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Sientra becomes third US company to win FDA approval for silicone-gel based breast implants
WASHINGTON (AP) ' The Food and Drug Administration has approved a new silicone-gel breast implant from Sientra, the third company to market the controversial products in the U.S.
The California plastic surgery company won approval to market the implants for breast enhancement and reconstruction in women at least 22 years old.
The FDA has wrestled with the safety of the silicone-gel implants for over 20 years. In 1992, the agency banned the products amid fears they might cause cancer, lupus and other diseases. But when research ruled out most of the disease concern, regulators returned the implants to the market in 2006.
Since then the FDA has required manufacturers Allergan and Johnson & Johnson to track the health and complications of women who receive the implants. Sientra is subject to the same requirements.