The FDA this week granted a pre-market approval supplement to Sientra (NSDQ:SIEN) for its Opus line of silicone breast implants.
The implants are made in Wisconsin by Lubrizol LifeSciences subsidiary Vesta, which inked a contract manufacturing deal with Sientra back in August 2016.
Sales of Sientra’s silicone breast implants ground to a halt in the autumn of 2015, when Brazilian authorities suspended production at Silimed, its supplier there, and the U.K.’s Medicines & Healthcare Products Regulatory Agency halted sales. The products were back on the market in the U.S. by March 2016, after Santa Barbara, Calif.-based Sientra tapped a new CEO, Jeffrey Nugent, to oversee the recovery process.