All medical devices made by Sientra, a medical aesthetics company, are returning to market after temporary suspension
The company temporarily suspended all of its devices manufactured by Silimed after Brazilian regulatory agencies suspended the manufacturing of all medical devices made by Silimed.
Tomorrow, 1 March 2016, all of Sientra’s medical devices, including Sientra breast implant products, will return to the US market.
Sientra is taking this action subsequent to the completion of extensive independent, third-party testing and analyses of its products in the US.
Under worst-case testing conditions, the products exhibit a high safety margin compared to numerous US and international standards for medical device and materials safety, according to the company.
Sientra said that the conclusive results of the testing indicated no anticipated significant safety concerns with the use of its products, including breast implants, consistent with their approval status since 2012.
Jeffrey Nugent, chairman and chief executive officer of Sientra, said: "We are extremely pleased to return our products to the US 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."
Sientra has also sent a letter to its surgeons informing them of the Company's market re-entry plans. A copy of that letter can be found in the Investor Relations section of Sientra's web site or by clicking here.