Sientra CEO Hani Zeini sent another letter to plastic surgeons to reassure them that its products are safe.
Sientra, a Goleta-based breast implant manufacturer, saw shares drop sharply over the past few months from a high of $23.75 on July 23. In recent weeks the stock fell from $20.58 on Sept. 23 to a close of just $7.01 Oct. 9 after regulators found contaminated products at the factory of its contract manufacturer.
On Sept. 23, the United Kingdom Medicines and Healthcare Products Regulatory Agency announced that it had suspended sales of implants produced by Brazilian implant manufacturer Silimed. The company is Sientra’s contract manufacturer and only supplier of implants.
The British regulators said that during a recent inspection, breast, pectoral and other implants were “contaminated with particles” but they had identified no health risks yet for the suspended products.
Sientra filed the letter on Oct. 9 with the Securities and Exchange Commission and said the U.S. Food and Drug Administration is conducting its own review of the matter.
In the letter to plastic surgeons, Zeini said Sientra is voluntarily suspending sales of all Sientra devices manufactured by Silimed and is recommending that plastic surgeons stop implanting the devices.
“Out of an abundance of caution, we are voluntarily recommending that you temporarily discontinue implanting all Sientra devices manufactured by Silimed,” Zeini said in the letter. “No reports of adverse events and no risks to patient health have been identified in connection with implanting these Silimed manufactured products.”
Sientra indicated in its most recent quarterly filing that any disruption in supplies from Silimed could result in significant and prolonged financial losses for the company. Now, that nightmare scenario is unfolding.
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