Statement by Sherry Henderson
General and Plastic Surgery Devices Panel Center for Devices and Radiological Health Food and Drug Administration, DHHS
October 14, 2003
My name is Sherry Henderson and I am from Bossier City, Louisiana.
I had fibrocystic breast disease and precancerous cells, which resulted in a double mastectomy and reconstructive surgery with implants. During my first year of implants I had chest pain and headaches; within the next three years I had hair loss, muscle spasms, irritable bowel syndrome, reflux muscle pain, and rashes.
By the eleventh year, a sonogram verified a silent rupture and I had my third surgery with a tram flap; that was a six-hour surgery.
I was fortunate to see a doctor who had studied implanted women for over twenty years. I was diagnosed with several diseases, included Lupus likeness, rheumatoid arthritis, fibromyalgia, myositis, organic brain syndrome, high blood pressure, and autoimmune diabetes. I’m on disability.
I would like to ask the FDA to have the implant makers do at least ten years of research. They should be required to pay for a national implant registry, and require all women in it to have yearly screening examinations for local and systemic complications. Let unbiased researchers do the screening.
The Inamed research shows very high complication rates and an increase in fatigue and other symptoms in just the first two years after getting implants. But, to know the real consequences, we must have longer research.
Breast implants are not life-saving devices. If they are not safe, they should not be approved.
I live in pain every day and I pray that my grandchildren and nieces will not have to go through the pain I have gone through. The higher rate of brain and lung cancer, more suicides, and the study linking leaking implants to fibromyalgia are warnings that silicone gel should be made less available, not more available.
We are tired of all the suffering. There are young women becoming 100% disabled and the government is finally coming after the manufacturers. If the FDA refuses to approve this defective product, the implant makers would do better research and develop safer implants.
In the past, the FDA ignored hundreds of thousands of adverse reports sent to them dating back to the 1970s. Breast implant women have copies of these reports and would gladly provide them for anyone to see. These reports documented horrible health problems and unbelievable complications with these devices.
Please make the right decisions for the sake of women who trust your opinion and whose lives depend on that trust.