Breast implant maker Sientra has halted U.S. sales of breast implants made by contract manufacturer Silimed, following suspension of sales in Brazil, the U.K., and other countries.
Sientra, based in Santa Barbara, California, posted a letter to surgeons on its website, asking that they stop implanting the devices until further notice, Qmed reports. A German audit of Silimed’s Brazilian factory found some manufacturing surfaces contaminated by unidentified particles.
The company says it has been in “ongoing discussions” with the U.S. Food and Drug Administration (FDA) about this matter and “out of an abundance of caution,” Sientra is recommending that surgeons temporarily discontinue implanting all Sientra devices manufactured by Silimed. Sientra’s 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.
Sientra did not ask surgeons to remove any patients’ implants, and the company said no injuries have been reported. Zeini said the company is conducting its own review, according to Qmed.
Silimed is the biggest maker of silicone implants in South America and claims to be the third largest implant manufacturer internationally, Qmed reports. On its web site, Silimed insists its products are safe, despite the voluntary halt in product sales. Silimed makes 5,000 types of implants used in procedures ranging from general surgery to bariatric surgery. The company had been the first South American firm to claim that its silicone breast implants had been approved by FDA.
According to Qmed, this is the biggest breast implant scare since the 2010 incident involving Poly Implant Prothèse (PIP), which resulted in a prison sentence for the company’s CEO, the closing of PIP, and stricter implant regulation in the European Union.
Switzerland, Ireland, Australia, and New Zealand have also suspended sales of products made by Silimed.