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Sientra Sends Letter To Plastic Surgeons Regarding Silimed-Manufactured Products

The following excerpt is from the company's SEC filing.

SANTA BARBARA, Calif., October 9, 2015

Sientra, Inc. (NASDAQ:SIEN), a medical aesthetics company, today announced that it has sent a letter to plastic surgeons regarding products manufactured by Silimed, one of Sientras contract manufacturers.

Among other things, the letter updates plastic surgeons on actions Sientra is taking:

Sientra has been in ongoing discussions with the United States Food and Drug Administration (FDA) regarding Brazilian regulatory inquiries into Silimed Products, and is conducting its own review of the matter.

Out of an abundance of caution, Sientra is volunt arily placing on temporary hold the sale in the United States of all Sientra devices manufactured by Silimed and is also recommending that plastic surgeons discontinue implanting these devices until further notice.

Brazilian and other regulatory agencies have reiterated that no reports of adverse events and no risks to patient health have been identified in connection with implanting Silimed-manufactured products, and, accordingly, there is no need to explant or adopt any specific procedure or action for those patients who have received them.

The full text of the letter is below:

Dear Valued Plastic Surgeon,

As a valued partner to Sientra, we want to ensure we are communicating with you in a timely fashion about the latest information regarding our products.

As we previously announced, we learned that Brazilian regulatory agencies have temporarily suspended the manufacturing of all medical devices made by Silimed, including products manufactured for Sientra, as they continue to review technical compliance issues related to Good Manufacturing Practices (GMP) at Silimeds manufacturing...


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