The Food and Drug Administration has approved a new silicone-gel breast implant from Sientra, making it the third company to market the controversial products in the U.S.
The California plastic surgery company won approval to market the implants for breast enhancement and reconstruction in women at least 22 years old.
The FDA has wrestled with the safety of the silicone-gel implants for over 20 years. In 1992, the agency banned the products amid fears they might cause cancer, lupus and other diseases. But when research ruled out most of the disease concern, regulators returned the implants to the market in 2006.
More than one in five women who get implants for breast enhancement will need to have them replaced within five years, accord to an FDA analysis of company data released last summer.
Despite that relatively high failure rate, FDA regulators concluded that the silicone-gel implants are basically safe as long as women understand they come with complications. Similar problems are connected with saline-filled versions of breast implants, which are less popular.
A breast implant is a medical prosthesis used to augment, reconstruct, or create the physical form of breasts.
Applications include correcting the size, form, and feel of a woman’s breasts in post–mastectomy breast reconstruction; for correcting congenital defects and deformities of the chest wall; for aesthetic breast augmentation; and for creating breasts in the male-to-female transsexual patient.