Chelsea C.

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.