FDA Rejects Silicone Gel Breast Implants

Steve Sternberg, The Associated Press: January 9, 2004

Silicone breast implants were dealt a new blow Thursday when the Food and Drug Administration rejected Inamed Corp.’s bid to bring them back on the market a decade after earlier versions were ruled unsafe and banned.

In a rare rejection of its own scientific advisory committee’s recommendation, the FDA notified the California-based company that it must supply more evidence that its silicone implants are safe before the agency approves them for cosmetic breast enhancement.

”There’s additional information that we think is necessary for this product to pass the threshold of what we consider necessary for open marketing,” said Daniel Schultz, the FDA’s director of device evaluation.

Silicone breast implants are now allowed only for reconstruction after breast cancer surgery and in controlled trials for women who want them for cosmetic reasons.

The FDA followed up its decision by releasing a new ”draft guidance” detailing additional tests and procedures the agency will require for approval.

Nick Teti, Inamed’s chief executive, expressed disappointment with the FDA decision but added: ”We’re just now going through the guidance document they sent us. We’ll be starting active discussions (with FDA officials) on Monday to identify what they need and how we can supply it.”

Some women say they prefer silicone-filled breast implants over those made with saline because silicone implants have a more natural feel. Critics worry about the long-term health consequences when implants break and leak. They cite studies linking silicone implants with cancer, immune disorders and crippling fatigue. But a 1999 Institute of Medicine analysis found no proof that silicone implants cause severe health problems.

Nevertheless, experts say researchers haven’t yet determined why silicone implants break, how often they break, and how best to manage women whose implants leak or rupture.

”Even the FDA advisers who recommended approval all agreed that we don’t know the long-term safety (of these devices). It’s terrific that the FDA heard that message,” said Diana Zuckerman, president of the National Center for Policy Research for Women and Families, a Washington-based think tank.

Zuckerman hailed a provision in the FDA guidance document calling for the development of new external performance tests that better mimic conditions within the breast.

The advisory committee voted 9-6 in October to recommend that the devices be approved for cosmetic use. But the committee’s non-voting chairman, Thomas Whalen of Robert Wood Johnson Medical School, New Brunswick, N.J., later expressed his ”angst” about long-term safety in a letter asking FDA officials to reject his own committee’s guidance.

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