Sientra is planning to return all of its medical devices — including breast implant products — to the U.S. market starting March 1.
The move follows completion of independent, third-party testing and analyses of its products in the U.S.
In a letter to physicians, the company says the testing shows its products are safe and do not represent a risk to patients in the U.S.
Under worst-case testing conditions, the products exhibit a high safety margin compared with numerous U.S. and international standards, the company says.
The company voluntarily removed its products from the U.S. market in October 2015.
That move came after the UK’s Medicines and Healthcare products Regulatory Agency, along with other European health regulators, suspended CE certification for all products made by Brazilian implant maker Silimed — which is used by Sientra as a contract manufacturer — after particle contamination was discovered during a facility inspection.
Margaret Kaczor and Scott Schaper of William Blair say that there are uncertainties for the company — including physician uptake and a lack of a reliable manufacturing facility. However, they believe Sientra will move forward.
“Sientra has an exclusive manufacturing contract with Silimed, which is due to expire in April 2017; given the time frame to qualify a new manufacturing facility (roughly 18 months), we would not be surprised if the company has been working on these alternative plans for some time,” Kaczor and Schaper write.
Stay up to date on regulatory stories like this one by subscribing to the The GMP Letter. For 30 years, devicemakers have relied on The GMP Letter for the latest on the FDA’s interpretation and enforcement of cGMPs and the Quality Systems Regulation.