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Published On: Wed, Feb 20th, 2013

FDA approves Natrelle 410 breast implant

The U.S. Food and Drug Administration (FDA) approved Allergan’s  new silicone gel-filled breast implant today, making it the fourth FDA-approved silicone gel-filled breast implant product available in the U.S, according to an FDA news release Feb. 20.

Silicone gel-filled breast implants Image/FDA

Silicone gel-filled breast implants
Image/FDA

The product, the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant, can be used increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.

According to the FDA, the approval is based on seven years of data from 941 women. Most complications and outcomes reflect those found in previous breast implant studies including tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (asymmetry), and infection.

It’s important to remember that breast implants are not lifetime devices. Women should fully understand the risks associated with breast implants before considering augmentation or reconstruction surgery, and they should recognize that long-term monitoring is essential,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

“The data we reviewed showed a reasonable assurance of safety and effectiveness,” said Shuren.

The FDA requires that Allergan conduct a series of post-approval studies to assess long-term safety and effectiveness outcomes and the risks of rare disease.

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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the podcast, Outbreak News Interviews on iTunes, Stitcher and Spotify Robert is politically Independent and a born again Christian Follow @bactiman63

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