Myrl Jeffcoat myrlj@jps.net

29 mars, 2005 09:05

Rosella Rust Testimony - FDA Panel Hearings - October 2003

MS. RUST: (Read by Beth Nichols.) My name is Beth Nichols and I am reading this on behalf of Rose Rust who is too ill to be here today. I have no conflict of interest.

"My name is Rose. I am 57-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 had talked to a plastic surgeon and he told me they were safe and they 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  he surgeon and told him I thought they were making me sick. He told me I was listening too much to the media and he saw no reason to remove them. I believed him and left them in.

"I became more ill and the headaches became almost unbearable. I had so much pain that I had to quit my job. I had become so ill that I was put on Social Security disability. In the mid-'90s, my nasal passages started burning and my nose was swelling shut in addition to the horrible headaches. My GP sent me to a neurologist who did many tests and sent me to an ENT.

"I ended up having three sinus surgeries. The three different doctors all told me that something was inflaming my nasal passages. They told me that if I didn't find out what my body was reacting to, they couldn't help me. I went to an allergist and he found no allergies. We had our house checked for any toxins. My husband checked our vehicles. By now, I was feeling much worse, dizzy and nauseated.

"Over the next few years, I went to many doctors including the Mayo Clinic, but nobody could find out what was wrong with me. The last two or three years, I have become so ill I am almost bedridden. My nasal passages burn

all the time and my headaches are constant. My legs and feet burn, swell and hurt so badly, I can hardly walk. I am dizzy and nauseated. I have lost much of my short-term memory.

"Over the last few years, I have become intolerant of all chemicals. When I am exposed accidentally, my nose swells shut, nausea and headaches worsen and my heart acts up. In June of this year, I finally decided I was going to die if I didn't do something. In August, I had my implants removed. My left implant was ruptured and the plastic surgeon said most of the silicone had leaked out, migrating into my chest and into my lymph nodes. She described it as 'a sticky mess.'

"She also removed the lymph nodes with silicone in them. At that time, she told me there was probably silicone in my liver, lungs and brain. The right implant was intact. I have no idea how long the left implant had been ruptured. I saw no difference in how I looked.

"Through the years, I have become unable to even take care of my home. Sometimes, I am not able to fix meals for my husband. I spend many days in bed. Long ago, I gave up on social events. My husband tells me I actually am much worse off than I realize. It is just a struggle to survive. If the doctors had not told me my illness was unrelated to my silicone implants, I would have had them out many years ago and perhaps avoided much of the

silicone leakage.

"I think of how, in 1991, the FDA decided not to take silicone-gel implants off the market. It sent the clear message that silicone-gel implants are probably okay. I feel many of us have been the guinea pigs and I feel we have proven that silicone is not safe because the implants can leak throughout our bodies. It is too late to do much for women like me, but let 's please save the next generation.  "It is your responsibility to protect us and hopefully you can restore my faith in our FDA.  "Thank you."