Sientra breast implants will be returning to U.S. doctors’ offices on March 1, almost five months after the Goleta company pulled the products off the market.
Sientra released the news Feb. 8 in a filing with the Securities and Exchange Commission just before markets opened at 6:26 a.m. The company pulled its products from the U.S. market on Oct. 9 after European regulators suspended sales of products made by Sientra’s Brazilian manufacturer, Silimed, on Sept. 23.
Regulators alleged implants made by Silimed and sold in Europe were contaminated by microscopic particles of silica and cotton in September. German newspaper Badische Zeitung reported in December that the particles were just 20 nanometers in size. A nanometer is a millionth of a millimeter. A human hair has a diameter of 80,000 to 100,000 nanometers. Surgeons told the Business Times that such extremely small particles would not threaten patients.
Sientra has maintained all along its products, which are sold in the U.S. and not Europe, are safe and pose no risk to patient safety. Additionally, the Food and Drug Administration never conducted a formal review of Sientra products because, during prior reviews, the FDA deemed Sientra products safe.
Plastic surgeons interviewed by the Business Times vouch for their safety.
Sientra CEO Jeffrey Nugent said in a news release that the company conducted extensive testing to determine that its breast implants continue to pose no risk to patient safety.
The decision to place the voluntary hold on Sientra products was difficult, Nugent said. “But we felt it was the responsible action to take at the time amid the speculation, to ensure that Sientra products remain a safe choice for our customers and their patients.”
Nugent also said safety results from a nine-year clinical study will be released in April. Sientra did not say when production of Sientra breast implants might resume. The company has about a year’s supply of implants already manufactured. Nugent said in January the company was exploring its options and possibly looking for a new manufacturer.
Shares of Sientra stock spiked on the news, opening at $10.40 after closing Feb. 5 at $8.60 per share. The stock peaked at $10.45 and traded for $9.79 as of 9:49 a.m.
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