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.
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.
Schedule your consultation today
The surgeons at Belmont Plastic Surgery are here to help you take the next step on your aesthetic journey. Whether you want to restore what has been lost or improve upon what you already have, our surgeons will help you make the best possible choices for your care and deliver excellent results. Every day is an opportunity to live a more beautiful life. Seize your opportunity today with a consultation at Belmont Plastic Surgery.
5530 Wisconsin Ave, Suite 818, Chevy Chase MD 20815