Brazilian regulator Anvisa and the U.K.’s Medicines & Healthcare Products Regulatory Agency had already suspended sales of implants made by Silimed, which is Sientra’s sole supplier, after contamination was detected during an audit of the company’s manufacturing practices. SIEN shares plummeted some -53% Sept. 24 in reaction to the British regulator’s move and hit a 52-week low of $8.01 apiece on the Anvisa ban.
Santa Barbara, Calif.-based Sientra said Oct. 9 that it’s in talks with the FDA about the Silimed problem, emphasizing that there have been no reports of injuries connected with the implants, and put the voluntary hold in place “out of an abundance of caution.”
“We are voluntarily recommending that you temporarily discontinue implanting all Sientra devices manufactured by Silimed. We are also voluntarily placing on temporary hold, the sale in the United States of all Sientra devices manufactured by Silimed, and we ask that you set aside all such devices in a secure location and not use them until further notice,” founder & CEO Hani Zeini wrote in a letter to surgeons last week.
“Let me emphasize that we are taking these steps as a precautionary measure. It is important to note that no reports of adverse events and no risks to patient health have been identified in connection with implanting these Silimed-manufactured products. Furthermore, neither Brazilian regulatory agencies nor any other regulatory authority has found that there is a need to explant these devices or adopt any specific procedure or action for patients who have received them. This finding has been reiterated by the foreign regulators reviewing this matter in their public announcements,” Zeini wrote.
SIEN shares closed down -2.8% Oct. 9 at $7.01 each. The stock is off its Sept. 24 price of $20.58 by nearly 66%.
Sientra raised more than $80 million in an initial public offering in November 2014.
Material from Reuters was used in this report.