A Strike Against Silicone

Since silicone breast implants were introduced 30 years ago, millions of women have sworn by their results. For most, the ample gel-filled sacs provided a welcome boost in self-esteem. For 1 out of 4 recipients, they brought a return to normality after the trauma of mastectomy. So when anecdotal reports of health problems associated with the devices began cropping up over the past several years, women were first alarmed, then hugely relieved when surgeons asserted that the stories were groundless. Now their confidence has once again been shaken.

Citing new evidence of health risks, Food and Drug Administration chief David Kessler last week declared a moratorium on silicone implants. He urged manufacturers to halt marketing the devices and surgeons to stop inserting them in women. In Spain and Australia health officials quickly followed suit; Canada, Britain and France are reviewing their policies. The decision stunned millions of women worldwide. "They are angry, frustrated and concerned," said Dr. Norman Cole, president of the American Society of Plastic and Reconstructive Surgeons. "They want to know what is going on."

Kessler's decision is based on evidence -- some of it still sealed under court order -- that has come to light since the FDA last reviewed safety information in November. At that time, an advisory committee recommended that the implants be left on the market. But studies released in the course of recent legal proceedings against Dow Corning Wright, the largest U.S. implant manufacturer, suggest that the company may have known about safety problems for years and kept them under wraps. Kessler said he has also received a number of case reports from rheumatologists linking the device to autoimmune disorders. The moratorium is in place until an expert advisory panel can review the new information; a final verdict from the agency is due this spring. Saline-filled implants, though less popular, are still available.

The latest information adds weight to several reports about the dangers of silicone gel, a substance also sold as a sealant and Silly Putty. If it stayed inside its envelope, the gel would pose little danger. But doctors have found that over the years it can leak into the surrounding breast tissue. In some cases, especially in poorer-quality implants manufactured between 1975 and 1985, the sacs rupture, spilling their contents into the body. The immune system's attempt to wall off this foreign chemical can cause inflammation and severe chest pain. Worse, the silicone can migrate to the lungs, liver and lymph nodes.

Once there, some experts fear, the gel may trigger a variety of autoimmune disorders as the body tries to protect itself from the perceived invader. These include scleroderma, which thickens and stiffens the skin and causes a buildup of fibrous tissue in the lungs and other organs; lupus erythematosus, which causes chronic joint pain and rashes; and rheumatoid arthritis.

The suspect gel has been linked to cancer in laboratory rats, according to a 1988 report. One type of implant, which has a polyurethane coating designed to prevent scar-tissue formation, poses a special danger, and was withdrawn from the market last April. The marshmallow-like foam coating has been shown to break down into a chemical called TDA (2-toluene diamine), which is known to cause cancer in animals.