Statement by Susan Pope Helman, Ph.D.
General and Plastic Surgery Devices Panel Center for Devices and Radiological Health Food and Drug Administration, DHHS
October 15, 2003
Good Morning. I am Susan Pope Helman, Ph.D. and I am from Florida.
As I speak, pretend I am your wife or someone you love very much.
A little over 13 years ago, I was normal. I had two children and took care of my Mother who had Alzheimer’s Disease, while I worked two jobs and put myself through college. I was a productive tax-paying Mom who enjoyed golfing, swimming, bicycling and long walks in the mountains and on the beach. I never missed a day of work.
Then, September 6, 1990, I made the biggest mistake of my life. I trusted my plastic surgeon who stated silicone breast implants were SAFE, that they will last a lifetime, and I would “go to my grave with them.” I assumed they wouldn’t be available unless the FDA had determined they were safe.
Boy, how wrong that was!
Within about 6 months I started getting horrible headaches, couldn’t think “right”, and noticed I was dizzy and nauseated much of the time. I would lose my balance and feel like I was going to fall down.
I couldn’t figure out why!
The second year, all of my hair fell out. I was diagnosed with fibromyalgia. I could not concentrate, and I seemed to be in a “fog” most of the time.
When the pain would come I would thrash back and forth in bed and could not focus or see or get up.
My life was destroyed.
I lost a wonderful job, my car, my salary, my home, my productivity and sense of well-being as a person.
The illnesses began with a vengeance around 1997. Both breasts burn like they are on fire and throb with pain. I have sores, blisters in my mouth and on my hands that bleed and boils on my bottom most of the time.
I wondered why I felt so bad. I had the implants removed in 1992. The implants were in my body less than 2 years!
In 2001, I found out the reason. The capsules which contained bacteria, silicone and giant T-cells were left inside my body and continued to make me more sick.
I also found out both implants had ruptured and all of the silicone was never accounted for. The silicone had migrated throughout my body. I have had brain scans that show many lesions–I was told that I had the brain of an “old lady”–and other tests that show polyneuropathies, multiple sclerosis, lupus and autoimmune disease.
Two years ago, a plastic surgeon removed the remaining capsules and silicone that spilled out into my chest wall, as well as much of my breasts and several lymph nodes and scar tissue. She stated she “was unable to remove it all.” And Susan, “You must live like this for the rest of your life.” I continue to receive cortisone injections every three months to help control the pain.
I was treated like a guinea pig in a horrible experiment that never should have been allowed to happen!
Without the Grace of God and my husband I don’t think I ever would have made it through the whole ordeal. I have been told I will never totally recover.
If FDA approves these silicone gel breast implants, we know that women will be told the FDA says they are “completely safe”. How many more women will have to go through the problems caused by broken implants, as I did?
I really want this panel to seriously consider the experiences of women like me. If you doubt that all my problems are caused by breast implants, then just think about the ones that OBVIOUSLY are: the breast pain, the silicone throughout by entire body, the devastation of losing my own breasts because of silicone leakage.
My hopes are that you will make it clear that a company that wants to sell breast implants needs to provide at least ten years of good data before expecting their implants to be approved by the FDA.
This testimony was presented to the FDA by Dr. Helman on October 15, 2003.