Statement by Susan L. Cunningham
General and Plastic Surgery Devices Panel Center for Devices and Radiological Health Food and Drug Administration, DHHS
October 14, 2003
My name is Suzy Cunningham and I came here at my own expense.
My biggest concern is that these implants rupture, and there is still no medical information on how to recognize a rupture and what to do about it. It is a frightening experience to be so sick and not have a clue what is wrong with you. Many women can’t afford an MRI to check. And, even if they find out their implants are ruptured, many don’t have the money needed for surgery.
My own experience began after I had breast-fed both of my children and my husband was no longer happy with my appearance. He suggested implants and arranged for a consultation with a respected plastic surgeon. I had concerns, but the surgeon said the implants would last a lifetime.
I was fairly pleased with the results but it didn’t last long. I began to experience loss of nipple sensation and numbness. Then I experienced capsular contracture in the right breast. On top of all that, I found out that my husband had been having an affair for some time and I decided to terminate the marriage of 18 years.
As the years went by, I was plagued with sinus and respiratory problems. I remarried, but my health continued to decline. Finally, in l993, I consulted my plastic surgeon. As he wrote in his notes “I reassured her concerning this and advised her to leave her implants in place unless there are further difficulties because they look very good.”
My body was wracked with joint pain. I was diagnosed with Raynaud’s and suffered from constant muscle spasms. My breathing and chest pain were severely affected and I had been in the emergency room several times. Finally, tests indicated “fairly remarkable changes” in my immunological system “characterized by an unexplained decrease in the total CD-4 or helper cells.”
I was getting sicker and experienced a fatigue so devastating that I would weep from the smallest effort. My concentration was zilch and I started having huge gaps in my memory – Like pulling out of my driveway and then wondering where I was going or what I was doing in the car.
It was frightening and became worse. Finally, I was forced to quite a career that I loved . At this point it became necessary to sell the family home.
I was praying for answers and help finally came from a family member, a cousin who had just finished medical school but had become too sick to work. She told me that she had had ruptured implants and symptoms like mine.
I sought out Dr. Feng whose practice was 120 miles away. She informed me that at least one implant was ruptured. They were removed in l995 and I promptly noted relief in the chest pain I had been experiencing for years. Within a few months my blood work returned to normal except for IgE levels and a positive antihistone antibody, which took an additional two years to return to normal.
My overall physical condition has taken a few years to improve. I still suffer from fibromyalgia- like symptoms though attacks are less frequent and of shorter duration. At the ripe old age of 6l, my mind is much sharper and my body much stronger than it was just a few years ago. My infections have become infrequent, which is good because I find myself pretty resistant to antibiotics.
Today I live a life far different than one I could have lived if it were not for ruptured implants and their devastating effects. My husband and I have been through a terrible time but our marriage has endured and become stronger. However, I am certainly not the involved wife, mother and grandparent I had hoped to be, and I am now on disability, which was granted on silicone rupture and related problems. It was a very black day for me to finally accept the fact that working is no longer an option for me.
I am not looking for pity because I have been blessed with many other things in my life. But if there is anything I could do to help other women to avoid the devastating effects of ruptured or leaking implants, then I have to try. That’s why I am asking you to not approve silicone gel implants until the company provides long-term safety data proving that leaking silicone and autoimmune diseases can be avoided. The company’s application for silicone gel breast implants was rejected in 1991. They had 12 years to collect data, but only collected three. They will only do better research if approval is denied until they do.
Ms. Cunningham presented her testimony to the FDA on October 14, 2003.