
Myrl Jeffcoat
myrlj@jps.net1 mai, 2005 19:08
Carolyn Wolf Testimony - FDA Panel Hearings - April 2005
MS. WOLF: Good morning. My name is Carolyn Wolf. I live in Virginia, and I came here at my own expense. I have no conflicts of interest.
In 1972, after subcutaneous mastectomies, I had reconstruction with the newest, best construction, silicone implants, that were safe and would last my lifetime.
There were no problems in the beginning. By the seventh year, burning, blister?like growths started on my neck and boil?like growths on my forehead. Sixteen years after, three days were spent in ICU because of severe burning chest pains.
By the 21st year, my family had noticed a change in personality. And I had noticed cognitive changes. By the 25th year, though a non?smoker, I was coughing up hard, greasy, gold?colored plugs. X?rays showed chronic obstructive pulmonary disease.
A military plastic surgeon checked me every year. I never connected my problems with the implants until my left breast capsule collapsed 28 years after implantation. MRI showed both implants extensively ruptured. Shortly thereafter, a glob of silicone moved from my breast into my armpit, leaving an elongated swelling in its path. There was excruciating pain.
In April 2000, vision was lost in my left eye for 45 minutes. Pain continued in that eye until a long, stringy glob came out of it several weeks later. Two similar strings were exuded from my left ear in the 30th year.
Explantation performed in 2000 showed the left implant measuring only four centimeters. The scar capsules surrounding the implants contained chronic inflammation and foam cells containing silicone. Few women had implants as long as I.
I have been diagnosed with silicosis, rheumatoid arthritis, connective tissue disease, Raynaud's, and silicone?induced MS?like syndrome with neuropathy of the extremities.
My brain MRI shows more than 20 lesions. My silicone level is .11, more than double what is normal. My platinum level is 20 times normal. Silicone continued to be exuded from my nipples until simple mastectomies to remove painful calcified tissue was performed six months ago.
National Cancer Institute has conducted the only study of women implanted for more than eight years. That found women are much more likely to die of brain and lung cancers and suicide. If implants are so safe, make sure that manufacturers prove that it is safe.
The studies you will hear about tomorrow do not prove that. The women studied were not implanted for more than ten years. You have no control over the advice given or not given by plastic surgeons. What happened to me will eventually happen to thousands of women with silicone implants. And please do not inflict this on another generation.