Breast Implant Maker Halts U.S. Sales of Implants Due to Possible Contamination in Manufacturing Facility

The breast implant maker Sientra has halted U.S. sales of implants manufactured under contract manufacturer in Brazil, following suspension of sales of those implants in Brazil and other countries.

The company, Sientra, based in Santa Barbara, California, posted a letter to surgeons on its web site, asking them to stop implanting devices made by contractor Silimed until further notice, Qmed reports. A German inspection of Silimed’s Brazilian factory found some manufacturing surfaces contaminated by unidentified particles.

In the letter, Sientra says it has been in “ongoing discussions” with the U.S. Food and Drug Administration (FDA) about this matter and is acting “out of an abundance of caution” in recommending that surgeons temporarily discontinue implanting all Sientra devices manufactured by Silimed. CEO Hani Zeini wrote, “We are also voluntarily placing on temporary hold, the sale in the United States of all Sientra devices manufactured by Silimed, and we ask that you set aside all such devices in a secure location and not use them until further notice,” Qmed reports. Switzerland, Ireland, Australia, and New Zealand have also suspended sales of products made by Silimed.

Sientra did not ask surgeons to remove any breast implants already inserted, and the company said it has no reports of injuries in patients who have the Silimed implants. Zeini said the company is conducting its own review, according to Qmed.

Silimed is South America’s largest maker of silicone implants and the company says it is the third largest implant manufacturer internationally. On its web site, Silimed insists its products are safe, despite the halt in product sales, Qmed reports. Silimed makes 5,000 types of implants used in a variety of surgical procedures, from general surgery to bariatric surgery. The company had claimed to be the first South American firm to have its silicone breast implants approved by FDA.

Qmed describes this as the biggest breast implant scare since an incident in 2010 involving Poly Implant Prothèse (PIP). PIP’s CEO was sent to prison, the company closed, and the European Union adopted stricter regulations for implants.

 

from Parker Waichman http://www.yourlawyer.com/blog/breast-implant-maker-halts-u-s-sales-of-implants-due-to-possible-contamination-in-manufacturing-facility/