
Photo Courtesy of Kathy Nye
Myrl Jeffcoat myrlj@jps.net
1 mai, 2005 09:29
Marti Jacobs Testimony - FDA Panel Hearings - April 2005
I’m Marti Jacobs from Arizona. I have no conflicts of interest.
Due to severe breast atrophy, I got silicone gel implants. I never wanted larger breasts, and I never would have gotten them had I known my health, career, and quality of life would be destroyed.
I was healthy, yet nine years later, I became very ill. Tomorrow, the industry will present only four years of safety data. If I had been in those studies, none of my problems would have shown up. Surely, we need long-term studies.
After nine years, numerous symptoms presented, such as: Abnormal white blood cell count, severe fatigue, discoid rashes, muscle and joint problems, numbness of my extremities, significant hair loss, etc.
These symptoms coincided with my right breast shifting lower than my left. It did not occur to me that the shift was anything but a slight change in breast tissue. Now, I believe this was when my right implant ruptured.
My medical records document Discoid Lupus, Sjogren’s Syndrome, Fibromyalgia and Chronic Fatigue Syndrome -- all common conditions for many women with implants. I had to go on Social Security Disability. The Social Security Administration determined the date of onset of my silicone-related illness was nine years post-implantation.
Twenty years after implantation, a mammogram report concluded there were no ruptures. Just months later I had my implants removed only to find both were, in fact, ruptured. According to my Operative Report, quote:
"On the right side there was total disruption of the implant and no visible shell was seen. On the left side, there were also several gross ruptures of the implant. It was obvious that the implants had been ruptured on both sides for quite some time."
Upon removal, my neurological problems have somewhat improved, but I still suffer with debilitating chronic fatigue, and much more. Perhaps, there is still silicone in my body. As you will hear from the company data, most women do not even realize when their implants break, and mammograms are not reliable to tell them either.
MRI’s have been proven to be more reliable, but how will women afford them?
How would women get an MRI immediately upon a rupture?
How will women afford and receive the urgent removal surgery?
This is why so many women have been exposed to leaking silicone.
What possible reason can these companies have for never providing you with long-term safety data - especially when women like me have expressed our concerns over and over again?
I question whether silicone gel implants can ever be proven safe, and ask you – If it is against the law to inject silicone gel into women’s breasts, what on earth makes it okay to put it in a breakable baggie?
Since we know implants break down and rupture; wouldn’t it have to be proven safe for gel to be inserted directly in breast tissue? That’s what a rupture is.
If you approve these implants, you will not be protecting women, because they will believe they are safe, when clearly this has not been proven.
Please just say NO.