FDA Approves Allergan’s New Breast Implant

Published February 21, 2013 by Dr. Mark Mandell-Brown

Natrelle 410, the “gummy bear implant,” now on the market

Most people probably think of one thing when they heard the words “gummy bear;” the delicious, ursine candies. But there’s another meaning – what are known as “gummy bear breast implants,” the nickname for a type of silicone gel implant that’s been the subject of discussion and interest in the cosmetic surgery community.

Well, now it’s official – the “gummy bear,” or as it’s known officially, the Natrelle 410, has been given the green light by the Food and Drug Administration. Implanted under or over the pectoral muscles, these gel implants offer a firmer feel, due to their enhanced cross-linking silicone bonds.

Allergan, the creator of the Natrelle 410 (as well as patient-favourite Botox), performed clinical studies on 941 women, accruing seven years of data, before the FDA gave them the go-ahead to release the product commercially. Complications included re-operation, asymmetrical appearance, implant removal, and “gel fracture,” a problem unique to Natrelle 410, but overall, the product has passed the FDA’s standards as being reasonably safe and effective.

“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 FDA’s approval comes contingent on Allergan conducting follow-up post-approval studies for up to ten years, but for now, the much talked about gummy bear implants are finally out and ready for patient consumption. If you’re curious about these or any other implants, be sure to contact your cosmetic surgeon and seek a consultation on the matter.

• Photo Credit: in love by .faramarz, on Flickr