9 de octubre de 2015 / 22:40 / hace 2 años

Sientra suspends sales of medical implants made by Brazilian contract partner

Oct 9 (Reuters) - Breast implant maker Sientra Inc said it has placed a temporary hold on sales of medical implants made by a Brazilian contract manufacturer, sending its shares down 11 percent in extended trading.

Sientra also said it recommends that plastic surgeons temporarily discontinue implanting all Sientra devices made by the Brazilian contractor, Silimed, until further notice.

Sientra said its decision followed discussions with the U.S. Food and Drug Administration regarding Brazilian regulatory inquiries into products manufactured by Silimed. Sientra said it is also conducting its own review.

The Brazilian health regulator on Monday suspended the manufacturing of all medical devices made by Silimed. Sientra said Brazilian regulators have been reviewing technical compliance issues at Silimed’s manufacturing facility.

Sientra, based in Santa Barbara, California, said Brazilian and other regulators have not had any reports of adverse events or found any risks to patient health from the devices.

Sientra shares have fallen about 32 percent since Monday. The shares closed at $7.01 on the Nasdaq on Friday. (Reporting by Rosmi Shaji in Bengaluru; Editing by Leslie Adler)

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