Jane Thompson, Ohio

I have no financial relationship with any group or company that may be affected by silicone breast implants.

After 16 years with my textured McGhan saline breast implants, I switched to Allergan’s new cohesive silicone gel breast implants last July. Almost immediately I began to feel quite ill. I had extreme fatigue, numbness and tingling, nausea, dizziness, heart palpitations, hair loss, depression, severe insomnia, ringing ears, weakness, stomach/headaches and anxiety.

Then around 3 months after getting the implants, other major symptoms appeared: chest pain, uncontrollable tremors, vertigo, widespread severe muscle/joint pain, symptoms similar to multiple sclerosis, difficultly swallowing, drooling, liver pain, loss of peripheral vision, symptoms of interstitial cystitis, severe skin tightness, face pain/lock jaw, vomiting, diarrhea, and dry throat/eyes. I was diagnosed with lymphadenopathy. I developed several ovarian cysts, stopped menses during this time, had tongue swelling, facial swelling, difficulty breathing, low white cell count, memory lapses and suicidal thoughts. I lost 20 lbs in 3 weeks. I became completely dependent on family and friends.

These were symptoms I had never had before, all of which developed in the short time I had Allergan cohesive gel breast implants. Prior to receiving these cohesive gel implants I had only seen my doctor twice a year for a refill of thyroid medication or the occasional minor illness or cold.

I had my implants surgically removed after 5 months, in December of 2010, and immediately the symptoms started to disappear. Ninety percent were gone immediately and the remainder of the symptoms disappeared over the next few weeks.

There are no words to fully describe the horrific experience these new cohesive gel implants caused me and my family. I received no warning about the possibility of the gels triggering my immune system and causing life-changing disease. I saw a total of five doctors during this time with my gel implants and they all believe the implants stimulated my immune system. Not one of those doctors doubts that I had a very strong immediate reaction to silicone gel.

My terrible autoimmune reaction was reported to Allergan, but in their records they falsely stated that my autoimmune symptoms occurred before my implants, not after. Their report states: “There is no complaint against the devices. The patient has a history of multiple medical concerns prior to implantation.” That is completely untrue. Prior to my gel implants I had a minor thyroid problem that was under control. After getting cohesive gel implants, I had very serious autoimmune symptoms that were completely devastating.

It wasn’t until after my gel implants were removed that I learned that Allergan excluded from their breast implant study any women with any kind of history of autoimmune symptoms, either personal history or family history. That information is not widely available, but is listed as a “precaution” on page 12 of the Allergan patient booklet, which states that safety has not been established for women with autoimmune diseases. This booklet is considered labeling that the FDA supposedly requires plastic surgeons to give to patients, but I never received a copy.

There should be a very obvious warning for women with any kind of personal or family history of autoimmune symptoms or diseases, with a black box around it. Instead, the FDA included the above vaguely worded precaution, which did not explain that women with autoimmune issues were intentionally excluded from studies because of concerns about how their health could be harmed. Since the FDA didn’t require that information, neither the companies nor the plastic surgeons are warning patients. And, earlier this summer, the FDA went on record as saying that there is no proven link to autoimmune diseases, without even mentioning that the implant companies excluded women with autoimmune symptoms or history from their breast implant studies. This is an outrageous situation. I was terribly harmed by my implants. A black box warning would have persuaded my doctor that I was at risk of health problems from breast implants because of my thyroid condition.

I was lucky that the link to my implants was so obvious, but what about the women who have mild or even moderate reactions? It might not be obvious to them or their doctors. Or, even for women who have an obvious reaction, remember that some of those women won’t be able to afford to have surgery to have their implants removed. You can get implants put in on an installment plan, but if you want them removed you need to pay before the surgery.

There need to be clear warnings about the dangers of silicone gel implants, so women can make an informed decision on whether or not to take that risk. And the research that you require on implants needs to focus on the kinds of autoimmune symptoms that women with implants are reporting.

Jane’s story was read at the FDA Advisory Committee Meeting on breast implants in August 2011.

Oregon

In September 2007, I had a double mastectomy. I had been scheduled to have my thyroid removed at the time I found my lump, but that was obviously postponed. About six months later, my plastic surgeon recommended silicone breast implants. I was interested in having a flap surgery using my own tissue but since there wasn’t any surgeon versed in doing a free-flap in my area (in my state at that time), I wasn’t opposed to having implants since I was assured they were safe. My plastic surgeon advised me that if there were any problems it would be easier to remove the implants and have flap surgery than it would be to correct a problem with flap surgery.

Three months after I got my silicone implants, I started to feel horrible. I was terribly tired and achy, making it difficult for me to move. My husband commented that I seemed like an old woman, though I was only 48. Something was obviously very wrong, but I had no idea what. I had no reason to expect that the implants were the cause of my symptoms. I looked into a number of possible causes including bone cancer, the tamoxifin I was taking, my thyroid replacement, depression, or rheumatic disease. When nothing I or my physicians tried worked, I began to suspect the implants.

I decided to have my implants removed and my breasts reconstructed using the DIEP flap surgery. Initially, my health insurance provider agreed to cover the DIEP surgery, but I was surprised when despite my surgeon’s and my doctor’s approval of my choice, my provider changed its mind and decided not to cover DIEP reconstruction after all. The provider argued that it had already paid for breast reconstruction once and that there was no proof that it was my implants making me feel so terrible. I told them that the way I felt with silicone breast implants was worse than when I was on chemotherapy, and finally after going back and forth with them for almost a year while I was in poor health, they agreed to pay for DIEP reconstruction if I could prove that the implants were causing my pain. If I had the implants removed and my symptoms stopped, they would consider this proof and cover the DIEP surgery.

I had my silicone breast implants removed in August 2010. Exactly one week after they were removed, I woke up and felt like my old self again. This past January, I had a successful DIEP reconstruction. This is definitely a difficult surgery, but I feel better than I have in about 3 years.

I was never told that women with thyroid problems could have an autoimmune disease that makes them more vulnerable to health problems if they get breast implants. It was only when I was preparing my statement that I learned that the patient booklet required by the FDA says that the safety of breast implants has not been established for women with autoimmune diseases. I might have been given the booklet at the time I was fighting my breast cancer, but this was an extremely difficult time and I was researching and reading a lot of material. One small statement in all that material would not have had a significant impact.

I wish I was there to ask you to make sure that research is done to determine if breast implants are more risky for women with thyroid conditions or other autoimmune symptoms or conditions. It seems that FDA requirements are getting ignored by the implant companies and I don’t believe plastic surgeons want to believe that implants may be causing women health issues.

Meanwhile, the FDA needs a better warning than the one sentence on page 12 of a patient booklet that most patients never see. Additionally, I wish you were also the insurance commission, because no one should have had to fight their insurance for their health!

Judy’s story was read at the FDA Advisory Committee Meeting on breast implants in August 2011.

Ohio

I was 38 years old in 2008 when I decided to get Mentor MemoryGel breast implants. Prior to receiving my implants I was the Vice President and Operator of a successful $3 million Special Events company. I was in very good health, only some typical allergies. I worked out at the gym 3-5 weekly, was very social in my community and traveled frequently.

I no longer have my fabulous job; I now work in the sales department trying to make ends meet. I struggle to work 20-25 hours a week but desperately try so I can keep my health insurance, home and livelihood.

I am in the Mentor study that you will be discussing at this meeting. I want to explain to you why the study is not going to provide information about the terrible health problems that I had from my implants.

I am 5′ 10″ and have always been quite thin. I have been a size 2-4 since high school. I wanted to have some “curves” and thought breast implants were the best solution. I interviewed three doctors, got a reference from another patient, had a baseline mammogram, and passed my physical with flying colors. All three doctors told me the MemoryGel implants don’t leak and showed me a photo of the implant cut in half. Looking back, I wasn’t really informed about saline or other implant choices. The doctors didn’t discuss the possible health complications.

I had surgery in April 2008. I returned to work within five days, but I had complications right out of the gate. I had intense burning on my right breast that turned fire red and my sternum swelled and bruised so bad I had to wear an ace wrap for an additional 10 days. After two months, I began getting one symptom after another. During the first year the symptoms included chronic canker sores in my mouth, my hair falling out, my chest turned a deep red color and would burn when I was exposed to sunlight, I became irritable and moody, and scents were overpowering to me. I started to have insomnia and sleep disturbances, I gained weight (15 lbs in 4 months) for the first time in my life, had regular headaches, fatigue, and loss of libido. I would catch colds and flu frequently and couldn’t shake them. My surgery incisions never healed properly. I went to my implant doctor for my one year follow-up and by then I had lost about one-fourth of my hair. He said “there is no way your hair loss is related to your implants.” I believed him, felt intimidated to even ask about my other symptoms being related to, and didn’t second guess the implants for another year and a half.

The following year, things got worse. I was having brain fog and dizzy spells frequently. My right thigh started having a burning sensation going through it about twice a week. My sleeping issues got worse. At this point I had to cut back my hours at work. My muscles would get tired and achy easily, almost a weak feeling. By the end of my second year I had pretty much stopped going to the gym because I was exhausted.

My last year with implants was a living hell. I lost my boyfriend of 4 years, my position at work, friends and my volunteer work. No one understood my health issues. I am single and own a home and have financial obligations. I lost much of my income due to illness. I went from being active and productive to feeling ill and not being able to get out of bed.

In November of 2010, I hit rock bottom. My fatigue was so overwhelming I couldn’t go to a grocery store. I was having stomach issues on a regular basis, waking up in the middle of the night with migraines, I couldn’t cope with light and sound at the same time, I couldn’t comprehend literature or even emails or memos, my legs and arms became chronically weak and in pain every minute of every day, I had tinnitus, I would forget very basic tasks and recollections, I had terrible joint pain in my wrists and ankles, fatigue, heart palpitations, 1/3 of my hair was gone and my eyes were blood shot and in pain as well.

I had to get help. My Primary Care doctor wasn’t sure what was causing this after running blood work, sending me to get a CT scan and visiting an endocrinologist. In the back of my head I always questioned my implants.

I asked my endocrinologist what he thought about the implants and he said “the only way to know is to get them taken out.” I believe his words saved my life.

On December 28, 2010 I had my implants removed. My ex boyfriend came to help me with the post surgery care. My pathology report came back stating that I had “microcysts that contain refractive unstained material, consistent with silicone” in my left breast tissue. So, the implants that wouldn’t leak did, even though they were not broken.

Since surgery I have been trying to regain my health. Many of my symptoms have improved. I no longer have issues driving, my fatigue is still here but better, my stomach issues are gone, migraines are seldom, my hair isn’t falling out in clumps, my tinnitus is gone, and I am much calmer.

If my implant doctor would have even said my hair loss POSSIBLY could be from my implants, I would have had them removed after year one. Instead I went around for an additional year and a half getting much sicker and now wonder if I will ever completely recover.

People trust their doctors to give them complete and accurate information. I don’t feel I received this regarding my breast implants. I haven’t heard from him or his office since my one year check up. It took a month for me to get my medical records released from his office for my explant surgery. I have contacted Mentor a couple of times and they give me my patient “number” and a voicemail.

I do fill out my Mentor post-market surveys annually and tried to fill out the “Interim Complications Survey” but it is just that, a survey that asks me questions. It doesn’t ask the right questions to be able to describe what happened to me. It does not ask about most issues or complications that I am having. It asks for a specific diagnosis. The doctors have not given me a diagnosis. All I have is a list of many horrible symptoms.

After over $25,000 in surgery costs and medical bills and over $50,000 in lost wages, I am still trying to recover.

I am sorry I can’t be at the meeting to tell you this in person. I am wondering whether those of you on the panel who voted to approve silicone breast implants 5 years ago will be willing to admit that there are many patients like me who are being harmed by their implants.

I hope all of you will agree that the research that has been done so far is not asking the right questions about the symptoms that so many of us are experiencing. If you can make sure the right studies are done, and make sure that doctors and patients across the country are aware of the risks of breast implants, I hope you can prevent other women from going through the hell I have gone through.

Chelsea’s story was read at the FDA Advisory Committee Meeting on breast implants in August 2011.

Tennessee

I am Susan Helman from Gatlinburg, Tennessee.

I am here to address the question of post-market long-term safety studies and issues resulting from silicone gel breast implants.

I wrote a book, now in second edition, which included interviews with more than 50 women and was based on information from more than 250 women –all different, yet all suffering with similar illnesses, just different levels of disease directly related to the silicone gel in breast implants.

The eventual rupture of the implant allows this gel to travel throughout the entire body, including crossing the blood/brain barrier. Once the silicone gel has spread throughout the body there is NO way to remove it!

The long-term exposure to the chemicals and microscopic platinum and heavy metals in silicone gel implants causes debilitating, acute and chronic symptoms, similar but not identical to some of the symptoms of diseases such as: multiple sclerosis, lupus, chronic fatigue syndrome, fibromyalgia, rare lymphomas, multiple neuropathies, and multiple chemical sensitivities. In fact, research has clearly shown an increase of giant macrophages after breast implants are in the body,

Long-term research is important here because I was not diagnosed with Reynaud’s disease or Sjogren’s until over 11 years after implantation. My diagnoses stand as silicone gel induced disease processes and silicosis.

We, the women who have been “guinea pigs” for plastic surgeons and manufacturers, have never had the opportunity for informed consent because of the lack of objective, long-term scientific data.

When women with implants tell their doctors about their health problems they are treated as hypochondriacs! We have been told by most doctors our health problems could not possibly be caused by our implants. Yet, many of us do get better when the implants are removed.

Silicone gel breast implants provide a very comfortable income for plastic surgeons and manufacturers F D A requires the implant manufacturers to conduct long-term research, but there are 2 major problems with the research:

1. F D A did not do a good job of making sure the studies were well designed, so that even those that are completed lack some of the most important information about health effects. The F D A did not seem to care that the manufacturers did NOT want to measure the increase of autoimmune symptoms. Instead of evaluating the symptoms that are most strongly associated with silicone gel implants, F D A allowed the companies to focus on the diagnoses of connective tissue diseases, most of which are rare. These kinds of diseases are diagnosed after years of symptoms, so that 10 year studies are not long enough.

2. In most of the studies, the companies lost track of the patients early on. What happened to women whose implants were removed? It seems that in most cases the women were removed from the studies, so that the very women whose problems were most severe are NOT included in the studies! The manufacturers and the plastic surgeons helping with the studies were happy to focus on the women who had no problems with their implants.

This has biased the results!

My implants ruptured and have been removed. However, I still have platinum and silicone that has crystallized in my saliva, my mucous, urine, and blood. My eyes, ears and nose also ooze crystallized platinum and silicone. As a direct result from the chemicals and heavy metals used to manufacture silicone gel breast implants, I suffer daily with the symptoms of M.S, lupus, visual problems, fibromyalgia, multiple chemical sensitivities, severe migraines, peripheral neuropathies, and demyelinating lesions on my brain!

The remaining capsules, tissue, lymph nodes, 3 bone marrow samples and foreign materials found upon subsequent surgeries over eleven years after implantation, were sent to the pathology lab of Dr Hardt at the University of Florida Department of Pathology, as well as a Forensic Toxicology Lab in Houston. These samples were found to have extremely high levels of the identical silicone, polymers, platinum and foams found in the silicone gel in my implants. These levels of residual silicone gel in my body are most definitely causing my illnesses. I have been told that I cannot donate my organs as they all contain silicone and polymers.

I hope the panel will make sure future studies of breast implants include the most important questions regarding health risks, and are conducted appropriately. The implant makers should pay for the studies, but they should NOT design the questionnaires or analyze them. The companies now have a track record of poor study design and implementation. It is time to have independent researchers take over those studies – designing them, running them, and analyzing and interpreting the data.

Thank you.

Tennessee

Hello – my name is Pete Dorsey, I am the husband of Susan Dorsey and we live in Mt. Juliet, Tennesee, which is a suburb of Nashville. I am here in support of my wife who was a participant a while back in a clinical research trial of silicone breast implants offered by Vanderbilt University Medical Center in Nashville.

Susan and I have been together since 1999 and, until she became a participant in the silicone breast implant study, she was extremely healthy, physically active, very confident and a lot of fun to be around. In 2005, almost immediately after she had her existing saline breast implants replaced with silicone implants, her health, her life and my life began to change. Not only would Susan describe to me the unusual things that she was feeling, but I could definitely notice some of the changes taking place in her. She started complaining of things like dizziness, various joint pains, physical and mental anxieties, blurred vision and a host of other symptoms that were all new and that we did not understand the origin of at the time.

With these things happening to her, our lives changed. As things became worse, she became almost reclusive, and our social lives became very limited. All kinds of doctor and medical visits became a necessary part of our lives. As the months went by, her health got noticeably worse. She reached the point that she couldn’t even drive herself. I therefore had to somehow work into my job schedule the various trips she needed to make to her medical appointments.

In the years we spent together prior to her 2005 silicone implant replacement surgery, Susan was always very much in-tune with her own body and the health of everyone in our family. She began to question her overall health and became suspicious of her new implants. Although unsure of exactly what was causing her new multiple health issues, she made the wise choice to have the new silicone breast implants removed from her body.

After removing these silicone implants and having them replaced with saline ones, her health immediately began to change for the good. Many of her symptoms and ailments started to disappear and today -six years later – her good health has almost returned.

I am here today as a concerned husband to tell you as best that I can, in the time I have been allotted, that my wife has needlessly suffered due to the silicone breast implants that were sold to her and surgically put into her body. As a family, we were forced to endure many trials and tribulations that should not have ever been. Not only can I advise you of the adverse changes that took place in my wife, Susan, and in our lives as husband and wife, but I can certainly also quantify the $100,000 plus that we have had to spend because of this mess. In my opinion, these particular silicone implants should be totally banned from use and not be allowed to ruin anyone’s life ever again.

Pete testified at the FDA Advisory Committee Meeting on breast implants on August 30, 2011.

Tennessee

My name is Susan Dorsey, I live in Mount Juliet, TN and I am here to share with you my experience as a participant of Allergan’s Adjunct trial for silicone breast implants.

I have always been very healthy and physically active. When I turned 40, in 1995, I had saline breast implant surgery. I enjoyed those implants for ten years. Then, in 2005, I decided to have them replaced for cosmetic reasons. I met with Dr. Kenneth Hagan, at Vanderbilt, who recommended that I enroll in the silicone implant trial there. I paid my $6,000 and enrolled.

Recovery for this breast surgery was much the same as my saline surgery in 1995. However, about a month post-surgery while getting ready for a Christmas party, I remember having difficulty raising my arms over my head. Later in December, my family spent the holidays in the Caribbean. While there, I experienced flu-like symptoms and spent most of the time in my room believing that I had swallowed some of the water or eaten a food that wasn’t agreeing with me.

January brought more new symptoms. The neck and shoulder pain that I had felt in December had worsened to the point that I was going to physical therapy three times a week. My vision had become blurred and I was experiencing loud buzzing in my ears. Every day seemed to bring new health issues. These included: severe joint pain, dizziness, anxiety, tingling hands/feet, heart palpitations, insomnia, depth perception problems, loss of appetite, metallic taste in my mouth and others.

Over the course of the next nine months, I had 24 doctor’s appointments, including neurologists, orthopedic surgeons, and others. I also had 31 physical therapy appointments, 2 MRI’s, 2 spinal epidural procedures and an admission to Vanderbilt’s emergency room. In all, there were 63 medical appointments in the nine months following my joining the research trial. Six months into the study, I felt close to death and called my daughter who was in college in Kentucky. I asked her to take care of my 12-year-old son if anything happened to me. I prepared my will, expecting I would not wake up one morning. During the year before getting silicone implants, I had only routine doctor appointments limited to annual physicals and a stomach bug.

Ten months into the study, I met with Dr. Hagan and advised him about the deterioration of my health since being in the study. I asked to have the silicone implants removed and replaced with the saline implants I had prior to the study. I was advised that there was no exit strategy from the study and that the implant removal would be done only if I had the money to pay for their removal. He added that for my trouble, he would throw in a free breast lift and that he would contact Allergan to see if they would provide the saline implants cost-free. They would not. I paid the $3,500 and was dropped from study on September 29, 2006 when my silicone implants were removed and replaced with saline implants. During the time I was enrolled in the study, I had no contact from Vanderbilt or Allergan. I called Allergan and left a phone message stating I had some health problems due to the silicone research trial and requested a return call. I followed that with an email. I received no return call and the email response from Allergan read: Thank you for your inquiry. We are a leading manufacturer of plastic surgery products and we are happy to provide you with information that may assist in answering your questions. Your inquiry has been received and will be responded to in a timely manner. Due to FDA regulations that apply to manufacturers of plastic surgery products, we cannot comment on any particular medical condition, surgery or physician opinion.

On April 16, 2007, seven months after the silicone implants were removed from my body, I sent Allergan a certified letter advising that my medical problems were subsiding and that Vanderbilt’s Dr. Hagan told me that the study implants were returned to them for testing. I attached a copy of the Device Identification Forms requesting the test results be mailed to me. I heard nothing back.

I believe that most of this horrific period in my life could have been avoided had I been monitored during the time following my enrollment in the study. Not only was there no follow-up, but matters were made much worse when my requests for help were ignored. It was clear that no one was interested in hearing about my adverse reactions. Vanderbilt’s Dr. Hagan wrote in my chart that my newly-diagnosed fibromyalgia was most likely a coincidence. What kind of research is that?

During my participation in this pseudo-research trial, I had over $100,000 in medical expenses, along with suffering lost wages of over $400,000. Fortunately, I had the mental and physical strength and the financial resources to get through the past six years. I know of several other women who were not as fortunate. I wonder if the kind of research conducted by Allergan would have identified or evaluated the kinds of serious health reactions I had to the silicone implants. I was forced out of the study when I made to decision to remove the silicone implants in order save my life. All records about my medical problems were deleted as though I never existed. Despite my repeated efforts, Allergan was not interested in learning about how their silicone implants harmed me, or how my health improved when they were removed.

At the very least, the FDA must make sure that safety studies by implant companies should be conducted in an ethical manner. Problems should be reported and injured participants should receive appropriate medical care. It is your job to make sure this situation changes immediately.

Susan testified at the FDA Advisory Committee Meeting on breast implants on August 30, 2011.