Kathy Nye

Pennsylvania

My name is Kathleen VF Nye and I live in Sinking Spring, Pennsylvania.

I know from experience that silicone gel implants will adversely affect the lives of many people if they are approved based on just a few years of safety data. Not only are the women who would be implanted at risk, but also there is a trickle down effect, affecting the whole family.

Inamed says that their new and improved silicone breast implants are safe.

I would like to relate my story of new and improved silicone breast implants. My first experience was in 1968. I was 22 years old and had a bilateral mastectomy.

These new devices started to get hard after 6 months. I also started having fatigue and joint pain. In 1976, I found a doctor who would remove the implants. The replacements also hardened and had to be removed in 1981. The doctor told me there was a new and improved version and they would not get hard. I had the new and improved implant inserted in January of 1981. On February 14, 1981 the left implant had to be removed and later replaced.

This new and improved silicone implant started to harden, again at about six months. I waited three years, until I could not stand the pain any longer. Again I went to the plastic surgeon and told them to remove the implants. I did not want another set, but again I was told about a new and improved silicone breast implant. So again I had the new and improved silicone breast implant inserted in January of 1983.

I started to feel lumps around the edge of the new implant. There were three masses on the right side. The cancer was sandwiched between two masses of “foreign material,” with giant cells.

This started me on the road to more implant disasters. I had a total of 13 implants, including devices made by McGhan –a company that is now called Inamed. In the early 1990’s, the implant came through the skin and popped out on its own. Here is my photo. By 1992, after having a hole in my chest for years that would not heal, I had to have a tram flap.Kathy Nye

I have been on disability since 1986. I have been diagnosed with asthma, fibromyalgia, abnormal liver function, depression and early Parkinson disease, among other things.

I am sure you understand my concern when I heard that the manufacturers are now trying to promote a new and improved silicone breast implant. Talk is cheap. It’s easy to call an implant “new and improved’ but you won’t know if it really is better until it has been inside a woman’s body for 5 or 10 or 15 years. I urge you to not be as naive as I was when I was told they are better than the old ones. I hope the FDA will not put these “new and improved” silicone gel implants back on the market unless they have been tested for a long enough time to really prove they are safe.

This story was presented by Kathy Nye as testimony before the FDA in October 2003.