Eileen Swanson

New Jersey

I was diagnosed with Stage II breast cancer in May 1988, after which I had a modified radical mastectomy. In July of 1989, the doctors (including a cancer researcher) determined that I was at high risk for a second primary tumor in the other breast, and I made the decision to have a prophylactic contralateral mastectomy with implants. I opted for saline-filled, because by then there was some talk of silicone gel-filled implants leaking.

Two Mentor saline smooth-shell leaf valve implants were surgically implanted in my chest cavity in July of 1989. The right one deflated in the recovery room. My left side had difficulty healing and there was a lot of swelling, including a swollen lymph node on the left side. I experienced a dizzy spell that required a brain scan. The results of the brain scan were normal, even though my “breasts” were extremely painful after the implant surgery.

In January 1990, the right implant was replaced with a Dow tissue expander, saline implant only. It was filled weekly with saline over a period of around 8 weeks, which was a very painful process requiring Valium and/or Tylenol with codeine. Then a 3rd surgery replaced both my right and left implants with Mentor saline Siltex implants, with textured shell. They hardened almost immediately, and again I had difficulty healing. There was a lot of oozing and swelling. The left side swelled up all the way to my collarbone, and remained swollen until the saline implant was explanted. At one point the implant could even be seen through my wound.

In less than a month, I suddenly became ill with symptoms of widespread joint and muscle pain, stomach cramps and diarrhea, overwhelming fatigue, hair loss, morning “stiffness” so severe that I could barely get out of bed, and a sleep disorder that I later learned is called “fragmented sleep.”

My plastic surgeon told me that my symptoms were similar to those of silicone gel implant patients. She also told me, for the first time, that the shells of my saline implants were made of silicone. I decided that I wanted the implants out, but by then I had different doctors at the military hospital (my husband was in the military), and they refused. I waited for six months until I was finally explanted in May of 1991. Small incisions were used to deflate the implants of saline and then the shells were pulled out. By the time I got the implants removed, I could not even do stretching exercises, and as a result, my photography business was nearly at a standstill.

I had a brief reprieve, but the illness continued. The pain was unrelenting, and at times so excruciating that I was bedridden and disoriented. My doctors shrugged their shoulders. They had no idea what to do for me.

In 1993, I was diagnosed with fibromyalgia and assured by my rheumatologist that some medication for sleep, followed by increasing amounts of exercise would easily manage the disorder. Having been athletic and very active my whole life, I was ecstatic.

But it did not work out that way. The medication made me so drowsy that even a quarter-dose made me too sleepy to work the next day. I was forced to stop taking it after a few weeks. Aerobic exercise was a distant memory. My rheumatologist had no suggestions for another medication at that time.

In April 1994, I had extreme fatigue, incredible pain, and was suffering from memory loss. I was forced to close my photography business. I realized that I was having difficulty remembering the myriad of details that photography requires.

Sometime in 1994, I learned that in order to insure maximum removal of the silicone, the scar tissue capsules have to be removed. Unfortunately, mine were not. Because the capsules are located under my muscles, I am told that to remove them now could do more harm than good. There are no guarantees that they can be removed fully intact. There is a possibility that the doctors would have to scrape the capsules off my ribs.

In 1997, duodenal ulcers were added to the myriad of problems that I already had. Therefore, most medications (pharmaceuticals, OTCs, and alternatives) and foods are now off limits. I have tried 5 medications for sleep, 6 for ulcers, and 7 for pain. Right now, I can only take Klonopin (chewed), for sleep or pain.

I have every symptom that is listed as being associated with fibromyalgia in the ACR classification. Irritable bowel, Raynaud’s, and cognitive dysfunction, along with the other symptoms I have described.

My marriage ended in divorce. I am on disability and live with my mother in her attic bedroom. I have a friend who recently returned to work following being similarly ill from implants. It cost her $40,000-$50,000 in treatments that are not covered by insurance. I have little hope of being able to do those things since I have no money. I do not expect to receive much from Dow. I received very little from Mentor.

I had 5 saline implants. They were supposed to be safe. I try to tell myself that maybe I would have become ill anyway, however, I have no family history of this sort of illness. And if it is not residual silicone that makes my chest burn constantly, then what?

Many of us pray that our government and the medical community will finally recognize what is making us ill, and do something to help us. I cannot tell you what a relief that would be.

Most of my doctors still are unable to help me, and do not recognize silicone-related illnesses. I have even been laughed at by a rheumatologist because I suggested that my implants had made me ill. Another doctor told me that it was strictly a lawyer-driven, hysterical-women, greed issue. Which, of course, would account for why I live on $560 a month, and why I gave up my dream profession to live this way!

I just want to get well. I just want my life to stop being such hell with no end in sight.

This is Ms. Swanson’s testimony before the FDA Advisory panel on March 1, 2000.