Sientra Surges After Company Confirms Its Products Will Return To U.S. Market In March

Shares of Sientra Inc SIEN surged higher by more than 12 percent on Monday after the company confirmed in a press release that all of its products will return to the U.S. market as soon as March 1, 2016.

Sientra's announcement follows the completion of an independent, third-party testing and analyses of its products in the U.S. The company's primary products are silicone gel breast implants.

Sientra noted that under the worst-case testing conditions, its products "exhibit a high safety margin compared to numerous U.S. and international standards for medical device and materials safety." The company also added that the results of the testing indicate "no anticipated significant safety concerns."

Jeffrey Nugent, Chairman and Chief Executive Officer of Sientra, said, "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. 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 the speculation, to ensure that Sientra products remain a safe choice for our customers and their patients. Following the results of independent, third-party testing, we are more confident than ever in the safety of our devices, and specifically our breast implant products, which are further supported by our 9-year clinical study data to be published in April of 2016. In terms of the confirmation of our manufacturing supply initiatives, we are confident that our resupply process will be in place in sufficient time to assure our customers of uninterrupted supply."