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FDA Panel Says No To Silicone

This is an undated Guinness World Records handout photo made available Sept. 16, 2010 of Swallow, right, an 11-year-old cow from Yorkshire posing next to Freddie the bull. (AP Photo/Ranald MacKechnie/Guinness World Records, Ho)
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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.