FDA set to reconsider allowing silicone-gel breast implants

WASHINGTON -- Eleven years after most use of silicone-gel breast implants was banned amid fears they were dangerous, the Food and Drug Administration is considering letting them back on the U.S. market.

Revisiting the emotionally charged issue, the FDA next week will hear testimony essentially pitting woman against woman -- some who say the implants broke apart to leave lasting scars, others who want implants they say feel more natural to reconstruct breasts savaged by cancer.

Inamed Corp. of Santa Barbara, Calif., reopened the controversy by asking the FDA for permission to sell its version of the implants in the United States, like it long has in Europe. A competitor also is expected to seek FDA approval soon.

Feminist groups and other critics say questions about long-term side effects when silicone gel leaks from the implants haven't yet been settled, and that, at the least, women face pain and repeated surgeries when the implants break. Newspaper and TV ads set to run nationwide depict implants as ticking bombs in women's bodies and charge that the FDA is bowing to industry pressure to restart sales.

Implant recipients "are really gambling with their health because there isn't really good long-term research on safety," said Diana Zuckerman of the National Center for Policy Research for Women & Families.

Proponents say implants have been thoroughly studied and exonerated as disease-causers, and that recipients are well aware that breast implants, just like pacemakers or metal hips, don't last forever.

"There are some moral judgments being played on here about women who choose to have their breasts enlarged," said Dr. James Wells, president of the American Society of Plastic Surgeons.

Inamed says its studies show silicone gel-filled implants are as good as or better than the salt water-filled models now on the market. "We believe women should be able to have that choice," said JoAnn Kuhne, a top company official.

Independent study

Next week, the FDA will turn to a panel of independent scientific advisers that will hear debate for two days, including eight hours devoted to public opinion.

At a small protest Wednesday in Washington, Anne Stansell held a sign that said, "I survived breast cancer, will I survive breast implants?"

The 57-year-old from Los Lunas, N.M., had breast implants for eight years after a double mastectomy. She had them removed after suffering memory problems, skin disorders and pain. Why does she link the symptoms with the implants?

"When I had them in, I got sick," Stansell said. "When I took them out, I got better."

But Sandee Stern, 58, of Chicago, longs for a new silicone implant. She received a pair in 1991 after cancer surgery, but five years later, one implant broke and she was forced to get a saline-filled replacement.

It doesn't feel as natural -- that breast has become wrinkly like a deflating beach ball, while the silicone-filled breast remains taut, Stern said in a telephone interview.

"It's just not fair that I can't say I want to have silicone implants without having to be followed around," she said. "I made an informed decision and I think most women today do that."

Breast implants began selling in 1962, before the FDA required proof that all medical devices are safe and effective. Complaints that they broke and caused illnesses began in the late 1980s, and in 1992 the FDA banned implants filled with silicone gel except for patients with breast cancer or a few other conditions who could get them by enrolling in carefully monitored research studies.

Thousands of women sued the makers of silicone-filled implants; many suits ended in a major settlement approved in 1999.

That same year, the Institute of Medicine declared there was no evidence that implants cause major illnesses like breast cancer or lupus, but warned they do frequently break open to cause pain, disfigurement and repeat surgery.

Studies published more recently, including one by the National Cancer Institute, raised questions about other potential risks, such as whether implant recipients are more likely to commit suicide.

Meanwhile, implants filled with saline, or salt water, were not restricted, the only choice left for breast enlargement. In 2000, FDA formally approved saline-filled implants, and last year 236,000 women had breast enlargements, six times more than a decade earlier. Inamed says that in countries where both saline and silicone implants are sold, 90 percent of recipients choose silicone.