Dr. Larry Nichter of the Pacific Center for Plastic Surgery would like to make prospective breast augmentation patients aware that the FDA has approved a new silicone gel-filled breast implant made bySientra, Inc. for use in the United States.
The implants will be available for women at least 22 years old seeking augmentation surgery, and women of any age seeking breast reconstruction surgery.
Silicone gel-filled breast implants are medical devices implanted under the breast tissue or under the chest muscle for breast augmentation or reconstruction. These implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells.
This approval introduces a third company into the U.S. breast implant market, which previously consisted only of Allergan and Mentor.
The deputy director for for science at the FDA’s Center for Devices and Radiological Health, Dr. William Maisel, commented that although silicone gel-filled breast implants have demonstrated consistent safety, “It’s important to remember that breast implants are not lifetime devices. Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.”
The approval of these new implants follows a 3-year study involving clinical trials of the implants on 1,788 women.
As a condition of the approval, Sientra will carry out five- and ten-year studies into the long-term health effects of their implants.
Source: FDA – FDA approves new silicone gel-filled breast implant