It’s been years since we first heard about the “gummy bear implant” being used in breast augmentation around the world. Finally, Allergan has received approval from the U.S. Food and Drug Administration (FDA) to market the new breast implant for cosmetic procedures.
The FDA’s approval of The Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant a.k.a. the gummy bear implant, is based on seven years of data from 941 different women. It is now one of four FDA-approved silicone gel-filled breast implants available in the U.S.
“The FDA approval of Natrelle 410 shaped gel implants provides an important new alternative to traditional round implants for women considering breast augmentation, reconstruction or revision surgery,” says David E.I. Pyott, Allergan’s chairman of the board, president and chief executive officer. “The Natrelle 410 is the most selected shaped gel implant in markets where the product is already available, such as Europe and Canada.”
So how does this implant differ from others? Shaped to mimic the slope of the breast, the natural-looking gel implant is filled with a cohesive silicone gel that is not only soft to the touch, but also allows the implant to hold its shape over time with no risk of deflating or leaking.
“For many patients, round silicone and saline breast implants are good options. For others, they may not provide the aesthetic outcome they desire,” says Dr. Scott L. Spear, chairman of the department of plastic surgery at Georgetown University School of Medicine. “As well, patients may have minimal breast tissue remaining after the removal of a tumor or have lost breast volume over the years, so the option of a shaped breast implant designed with an anatomical shape that lasts over time is an important one as it may help these patients obtain the aesthetic look they are seeking.”
At this time, there is no information on the comparison of this implant to the other approved silicone gel-filled breast implants on the market from Allergan, Mentor, and Sientra.
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