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Officials Say More Information Is Needed on Safety of the Devices

FDA Nixes Silicone Breast Implants, for Now

Silicone Breast Implants and the FDA continued...

These concerns caused the FDA to ban the sale of silicone breast implants in 1992 except for use in clinical trials. The ban also prompted a string of lawsuits against implant manufacturers from women who said they suffered health problems or disfiguration as a result of their silicone breast implants.

In December 2002, Inamed filed a product marketing application with the FDA for a silicone implant based on the results of their own study of 1,000 women with the implants who were followed for at least three years, as well as other research published since the ban was enacted.

On Oct. 15, 2003, an FDA advisory panel voted 9-6 in favor of recommending reapproval of the sale of silicone implants under certain conditions, such as warning patients of the risks associated with silicone breast implants, yearly testing for leaks, and continued monitoring of implant recipients.

But in a highly unusual move, panel chairman Thomas Whalen, MD, sent a letter to the FDA and members of Congress a month after the meeting in which he implored the agency not to approve the silicone gel-filled implants, citing serious concerns about the long-term safety of the devices.

"As the dust has settled on the panel, and I've reflected more and more on the information that was revealed during the panel session, I've become increasingly uncomfortable with what I clearly feel has been the lack of demonstration of long-term safety of the devices," said Whalen in a November 2003 interview with WebMD. "I most clearly and unequivocally would have voted against it."

As chairman of the FDA advisory committee on general and plastic surgery devices, Whalen is not allowed to vote in panel decisions unless there is a tie.

Booming Market for Breast Implants

Meanwhile, saline-filled breast implants are already approved for use in breast augmentation and reconstruction surgery. These implants contain a saltwater solution similar to that used in IV fluids.

Although saline implants are also likely to leak or rupture over time, research shows that the risks posed by leakage are less serious because the body readily absorbs the saline solution.

Despite some uncertainty about breast implants, the demand for them is clearly increasing.

According to the American Society of Plastic Surgeons, more than 225,000 women received breast implants for cosmetic reasons in 2002, a 593% increase since 1992. Breast augmentation was also among the top five cosmetic plastic surgery procedures in 2002.

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