WASHINGTON - 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 United States.
Santa Barbara, Calif.-based Sientra won approval to market its implants for breast enhancement and reconstruction in women at least 22 years old. The company’s implants join those sold by Allergan Inc. and Johnson & Johnson’s Mentor unit.
The FDA has wrestled with the safety of silicone-gel implants for more than 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.
Since then the FDA has required manufacturers to track the health and complications of women who receive the implants. The most recent data from Allergan and J&J confirm that the devices are prone to rupture.
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 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.