, that was my 48th anniversary, that the FDA estimates that 93 percent of women undergoing reconstructive surgery will have implant failure within ten years, and data reviewed in 2003 show that the reconstruction population also experienced four more complications than the augmentation population. Let me make an important point: additional surgery and serious complications are a high price to pay for breast cancer survivors who have already undergone treatment just to survive.

Based on the information I have learned, I stand before you this evening, relieved that I did not take the silicone breast implants and subject myself to a lifetime of pain, surgery, a risk of other complications, such as silent rupture and gel migration. Breast cancer survivors deserve a chance at a healthy life. Don't take that chance away by approving an unsafe device. Thank you for your time, and thank you again.

CHAIRMAN CHOTI: Thank you.

MS. BASCH: Hi. I am Lauralee Basch from Toledo, Ohio, and Inamed paid my expenses to come here. I want to thank you for what you do to protect us from products that can potentially harm us. Thank you for mandating that companies perform extensive research to make sure their products are safe. Thank you for listening to a group of women who seem to have health issues related to a product made to enhance their lives. This product being silicone implants. Thank you for doing your job in protecting me as a consumer. You have done a great job.

From the research you have done, you have found no direct link from the use of silicone implants to any disease process. No scientific evidence of harm. Countless women are subjected to a five-year study to help substantiate your scientific findings that silicone implants are safe, and the research continues, all with the same results: silicone implants cause no harm. Thank you for persistence in making sure I am safe. Now it is time to let go. It is time to let me choose what I put in my body. As not only a woman, but also a registered nurse, I deserve the right to make an informed choice of silicone or saline implants.

While saline implants are fine implants, they do have a tendency to ripple and wrinkle and are not as natural feeling and looking as silicone. Having had experienced breast augmentation firsthand, first with saline implants and then having had them replaced with silicone implants, I can attest to the fact that silicone implants are the more natural feeling and looking implant. It was the best choice for me and I should have been able to have had that choice initially.

Ironic that in your years of research, you determined that cigarette smoking was not only detrimental to my health but also to the health of those around me. You even warned me of this on the cigarette packages, and let you allow me to make that choice to smoke. Your years of research on silicone implants have not proven them harmful, nor have you been able to link them to any disease process, and yet I'm not allowed to make that choice. It is time to let go. It is time to let me choose and I choose silicone. Thank you.

CHAIRMAN CHOTI: Thank you. Next speaker, please.

MS. WALTON: My name is Bobbie Walton. I am reading testimony for Jean Winters, who was too sick to be here today. She has no conflicts of interest. I will read her words.

I have heard of the many stereotypes about women who get implants: stripper, go-go dancer, emotionally unstable, etcetera. Even if this stereotype were true, why should these women deserve less protection against defective devices than women with more respectable careers? What justifies a failure to conduct a long-term study of an implanted device before using it on hundreds of thousands of women?

My name is Jean Winters. I am an engineer and recently obtained a law degree. When I was a teenager, a doctor told me my breasts were deformed. I had tubular breasts and was already self-conscious about it. In my late 20s, I had surgery. The plastic surgeon insisted that the implants would correct my deformity. He said nothing about the side effects. He said the implants would last a lifetime. He assured me they would cause no problems.

I first became ill after I had a mammogram in 2000. At the time of my mammogram, my implants were 15 years old. The hospital was concerned that my implants might obscure cancer. There was no concern about rupturing the implants. This is understandable since the medical community refuses to acknowledge that ruptures create problems. I believe that was probably when my implants ruptured. I developed many symptoms, including rashes that never went away. One dermatologist just told me to stop scratching. Another suggested the problem may be systemic. I began to feel progressively worse. I had pain in my joints, numbness, extreme fatigue, and finally, vertigo.

After law school, I went to specialists, endocrinologists, rheumatologists, and neurologists. I was diagnosed with autoimmune thyroid disease, Hashimoto's thyroiditis, multiple sclerosis, and probable lupus. It never occurred to me that the problem might be my implants. When I was doing legal research for a retired physician, I told him about my health problems. He asked if I had breast implants. I considered the topic very private and was embarrassed. He said that my symptoms sounded like classic poisoning from silicone implants. At that moment, I could swear my heart stopped. He suggested I tell my doctor about my implants, which I hadn't because I believed the implants were of no consequence to my health problems.

My internist immediately ordered an MRI, which showed both implants were ruptured. I had them explanted. I improved, but I continued to experience pain and extreme fatigue. I worry about what my future holds. I am 50, not yet ready to retire or die. If I could turn back the clock, I would never have had implants. I hope and pray that I can recover from this, but I have no information on the long-term effects of silicone gel in the system. Doctors tell me they just don't know. This is outrageous, considering the length of time silicone implants have been on the market.

CHAIRMAN CHOTI: If you could please sum up. Thank you.

MS. WALTON: Why haven't long-term studies been done? Thank you.

CHAIRMAN CHOTI: Thank you.

PARTICIPANT: Hi. I'm reading on behalf of Dr. Laurie Young.

I am Dr. Laurie Young, Executive Director of the Older Women's League: The Voice of Midlife Women. I am a psychologist, and prior to coming to OWL, I was Senior Vice President of the National Mental Health Association. So today, I'd like to use my expertise from both perspectives and talk about the mental health benefits, or lack thereof, of breast implants for augmentation patients.

Over the years, we've heard a lot from implant manufacturers and plastic surgeons about the mental health benefits of breast augmentation. So an important question is: do breast implants have mental health benefits for augmentation patients? Patients say they want implants to improve their self-esteem and that it does improve their self-esteem, but no studies prove that claim.

Studies show that in the months following surgery, breast augmentation patients feel better about their breasts, but not about themselves. When augmentation patients are compared to other women of the same age, studies show that there are no differences in self-esteem, either before or after augmentation. Is that possible? Let's look at Inamed's own data, as presented at the last FDA Panel Meeting in October 2003. That data showed a decrease on every measure of quality of life, except feeling sexually attractive. Lower self-esteem, lower quality of interpersonal relationships. Feeling sexier or better about their breasts does not have the expected impact on women's lives in general.

This makes the studies about suicides and implants all the more important. Five studies have now shown that women with breast implants have a 300 to 400 percent increase in suicides. Researchers speculated that women who undergo augmentation may be more prone to suicide, but that is merely speculation and is not backed up by any well-designed studies, and suicide rates were four times as high when National Cancer Institute scientists compared augmentation patients to other plastic surgery patients, including women getting liposuction and tummy tucks.

It's important to note that another Dow funded study, which purported to show that breast implants were safe for women, in Denmark, actually found that women with implants were at least five times as likely to take antidepressants compared to women who do not undergo augmentation. They also found that women with more augmentation surgeries were more likely to take antidepressants, presumably because of the problems with the extra surgeries.

So, in summary, five studies show a 300 to 400 percent increase in suicides among women with implants. Four of these studies were of augmentation patients and one of reconstruction patients. Inamed's own data show a decrease in quality of life and self-esteem two years after getting implants. No studies show an increase in self-esteem two or more years after augmentation. One Dow funded study of Danish women found much higher use of antidepressants among augmentation patients, especially those with more than one augmentation surgery. Thank you.

DR. GLICKSMAN: Mr. Chairman and members of the Panel, my name is Dr. Caroline Glicksman, and I'm reading the testimony from my patient, Mary Elizabeth Dickerson, a 46-year-old mother of two, a single mother of two, with stage III breast carcinoma.

Because of my inability to attend, I'm requesting that my doctor read my testimony. My name is Mary Elizabeth Dickerson. I'm 46 years old. In December of 1994, I was diagnosed with breast cancer and underwent a full mastectomy with reconstruction. Through a series of surgeries and thanks to a tissue expander, I was able to have my breasts reconstructed with a saline implant. I had that saline implant for seven years. My breasts certainly weren't identical and the saline implant wasn't all that comfortable. It felt like a tennis ball in my chest. It was uncomfortable to sleep on my stomach, and because of the shape of it, it pulled on my clothes, so the buttons of my blouses pulled to the right. Of course, these little things not being bothered with when, in the grand scheme of things, I had my health.

In 2001, my doctor started to speak to me about switching to a silicone implant and being part of a study of women with silicone implants. My doctor was participating in the study and she gave me a lot of material to read and research before making my decision. I had been with my doctor for seven years at that point and trusted her completely. I made the decision to have the new implant put in and did so in December of 2001. The silicone implant is ultimately more comfortable, more symmetrical, and feels the same as my natural breasts. I have had this implant for over three years and have had no problems with it. In fact, in December of 2004, I was again in the hospital for surgery for a recurrence of breast cancer. For the surgery, my doctor, working with a thoracic surgeon, reopened the old incision, removed the implant, and after removing as much of the tumor as possible, replaced the silicone implant in my chest.

In closing, I just wanted the committee to know the silicone implant is much more comfortable than the saline implant. I am very satisfied with it. Hopefully, the work of my doctor and the other doctors are doing to get silicone approved by the FDA will help other women to be more comfortable in their own bodies. Thank you. Mary Elizabeth Dickerson.

MS. VEVEZ: My name is Olga Vevez, and I'm reading for Judy Kemecsei, who could not be here today. We have no conflict of interest.

My name is Judy Kemecsei. I have no conflicts of interest. When I got silicone implants, I was never told about any of the risks. My doctor assured me they were safe. I went to a doctor a few years ago and told her that I had no problems with my implants, but had read that they all eventually leak. I asked, "Wouldn't it be better to take them out now?" She said they looked great and were not ruptured. I left them in. I had no health problems for 20 years, but then started to feel pain in my chest and have difficulty breathing. I have numbness and pain down my arms. I was always very fatigued; just going to work was difficult. I called surgeons to get my implants taken out. I thought the symptoms might be related to my implants. I spent a lot of money going from one plastic surgeon to another, and each told me that my symptoms were unrelated to my implants.

I had a number of mammograms. None of them showing that my implants were ruptured. I was told that an MRI would be better at detecting rupture, but I could not afford the additional cost. I made the decision just to have the implants removed and finally found a plastic surgeon who agreed to remove them without replacing them. He said when he opened me up, my implants were totally ruptured. It was a mess. The silicone gel went up to my clavicle and into my armpit areas. That was why I had the pain in my chest. It is very hard for me to believe that most of the plastic surgeons don't know that the classic symptoms I had were caused by implants. The doctor got out what he could. Unfortunately, it can't be all mopped up since it's like glue.

This has changed my whole life. I had never been sick, but now I'm in pain every day of my life. My breasts are very sore. Who knows if they will ever feel the same again? I was cut open and scraped, not to mention that the top of my breasts are indented now and my breasts will never look normal again.

My implants lasted a long time, but like most women in the FDA study of the implant rupture, they eventually broke. Even the implant maker's own data show that the implants break and women don't realize it. If plastic surgeons had told me that implants don't last, I would never have gotten implants. Plastic surgeons replace leaking and ruptured implants every day, and put in new ones, like changing tires on a car.

I was so happy when the FDA rejected Inamed's application at the end of 2003 and demanded long-term safety data. If I had been studied for only four years after getting implants, like the industry suggests, they would have found nothing wrong with me. I was thrilled the FDA put the safety of patients first. Why, we ask you? Why are we -- you back here today, barely a year later, considering it again when there's still no long-term safety data?

More and more women are getting implants, especially young women, which makes your responsibility even greater. Women across the country are counting on you to protect us. Thank you very much.

CHAIRMAN CHOTI: Thank you.

DR. GLICKSMAN: Mr. Chairman and members of the panel, I'm Dr. Glicksman, and I'm reading the testimony for my patient Katherine, a 19-year-old college student.

At the age of 16, I noticed one breast was not growing like the other; one being completely flat, not even a AA bra size, while the other was growing normally, already a full B. For an adolescent, this defect came as highly uncomfortable, embarrassing, and even restricting on a daily basis. For example, embarrassment of changing in public areas, in gym class, for example, and school, being unable to wear loose or open clothing, and the tortures of putting on a simple bathing suit or going bra shopping. My new constant alert and sensitivity to this bodily issue was very disheartening until I found hope a year and a half later with my physician.

I was told my case was pretty rare, definitely abnormal, and at my age, would not resolve itself with much more growth in the future. Thus, I was recommended plastic surgery and through a personal referral, found my doctor, my plastic surgeon. Shocked, at first, that plastic surgery was the way out, I started to learn for the first time about breast implants and much differently from the way phony TV shows portrayed them. My doctor covered everything with me, excluding nothing: the initial history of implants around the world, cost differences between silicone and saline implants, sizes, the importance of finding a certified plastic surgeon, past and present concerns and debates over these products, the risks involved then and now, and the choices and options I had, along with their advantages, benefits, and disadvantages. Then, if I had any further questions or doubts, these were addressed as well. She recommended a foam implant sold in clothing stores to wear with bathing suits to temporarily hide the physical difference and calm my constant fear of being noticed, while I waited six months in case of any change in development and turned 18.

On my second visit in mid February, I returned, ready to make a decision about surgery. I was given proper, clear instructions on how to prepare for surgery, as well as reminded how the recovery process would go. Three weeks later, I underwent my first surgery ever, a unilateral breast augmentation surgery, done by my doctor herself in a private hospital facility. I was prepared and the only fear I had was of inexperience with surgery in general. After my -- my doctor came in and asked me one last time if I still had the desire to undergo surgery and filled out the remaining necessary paperwork with the nurses and proceeded into the surgery room. The recovery was definitely not a quick fix deal, including much physical discomfort to fulfill the needed healing while -- but with the help of my doctor's orders on how better to recuperate, it was worth it. Nothing compared with the pain I felt for years inside about myself, when I knew of no alternative, and before I had the opportunity to make a choice that changed my life.

This is what silicone implants have done for me. While freedom is a word this country prides itself on daily, I was given freedom to feel just like everybody else, through this surgery, this product, and this deserved choice.

MS. JACOBS: May I begin?

CHAIRMAN CHOTI: Yes, please, go ahead.

MS. JACOBS: I'm Marti Jacobs from Arizona. I have no conflicts of interest.

I got silicone gel implants because of severe breast atrophy. I never wanted larger breasts and I never would've gotten them had I known it would destroy my life, my career, and my health, (slide one). I was healthy, yet nine years later, I became very ill. Tomorrow, industry will present only four years of data. Had I been in those studies, none of my problems would've shown up. Surely, we need long-term studies. After nine years, numerous symptoms presented, such as, (slide two), significant hair loss, as well as abnormal white blood cell count, fatigue, rashes, etcetera. These symptoms coincided with my right breast shifting lower than my left. It did not occur to me that it was anything but a slight change in breast tissue. Now I believe this is when my right implant ruptured.

My medical records document lupus, Sjogren's, fibromyalgia, and chronic fatigue, all common conditions for many women with implants. I had to go on Social Security Disability. The Social Security Administration determined my date of onset of my silicone-related illness was nine years post implantation. Twenty years after implantation, a mammogram report concluded there were no ruptures. Just months later, I had my implants removed, only to find both were, in fact, ruptured. According to my operative report, "On the right side, there was total disruption of the implant and no visible shell was seen. On the left side, there were also several gross ruptures of the implant. It was obvious that the implants had been ruptured on both sides for quite some time."

Upon removal, my neurological problems have somewhat improved, but I still suffer with debilitating chronic fatigue and much more. Perhaps there is still silicone in my body. As you will hear from company data, most women do not even realize when their implants break and mammograms are not reliable to tell them. MRIs have been proven to be more reliable, but how will women afford them? How would women get an MRI immediately upon a rupture? How will women afford and receive the urgent removal surgery they would need? That is why so many women have been exposed to leaking silicone. What possible reason can these companies have for never providing you with long-term safety data, especially when women like me have expressed our concerns, over and over again?

I question whether silicone gel implants can ever be proven safe, and ask you is it against the -- if it's against the law to inject silicone gel into women's breasts, what on earth makes it okay to put it in a breakable baggie? Since we know implants break down and rupture, wouldn't it have to be proven safe for gel to be inserted directly in breast tissue? That's what a rupture is. If you approve these implants, you will not be protecting women because they will believe they are safe, when, clearly, this has not been proven. Please just say no, and I have more pictures on a handout on a table outside. Thank you very much.

MS. WALKER: My name is Carol Walker and I am reading the testimony of Jennifer Pythian, who didn't have enough money to come to be here today. Neither of us have any conflicts of interest.

My name is Jennifer Pythian and I live in Denver, Colorado. I was 18 years old in 1986 when I received my silicone breast implants. I didn't start experiencing any health problems until approximately five years after getting implants. I was increasingly fatigued, experiencing burning sensations around my breasts, and suffering from joint pain.

My plastic surgeon at the time was my employer, and he told me that my problems were nothing to worry about. He said that if it was truly a concern for me, he would replace them with saline implants. I could not afford the replacement at the time, and although this was the same surgeon who had inserted my silicone implants for me at no cost, he was not willing to replace them for free. I believe that if my plastic surgeon had any sense of ethical responsibility, he would've taken the silicone gel implants out for free since he had put them in, but, unfortunately, that did not happen.

Because of lack of money, I was forced to leave the silicone implants in. I had three children while my implants were inserted and was unable to breastfeed any of them because the implants prevented my body from producing enough milk to keep them healthy. Prior to implants, I was a very healthy woman. I had never had any serious health problems. However, afterwards, I suffered from an array of illnesses that have caused me chronic pain, chronic fatigue, and a daily feeling of unexplainable, overall ill health.

I had my implants removed last December and I began to feel better immediately. My health improved dramatically, almost instantly. I no longer feel fatigued, no more burning sensations, and no more achy joints. Every one I know has commented on how great I look. Some have even said they have not seen me look so healthy in a very long time. I can even tell a difference when I look in the mirror every day, and I am so thrilled about how much younger I look and feel.

At the time I was given my silicone implants, I was not aware of any risks and I was not warned of any either. Maybe if they did warn me of any risks associated with silicone implants, I wouldn't have had them put in. Taking out my implants is the best thing I could have done and wish that I could have had it done sooner. I can only hope that my experience and testimony will help other women. I wish I would have known then what I know now. I don't think you can force plastic surgeons to give informed consent. My plastic surgeon was my employer, but he did not tell me what I needed to know. I don't think he would've performed free surgery on me if he thought it would harm me. That's why I question whether there is any way women can truly learn about the risks before getting implants.

CHAIRMAN CHOTI: I'm sorry; if you could sum up, please, for us, we'd appreciate it.

MS. WALKER: All right. Instead of learning the hard way, as I did.

CHAIRMAN CHOTI: Thank you.

MS. GREEN: Good afternoon. My name is Minnedore Green and I'm reading the testimony for Karen Curry. She nor I have conflicts of interest.

In 1983, I went -- underwent a preventative bilateral mastectomy. I didn't consider reconstruction right away. I had a difficult time dealing with the loss of my breasts, which, to me, encompass my femininity and my beauty, but enduring another surgery was far from the top of my list. Two years later, I consulted with a plastic surgeon and was assured that reconstruction with breast implants was safe. The surgeon showed me photos of patients and said that there were no complications to worry about. Reassured by his confidence in the procedure as a product, I was reconstructed with silicone gel breast implants when I was 36 years old.

Just one year later, I learned that there were, in fact, complications to worry about. My implants began to harden and began -- became extremely painful. I began to experience serious health problems. In 1990 -- in 1988, I was diagnosed with benign multiple sclerosis and a number of other conditions. I have always been an extremely active and healthy person. I have always had the energy to be active with my three children and work full-time, but slowly, my health deteriorated. My husband took care of me when I could not take care of myself. I was unable to do the things that I love to do.

In 1997, a mammogram indicate