A Strike Against Silicone

By ANDREW PURVIS

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.

Frightening anecdotes abound. Kali Korn, 41, of Los Angeles came down with scleroderma last year, a decade after she had silicone implants inserted for cosmetic reasons. The skin has so constricted around her fingers that she is virtually unable to move them. Doctors removed the implants in March, and she now says, "I feel much better. I wish I had realized 10 years ago that how I looked was fine."

But despite similar accounts from hundreds of women, scientists have yet to prove conclusively that implants are responsible for their woes. Critics of last week's FDA ruling, including many doctors, contend that the agency may have needlessly raised women's fears before convincing evidence was in. Cole feels that despite the court order, Kessler should have released the new information to the medical community before calling the moratorium. "We're getting hundreds of calls from women who want to know what this new information is, what it means," he said, adding that some women may avoid getting suspicious breast lumps checked for fear that there are no viable options for reconstruction.

Women are clearly worried -- and angry. Sheila Swanson, 49, of Saratoga, Calif., had implants inserted three years ago after a double mastectomy for breast cancer. Now she says, "I'm frightened. At this point, emotionally, I don't know how I could take another operation." Cindy Pearson, of the National Women's Health Network in Washington, has been pushing the FDA to act on this issue since 1983, and she is livid: "They've allowed over half a million women to get into this horrible quandary because they didn't order long-term studies earlier. If this were heart valves, or anything used by both sexes, the FDA wouldn't have gotten away with it."

For now, women who have implants are being urged to see a doctor only if they are experiencing suspicious symptoms. Kessler recommends that women check their breasts regularly for any sudden change in consistency or shape that might indicate a rupture. The commissioner emphasizes that the slight risk of , removing the implants probably outweighs any potential danger from leaving them in. That is some comfort. But for women who have grown to cherish their new breasts as a part of themselves, it doubtlessly is not enough.

With reporting by Elaine Lafferty/Los Angeles