After a 14-year virtual ban, silicone-gel breast implants are once again available to women.

Despite lingering safety concerns, the Food and Drug Administration on Friday approved the implants made by Inamed Corp. -- now part of Allergan Inc. -- and Mentor Corp., the two California companies said.

WHAT THE FDA'S DECISION MEANS

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.

HISTORY

They 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.

RUPTURES

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.

POPULARITY GROWING

Breast implants have grown in popularity for augmentation, despite a history of lawsuits. Last year, 291,000 women had their breasts surgically enlarged in the United States, a 37 percent increase since 2000, according to the American Society of Plastic Surgeons.

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