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alexlannin
04-12-2005, 03:38 PM
By LAURAN NEERGAARD
WASHINGTON (AP) Thirteen years after most silicone-gel breast implants were banned, federal health advisers on Tuesday narrowly rejected a manufacturer's request to bring them back to the U.S. market, citing lingering questions about safety and durability.

Inamed Corp. had argued that today's silicone implants are less likely to break and leak than versions sold years ago. But the Food and Drug Administration was skeptical, and its advisers voted 5-4 that the company hasn't provided enough evidence about how long the implants will last and what happens when they break and ooze silicone into the breast, or beyond.

Without that information, "How can we get an informed consent from our patients?" asked FDA adviser Dr. Amy Newburger, a New York dermatologist. "It makes me very uneasy. ... I don't feel secure about the safety."

That doesn't mean the implants can never be sold, the advisers stressed. No one expects the implants to last a lifetime, but at the very least women need evidence about how likely they are to last 10 years, panelists stressed.

"All of us feel very strongly that women have a choice," said Dr. Barbara Manno of Louisiana State University. But she ultimately opposed lifting the ban because Inamed has tracked patients for only three or four years to check implant durability. She cited concerns that the older the implants get, the more likely they are to rupture.

The decision came after emotional testimony Monday pitting woman against woman: dozens who said implants broke inside their bodies to leave them permanently damaged, and others who want implants they say feel more natural to repair cancer-ravaged breasts or make their breasts bigger.

On Wednesday, Inamed competitor Mentor Corp. will try to change the FDA panel's mind. Mentor is seeking FDA approval of its own silicone implants, but hasn't tracked patients any longer than Inamed did.

The FDA isn't bound by its advisers' recommendations and the panel's vote was a surprise. This same panel, with a few different members, had narrowly recommended allowing Inamed's implants back on the market just 18 months ago, a decision the FDA rejected because of durability concerns.

"Obviously we're disappointed," said Inamed Vice President Dan Cohen, who pledged to work with the FDA to get the necessary additional evidence as soon as possible.

Silicone-gel implants were widely sold in the 1970s and '80s until health concerns prompted the FDA in 1992 to limit their use to women in strict research studies.

The implants have largely been exonerated of causing such serious or chronic illnesses as cancer or lupus. But they can cause side effects, including infection and painful, rocklike scar tissue. Also, they can break, requiring additional surgery to remove or replace them and the FDA and some panelists say questions remain about how often silicone then oozes into the body. The health consequences of such leaks are still in question.

About 14 percent of implants will break within 10 years, Inamed officials told the FDA panel Tuesday, an estimate derived from a study of 940 patients tracked for three or four years.

Just one in 20,000 implants will leak silicone gel beyond the immediate implant area, the company contended. In its study, women whose implants broke reported no more complications than women with intact implants.

Preliminary FDA analyses, in contrast, suggest up to three-quarters of implants will break within a decade.

Why the difference? The FDA assumes that, like many medical devices, as an implant ages it will become more fragile. Inamed's estimate assumes the same percentage of implants will break each year and it blames most of the breakage on surgeon-caused damage at the time of implantation.

That makes no sense, responded FDA adviser Stephen Li, a device-testing expert from Sarasota, Fla. "The odds of creating a series of nicks and cuts ... and it just so happens the same number of them break every year, it's almost fantastic," he said.

But Inamed argued that the salt water-filled implants sold today don't break at a faster rate as they age, and that silicone implants are just as durable.

The Roman Candle
04-12-2005, 03:40 PM
I oppose them, too.

WAKKAJAWAKKA
04-12-2005, 03:41 PM
My "Panel" Doesn't.

Wayno.