You can now read 10 articles a month for free. Read as much as you want anywhere and anytime for just 99¢.

FDA clears 3d brand of silicone breast implant

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.

Continue reading below

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.

Loading comments...

You have reached the limit of 10 free articles in a month

Stay informed with unlimited access to Boston’s trusted news source.

  • High-quality journalism from the region’s largest newsroom
  • Convenient access across all of your devices
  • Today’s Headlines daily newsletter
  • Subscriber-only access to exclusive offers, events, contests, eBooks, and more
  • Less than 25¢ a week