Sientra breast implants to return to US market

Sientra recently announced in a press release that its breast implant products and other medical devices will return to the U.S. market beginning March 1.

“We are extremely pleased to return our products to the U.S. market, where we can once again provide choice to board-certified plastic surgeons,” Jeffrey Nugent, chairman and CEO of Sientra, stated in the release. “Our decision to place the voluntary hold on Sientra products was difficult, but we felt it was the responsible action to take at the time amid speculation to ensure that Sientra products remain a safe choice for our customers and their patients.”

In October, Sientra had placed a temporary hold on all Sientra devices manufactured by Silimed, after Brazilian regulatory agencies temporarily suspended the manufacturing of all medical devices made by Silimed, according to a separate press release.

Sientra has completed an extensive independent, third-party testing and analyses of its products in the U.S., according to the release. The products exhibited a high safety margin compared to U.S. and internationals standards for medical device and materials safety, using worst-case testing conditions.

“The conclusive results of our testing indicate no anticipated significant safety concerns with the use of Sientra products, including our breast implants, consistent with their approval since 2012,” according to the release.

“Following the results of the independent, third-party testing, we are more confident than ever of the safety of our devices, specifically our breast implant products, which are further supported by our 9-year clinical study data to be published in April 0f 2016,” Nugent stated in the release.

A letter has been sent to surgeons to inform them of Seintra’s market re-entry plans, according to the release.

Reference: www.sientra.com