FDA Approves New Silicone Gel Implant!



The Food and Drug Administration reported Wednesday that it approved a newer version of breast implant from Allergan for women 22 years and older.

The FDA said the Natrelle 410 implant contains silicone gel that is firmer than Allergan’s older Natrelle breast implant products.  However, Allergan’s studies did not compare the safety of the new implant with that of older implants.

Safety of silicone-gel breast implants is something the FDA has wrestled with for more than 20 years. In 1992, the agency banned the implants amid fears they could cause cancer, lupus and other illnesses. But when further research concluded that most of these disease concerns were unwarranted, the review committee  reconsidered, and in 2006, allowed the implants back on the market.

Since then the FDA has required manufacturers to track any complications experienced by women who receive the implants. The most recent data from Allergan and J&J, both silicone breast implant companies, confirm that the implants can rupture and mayneed to be replaced.

According to the press release  the  FDA said the Natrelle 410 was studied in 941 women over a seven-year period.

“The data we reviewed showed a reasonable assurance of safety and effectiveness,” said Dr. Jeffrey Shuren, the FDA’s medical device director. “We will be looking at the results from post-approval studies that will focus on their long-term safety and effectiveness.”

Irvine, Calif.-based Allergan sells breast implants, Botox anti-wrinkle injections and other cosmetic treatments.

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