The Food and Drug Administration today cleared Sientra Inc.'s silicone breast implants for use in the U.S., adding another competitor to versions of the product already offered by Allergan Inc. (AGN) and Johnson & Johnson (JNJ) unit Mentor Worldwide LLC. Sientra will be the third manufacturer of silicone breast implants in America given the current US FDA regulations.
The latest approval comes after the FDA in August said it will allow silicone implants to remain on the U.S. market while manufacturers work to boost enrollment rates in required long-term studies.
The agency has said women receiving silicone-gel breast implants experience frequent complications and sometimes need additional surgery to fix or replace them, but recent studies haven't shown any unexpected or new safety concerns for the existing implants on the market.
The FDA based its Sientra approval on three years of clinical data from 1,788 participants. The latest approval permits breast-augmentation surgery in women at least 22 years old as well as reconstructive procedures for women of any age.
"Data on these and other approved silicone gel-filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness," said William Maisel, deputy director for science at the FDA's Center for Devices and Radiological Health.
The agency will also require that Sientra run post-approval studies judging the long-term safety and effectiveness of the implants as well as the risk of rare diseases among women using them.
Sientra founder and Chief Executive Hani Zeini helped launch the privately held company after an earlier stint at Inamed Corp., the breast-implant maker later acquired by Allergan.
As a plastic surgeon who performs many breast augmentation surgeries, it is exciting to have another brand available on the market to choose from! Competition is a good thing in the world of medical devices and I am glad that women will have a third option when it comes to silicone gel breast implants.