FDA Lifts 14-Year Ban on Silicone-Gel Breast Implants - Cleveland 19 News Cleveland, OH

FDA Lifts 14-Year Ban on Silicone-Gel Breast Implants

AP AP

WASHINGTON (AP) - The government ended a 14-year virtual ban on silicone-gel breast implants Friday despite lingering safety concerns, making the devices available to tens of thousands of women who have clamored for them.

The Food and Drug Administration approved the silicone-gel implants made by Inamed Corp. - now part of Allergan Inc., the company said.

A second California company, Mentor Corp., also was seeking approval.

FDA planned a teleconference later Friday to announce a new product approval.

The action opens the implants to much wider use by women seeking to reconstruct or augment their breasts. Since 1992, the silicone implants had been available only as part of research studies.

Silicone-gel breast implants first went on the market in 1962, before the FDA required proof that all medical devices be safe and effective. Thirty years later, they were banned amid concerns about their safety.

At the time, there were worries about a possible connection to a variety of diseases, including cancer and lupus. Alarming cases of ruptures added to the concern.

Since then, most studies have failed to find a link between silicone breast implants and disease.

The rupture issue persists: The implants do not last a lifetime, and eventually they must be removed or replaced, according to the FDA. A 2000 Institute of Medicine report found rupture rates as high as 77 percent.

Women whose silicone implants ruptured have reported years of pain, swelling, numbness and other symptoms that they blame on the devices. Leaked silicone gel can migrate throughout the body, forming lumps. Implants also can cause infection and form hard, painful scar tissue that can distort the shape of a breast.

Some researchers also worry that the platinum used to manufacture the implants can seep into the body and cause harm. The FDA says there is no evidence of that.

Proponents say silicone-gel implants look and feel more natural than do those filled with saline, or salt water. Those implants are sold without restrictions.

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