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FDA moves toward silicone implant OK

Conditional approval given more than a decade after moratorium

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Food and Drug Administration (FDA)
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(CNN) -- Silicone gel-filled breast implants moved a step closer to the U.S. market after the Food and Drug Administration said Thursday it has issued an "approvable" letter to Mentor Corp. for its implants.

Though regulations prohibit the government from discussing the contents of the letter, it is one of several steps in the FDA review process for new products.

At its meeting in April, the General and Plastic Surgery Devices Advisory Committee voted 7-2 that Mentor's application was "approvable with conditions."

"We are very encouraged by this communication from the FDA, and view this letter as a positive sign for women and their surgeons that another option will soon be available," said Joshua H. Levine, president and chief executive officer of Mentor Corporation.

If approved by the FDA, he said, Mentor's implants "will be a significant additional option for these women. Mentor is committed to making these important products available to women and will continue working with the FDA to address the approvable conditions."

The FDA asked for a voluntary moratorium on the sale of silicone gel breast implants in 1992, after a number of anecdotal reports linking ruptured implants with immune system disorders. Those reports have not been substantiated by controlled clinical trials.

Critics claim silicone often leaks from the gel-filled devices, causing cancer and neurological diseases.

As a result, more than 90 percent of the U.S. market now uses saline-filled implants.

Female senators concerned

A bipartisan group of nine female senators -- including California Democrat Dianne Feinstein and Maine Republican Olympia Snowe -- on Thursday sent a letter to FDA Commissioner Lester Crawford urging the agency to consider women's health safety in its final decision on the implants.

The senators said the in letter they are "extremely concerned that the risks of this device are far disproportionate to the benefit that a woman undergoing breast augmentation would realize."

"Silicone implants, while providing a prosthetic with more natural characteristics, bear greater risks than saline implants," the letter said, citing interference with mammographies and the inability to detect ruptures without MRI scans.

The senators noted "limitations" with safety data provided by Mentor. They also cited a 2000 FDA study that found a failure rate of 55 percent in women who had silicone implants for an average of 16 years.

"FDA does not know the true failure rate for Mentor's device, nor the implications of implant rupture," the letter said.

The senators rejected the idea that warnings issued to women who receive the implants would address safety concerns, saying that "such conditions have proven to be ineffective or unenforceable."

Noting that saline implants have remained available for women who have undergone mastectomies, the senators encouraged the FDA to continue examining other promising new prosthetics for breast cancer patients.

The other senators sending the letter were New York Democrat Hillary Clinton, Texas Republican Kay Bailey Hutchison, California Democrat Barbara Boxer, Louisiana Democrat Mary Landrieu, Michigan Democrat Debbie Stabenow, Arkansas Democrat Blanche Lincoln and Maryland Democrat Barbara Mikulski.

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