Sientra resumes U.S. sales of breast implants after Brazil manufacturing fallout

Breast implants--Courtesy of Sientra

Sientra is turning over a new leaf. The company will start selling its breast implants again in the U.S. months after issues cropped up at its Brazilian contract manufacturer's plant, prompting it to suspend sales of its devices.

Sientra will begin selling the implants on March 1, 2016, a win for the company as it tries to recover from a manufacturing fallout. Back in September, Sientra's sole manufacturer, Silimed, had its marketing certificate suspended by U.K. and EU regulators after inspectors found technical issues at the company's Brazil facility.

Brazilian regulators then shut down Silimed's factory in the country for precautionary reasons, sending Sientra's shares into a downward spiral. In October, Sientra temporarily put a hold on sales of its breast implants while it sorted out the problems.

"Our decision to place the voluntary hold on Sientra products was difficult, 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," new CEO Jeffrey Nugent said in a statement. The company will report out 9-year clinical study data of its products in April, Nugent said.

Sientra CEO Jeffrey Nugent

Sientra also is notifying doctors about its plans to re-enter the market. In a letter addressed to a "valued board-certified plastic surgeons," Nugent talked about the company's steps to ensure its products' safety.

"Over the next few weeks we are turning our attention to restarting our commercial activities. This process will take place over the coming weeks and months, during which time we will be laser focused on a controlled, predictable approach to resuming our commercial operations," Nugent said. "We owe it to our loyal customer base to ensure that our re-entry occurs with the same high-level of Sientra customer service for which we have become known."

Nugent will have his hands full in the months ahead. The CEO came on board in November to help clean up shop and boost numbers. Sientra lost almost 85% of its value after the manufacturing issues surfaced last year.

- read the statement
- here's the company's letter (PDF)
- get the Reuters story

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