FDA MAY LIFT BAN ON SILICONE BREAST IMPLANTS TRACKING RECIPIENTS' HEALTH FOR 10 YEARS RECOMMENDED.

Byline: Michael Gougis Staff Writer

Government science advisers recommended on Wednesday the lifting of an 11-year ban on silicone-gel breast implants but suggested tough new conditions on use of the controversial device.

The Food and Drug Administration advisory panel voted 9-6 to recommend allowing Inamed Corp. to resume sales of silicone implants, which were banned in 1992 over concerns that they contributed to painful and serious medical disorders.

Research presented to the panel suggested that silicone implants break no more frequently and cause no more problems than saline-filled implants, the only alternative now available in the United States.

But because of lingering concerns over the product, the panel recommended that Inamed be required to track women with the silicone implants for 10 years after the surgery. Women seeking silicone implants should also be given literature detailing the known risks of breakage or leakage and must enroll in a registry to track their health.

The panel also recommended that women with silicone implants receive annual examinations to determine whether the silicone is leaking. While a leaking saline implant will deflate quickly, alerting the patient, silicone implants can leak slowly over a period of years.

Although more than 90 percent of breast-implant recipients in Europe choose silicone, after the U.S. ban only women with breast cancer and a few other patients who are enrolled in tightly controlled research studies have received silicone implants in America.

Since 1992, American women who wanted implant surgery had to get saline-filled implants. Last year, more than 236,000 women had breast-augmentation surgery in the United States.

Dr. Stuart Linder, a Beverly Hills surgeon who specializes in breast reconstruction and augmentation, said if the FDA follows the panel's recommendations - which it typically does - women will have an option besides the saline implants.

``There are several significant advantages. They feel much more real, much more natural, and there's no rippling. That's what women hate about saline - they're like water bags that ripple,'' Linder said.

Critics said the lack of long-term safety data should have deterred the panel from recommending approval.

``We did not have enough long-term data ... to assure safety,'' said Dr. Ellice Lieberman, a doctor at Brigham and Women's Hospital in Boston and panel member who voted no.

Studies have shown no concrete link between the silicone implants and major diseases such as breast cancer, lupus, arthritis and other autoimmune disorders. But scientists have warned that those studies were too small to identify rare diseases or identify small subsets of women who might be more vulnerable to complications.

However, in a three-year study, one in five women who received silicone implants for cosmetic purposes - and 46 percent of cancer survivors - needed additional surgeries to treat pain, scarring and other complications.

The Associated Press contributed to this report.

Michael Gougis, [phone]

michael.gougis(at)dailynews.com