Shares of Sientra hit a new all-time low on Oct. 16 when the stock fell another six cents on the day and closed at $5.77 per share.
For the Goleta-based breast implant manufacturer, it marks another low in a saga that’s starting to turn ugly.
Shares of Sientra initially plummeted from $20.58 per share to $9.70 per share on Sept. 24 after the United Kingdom Medicines and Healthcare Products Regulatory Agency announced that it had suspended sales of implants produced by Sientra’s Brazilian implant manufacturer, Silimed.
At the time British regulators said breast, calf, pectoral and other implants at Silimed’s factory were “contaminated with particles” but posed no risk to patient safety. On Oct. 2, Brazilian regulators announced that they were forcing Silimed to stop production of implants at its factory.
On Oct. 9, Sientra voluntarily suspended sales of its implants in the U.S. The same day the company issued a letter to plastic surgeons which assured patients and surgeons that the products were safe.
“Out of an abundance of caution, we are voluntarily recommending that you temporarily discontinue implanting all Sientra devices manufactured by Silimed,” Sientra CEO Hani Zeini said in the letter on Oct. 9. “No reports of adverse events and no risks to patient health have been identified in connection with implanting these Silimed manufactured products.”
A statement the Food and Drug Administration emailed to the Business Times on Oct. 16 recommended that surgeons stop implanting Silimed and Sientra devices in patients until further notice but the FDA also said the products are safe.
“The FDA is not aware of any adverse patient events related to the current matter under investigation,” the statement said. “We concur with Sientra’s recommendations to take a cautionary approach until more is known and we are actively working with the company and other international regulators to investigate the issue. The FDA is in close communication with the EU and Brazilian authorities as more information is gathered.”
Santa Paula-based Applied Silicone Corp. makes silicone for Silimed implants. Applied Silicone Chief Financial Officer Jack Pitluk told the Business Times on Oct. 15 that Sientra and Silimed are customers but Applied Silicone’s products were not contaminated when they were sold.
A Bloomberg News report on Oct. 16 said the contamination regulators found with the Silimed implants were microscopic particles of silica and cotton on the surface of the implants.
A Sientra spokesman declined to comment for this story.
• Contact Philip Joens at [email protected]