26 mai, 2005 20:00

MS. VAN FOSSEN-NYE: Good morning. My name is Kathleen Van Fossen-Nye. I drove here from Sinking Spring, Pennsylvania to speak before the panel. And I have no conflict of interest. I spoke before the panel in October of 2003.

My history with silicone breast implants is almost as long as the products have been on the market. In 1968, when I was 22 years old, I was implanted with the original Cronin implant following a bilateral mastectomy for a precancerous condition.

A military doctor performed my first breast implant surgery because my husband was in the U.S. Navy. In the government lawsuit, manufacturers agreed to pay five government agencies, including the Department of Defense, the Department of Veterans Affairs, Medicaid, and Medicare, millions of dollars to reimburse them for the costs they incurred treating women made ill by silicone breast implants. This settlement demonstrates that the federal government is aware and has acknowledged that silicone breast implants cause health problems and disabilities.

However, how can the FDA even consider approving these PMAs when the Department of Health and Human Services has already made it clear that silicone breast implants pose a serious health risk to women, costing millions of dollars?

In the past, I have heard the panel members ask why so many women get breast implants and why they keep getting them, even after they fail? I have heard plastic surgeons on the panel say that the women don't mind the complications because they really like their implants. This was not true for me.

I started to suffer from fatigue and joint pain, and the implants were hard and painful. I went to a number of plastic surgeons, asking to have my implants removed. I found a plastic surgeon who was willing to remove the implants. He removed and replaced my implants with a new and improved implant. This started my journey through a silicone nightmare.

I have experienced the gamut of problems, including outright rejection. Eventually necrosis developed, and the implant actually came out through my skin and popped out on its own. Here is the photo of what happened.

Despite my mastectomy, I developed breast cancer in '86. I have had a total of 15 implants and expanders over the years. Why did I have 15 implants? I had so many because I believed my doctors when they told me they were new and improved. I wanted to believe my doctors when they told me they were new and improved.

For over 35 years, I have experienced new and improved implants. I have come to the conclusion there is no such thing as a new and improved silicone breast implant.

Kathy Nye