Myrl Jeffcoat myrlj@jps.net

MR. MILLER: My name is Steve Miller. I have no conflict of interest. My wife is here today. And she will be sharing her story about how silicone implants she received for correction of a congenital defect have harmed her.

I am reading this testimony on behalf of another man whose wife has also suffered greatly due to silicone implants. I am here to read the testimony of T. Wade Clegg of Panama City, Florida who could not be here with us today. He has no conflict of interest.

"My family life has been severely affected by my wife's disastrous experience with silicone gel breast implants. That is why I wish to share my thoughts with the Advisory Panel.

"I believe that silicone gel is one of the most insidious and invasive products ever allowed in the public marketplace. Silicone can migrate to distant places within the body, such as the liver, thyroid, under the arms, into the arms, and across the chest. Such was my wife's experience.

"For years, her neck would swell and diminish, blocking her breathing. Her thyroid was removed, and the pathology report said it was Sjogren's disease. She is now on permanent medication and must wear a 24-hour opium patch.

"Sjogren's disease, by the way, can take years to diagnose. Only long-term studies will be able to show whether implants cause this disease.

"My wife was not informed about the dangers of silicone breast implants. She is serving a life sentence of pain. Normal for my wife has become a loss of physicality, loss of sleep, and diminished health, which has led to massive medical bills, bankruptcy, the loss of our farm, and a downward spiral resulted from silicone gel breast implants.

"Most women do not know that silicone gel can calcify and mix into breast tissue. The pain can be extreme, as in my wife's case. Once this takes place, the surgeon has to literally scrape the silicone off the chest cavity until there is nothing left. This was my wife's experience.

"My wife no longer has breasts. For women of childbearing age, this is particularly devastating and can mean the inability to breast? feed.

"The FDA had questions about the safety of implants last year and didn't approve the application for implants back then. The real question is, have the manufacturers really answered all of these questions in the space of one year? Since only four years worth of data is being presented, I doubt it.

"Please ask yourself, if the same question exists, then why are we here? I plead with this FDA Advisory Committee to continue to restrict silicone gel implants while research continues. Do not improve implants which have not been proven safe for long-term use. This is not about aesthetics. It's about women's health.

"Thank you."