Last week, the FDA approved the use of the silicone "gummy bear" implant. The 410 implant by Allergan is an anatomically-shaped, textured, silicone cohesive gel implant that is much firmer than the previous silicone gel implants. This new generation of implants have been shown in previous to have decreased complication rates, such as rupture and capsular contracture.
During the time of investigation, in addition to breast augmentation, they have been used in breast reconstruction with some excellent results. The "tear-drop" shape of the implant may potentially give a more aesthetically-pleasing and more natural appearance of the breast. There is a potential for rotation of the implant within the pocket, which has been shown to significantly decrease with experience with their use. Surgeons were chosen to participate in the investigational trial in order to use these implants during their several years of trial. We have used, and have been using such implants as the Allergan 410, Mentor CPG, and Sientra implants for several years during training as well as in practice, with excellent results. We have significant experience with all of these implants.
We hope that the approval of these implants will significantly make a dramatic difference for the breast reconstruction patients in the future with the development of these excellent implants.
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