New Generation Implant Cannot Leak, Provides More Natural Look and Feel
Many women considering breast augmentation or reconstruction procedures shy away due to fears that their implants may rupture and leak. Others worry that the implants will not look or feel natural, or might quickly deform to give a ripple appearance.
This week the U.S. Food and Drug Administration (FDA) approved a new 5th generation implant, the Natrelle 410, which eliminates both of these concerns. “We all think of an implant as a fluid-filled pouch,” says Dr. Allen Gabriel, one of our nation’s premiere breast augmentation specialists. “The Natrelle 410 is not a liquid in a pouch. It’s a supple, soft, natural feeling solid implant. Because it is not a fluid, it can’t leak. And due to its supple, yet firm composition, it can be contoured to provide the most natural looking appearance possible. This product is revolutionary, and it will be a game changer in breast reconstruction and augmentation.”
The Natrelle 410 has been tested extensively by the FDA in clinical trials, with outstanding results and excellent patient satisfaction. The implant, manufactured by Allergan, Inc., is an anatomically shaped silicone-gel product intended for both increasing breast size and for rebuilding breast tissue.
The FDA based its approval on the positive results achieved in a 7-year study of nearly 1,000 women. “The data we reviewed showed a reasonable assurance of safety and effectiveness,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health.
Dr. Gabriel trained under surgeon Dr. G. Patrick Maxwell, who was involved in the development of this implant. Dr. Gabriel adds that, while the Natrelle 410 is new to the U.S., it has a proven track record of safety. “This implant has been available internationally for nearly two decades, and has proven itself to be a wonderful product. I am very excited to finally have the opportunity to offer my patients this step forward in breast reconstruction and augmentation.”