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www.fdanews.com/articles/173550-sientra-puts-temporary-hold-on-us-sales-of-silimed-devices

Sientra Puts Temporary Hold on U.S. Sales of Silimed Devices

October 12, 2015

Sientra placed a temporary hold on all U.S. sales of devices made by one of its contract manufacturers, Brazil-based Silimed, pending an FDA review of Silimed’s manufacturing operations.

The Santa Barbara devicemaker, which took the step voluntarily, is also urging plastic to surgeons stop implanting the devices until the review is completed. Sientra says it is conducting its own review of Silimed as well.

Brazilian and British authorities previously suspended sales of Silimed implants after an audit of the company’s facility revealed that sterile products may have been contaminated. No adverse events related to the problem have been reported, Sientra says. — Michael Cipriano