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FDA: Silicone implants mostly safe

WASHINGTON -- Federal health officials say the latest data on silicone breast implants show they are relatively safe, despite frequent complications that lead about one in five women to have the implants removed within 10 years.

A Food and Drug Administration report issued yesterday is the agency's first safety assessment of the implants since they returned to the market in 2006, after a 14-year ban when only saline-filled implants were widely available.

The FDA pulled silicone implants off the market in 1992, saying manufacturers had not provided medical data showing their safety and effectiveness. There were worries then about a connection to some diseases, including cancer and lupus. But the agency returned the implants to the market five years ago after most studies failed to find a link between silicone breast implants and those diseases.

The approval came with conditions, including a requirement that the companies Allergan Inc. and Johnson & Johnson's mentor unit complete studies on women who have received the implants.

But industry critics point out that most of the studies are incomplete, and many women have already dropped out. -- AP

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