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FDA approves new silicone breast implant from J&J
Friday - 6/14/2013, 6:30pm EDT
WASHINGTON (AP) -- The Food and Drug Administration has approved a next-generation silicone breast implant from Johnson & Johnson unit Mentor.
The company's MemoryShape breast implant uses a cross-linking gel design that the FDA says is firmer than previous implants.
FDA regulators approved the new implant for breast enhancement and reconstruction in women at least 22 years old.
Silicone gel implants have made a comeback recently after safety concerns kept them off the market for nearly 25 years.
The FDA banned sales of silicone breast implants in 1992, saying manufacturers had not provided enough medical data showing their safety and effectiveness. At the time, there were worries about a connection to a variety of diseases, including cancer and lupus. Alarming cases of ruptures added to the concern.
But in 2006 the agency returned the implants to the market after most studies failed to find a link between silicone breast implants and disease.
Since then the FDA has required manufacturers to track the health and complications of women who receive the implants.
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