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FDA Panel Says No To Silicone

Silicone-gel breast implants haven't been proven safe enough to lift a 13-year near-ban on their use, federal health advisers narrowly ruled Tuesday.

Manufacturer 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 on Tuesday that lingering questions about how long the implants last — and what happens when they break — must be answered before the implants are widely sold.

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."

The decision came after emotional testimony pitting woman against woman Monday: 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.

The FDA isn't bound by the recommendation, and will vote again Wednesday on the request of a second implant maker, CBS Evening News reports. There's no word when the agency will make its determination.

That doesn't mean the implants can never be sold, the advisers stressed. No one expects implants to last a lifetime, but at the very least women need evidence about how likely they are to last 10 years, many 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 answer that question, and there are signs that the older the implants get, the more likely they are to rupture.

The Food and Drug Administration remains skeptical, saying significant questions remain on how long the implants last inside a woman's body — and the health consequences when they break.

"In fact, we really don't know" how many implants will last even 10 years, FDA statistician Pablo Bonangelino told the agency's scientific advisers as the panel debated Inamed Corp.'s attempt to resume widespread sales.

Silicone-gel breast implants began selling in 1962, before the FDA required proof that all medical devices are safe and effective. The implants were banned back in 1992, after thousands of women complained they ruptured and caused immune system diseases, joint problems and even suicides. But medical studies have never been able to prove the link, and now only women who have had breast cancer can opt for silicone, reports CBS News Correspondent Elizabeth Kaledin.

Thirteen years later, the implants largely have been exonerated of causing serious or chronic illnesses such as cancer or lupus. But the implants can cause side effects, including infection and painful, rocklike scar tissue. Also, they can break, requiring additional surgery to remove or replace them — and those ruptures can result in silicone oozing into the breast and, sometimes, farther into the body.

Just last year, the FDA rejected Inamed's request to lift the near-ban until those durability questions are better answered.


Now Inamed and competitor Mentor Corp. want FDA to reconsider, arguing that thicker shells and stickier silicone make newer versions safer — and that U.S. women deserve the option. Silicone implants look and feel more natural than the salt water-filled implants on the U.S. market, and they are far preferred in Europe where both types are sold, they say.

It's an emotional issue. In an extraordinary daylong hearing Monday, dozens of women pleaded with FDA not to lift the near-ban, telling of silicone globs oozing from their bodies after implants broke, and years of pain even after they were removed.

Don't be swayed by the emotion, Inamed chief scientific officer Dr. Patricia Walker told the advisers Tuesday. "As horrible and heartbreaking as these testimonials are, we must rely on science," she said.

Inamed tracked 940 patients for three years. In those who had breast enlargement, just 2 percent broke in that period. But 10.6 percent of breast cancer patients suffered breakage in that time period, a difference Inamed attributed to a particular implant model popular for breast reconstruction — a model it says it hopes to redesign.

Those breakage rates suggest that 10 years after implantation, about 14 percent of implants will have ruptured, Inamed concluded.

But FDA scientists sharply criticized that estimate, saying in fact the implants likely will break more often with age — and that as many as three-quarters might break within a decade.

Moreover, in Denmark, which more closely tracks implant recipients, one study suggests nine of every 100 implants may break each year, noted FDA scientist Dr. Sahar Dawisha. Calculating with those odds, some 22,500 implants a year might break in this country if silicone-gel models were widely sold, she said.

It's impossible to tell which estimates are right, FDA's advisers concluded Tuesday as they began debating whether Inamed has provided enough proof that its products are reasonably safe enough to sell.

Also troubling, when gel implants break, they seldom cause pain or other immediate symptoms, so the woman doesn't know to seek medical care. Inamed is proposing that women undergo MRI scans every year or two to check if their implants have broken. The advisers agreed that MRI exams are necessary, but they couldn't say how often women should get the exams, which cost hundreds of dollars, or how soon after implantation they should start.

The FDA isn't bound by its advisers' recommendations; indeed, it rejected a 2003 vote from this panel that narrowly supported the implants' return. FDA officials haven't indicated how quickly they will decide this time around.

On Wednesday, the panel will consider Mentor Corp.'s competing silicone implants.

Inamed shares rose 84 cents, or 1.3 percent, to $66.49 in late trading on the Nasdaq Stock Market while Mentor shares fell 14 cents to $34.42 on the New York Stock Exchange.