FDA Approves the “Gummy Bear” Breast Implant
February 28, 2013 - By Dr. Jules Feledy
If you keep yourself abreast of the world of plastic surgery, the term “gummy bear” should hold two meanings for you: the delicious, ursine candies, and 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 plastic surgery community.
Natrelle 410 silicone gel breast implants are now cleared for use
Well, it’s now 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 breast 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 the offices of Dr. Jules Feledy and book a consultation.