Wanda Shatley

North Carolina

I was diagnosed with a precancerous tumor in 1987, and after a lumpectomy I used McGhan silicone gel implants.

I developed aches and pains, eye problems and a general feeling of unwellness within 2 years, and was diagnosed with fibromyalgia in 1992.

I saw over 60 medical doctors in North Carolina, Florida, Texas, Connecticut and New Jersey, who could not give me a definite diagnosis for my illness.

I became blind in my left eye and my health rapidly deteriorated. I’ve been bedridden with dozens of symptoms since June 1993. I have been diagnosed with MS and lupus. I was hospitalized for 10 days at St Mary’s Hospital, in Connecticut, where they found lesions on my brain and spinal cord, and an ANA of 180.

I was then transferred to a different hospital where I spent another 53 days getting stabilized and prepared for explantation. My implants were removed in 1993, and the right implant was leaking. I was hospitalized a total of 180 days within a one year period due to illness and toxicity from breast implants. I was explanted on my birthday, September 22, 1993, and felt better within 24 hours.

I spent $300,000 on treatments not covered by insurance and re-location to Houston, TX for 18 months. Gradually, my health has improved and most of my blood work is back to normal. I have not developed new lesions on my brain or spinal cord. My brain fog improved greatly after explantation, but depression is still a huge factor. I can’t handle stress of any kind. However, I no longer have a diagnosis of fibromyalgia.

It is the FDA’s job to approve medical implants that are safe and effective. I understand that cancer patients need some form of reconstruction, but it should be safe, not almost safe.

Meanwhile, the U.S. Department of Health and Human Services is suing breast implant manufacturers for Medicare health costs of ill breast implanted women. Where is the logic? What information that the company provided would convince me that breast implants are now safe?

This testimony was read for Ms. Shatley at the FDA hearings on October 15, 2003.