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Audit of Major Breast Implant Maker Leads to International Scare

The United Kingdom, EU member states, and other countries have suspended sales of products made by the Brazilian firm Silimed amidst an investigation into the safety of its products.  

Qmed Staff


A recent audit of the Brazilian company Silimed has triggered the biggest breast implant scare since the 2010 Poly Implant Prothèse (PIP) debacle, which ultimately led to the jailing of that company's CEO, the shuttering of PIP, and stricter regulatory requirements in the European Union.

In the Silimed case, however, it is still uncertain what the fallout might be. An audit of the company's manufacturing facility by a German notified body detected that some of the products were contaminated with an unknown substance. This in turn has led to the United Kingdom halting sales of Silimed-made product, which include breast implants, breast tissue expanders, and an array of other devices. The company makes 5000 types of implants used for everything from general surgery to bariatric surgery. Other countries such as Switzerland, Ireland and other EU member states, Australia, and New Zealand have also suspended sales of the products made by Silimed.

Santa Barbara, CA-based Sientra, who uses Silimed as a contract manufacturer, has seen its stock take a nosedive during the fallout tied to the alarming audit. On September 24, its stock fell more than 50%.

Silimed, which is the biggest maker of silicone implants in South America and claims to be the third largest implant manufacturer internationally, insists on its website that its products are safe. It adds, however, that it has voluntarily halted sales of its products until "on the European market until local health authorities have received the official technical report [regarding the recent audit]." The company's announcement goes on to say that the levels of unidentified particles was "extremely low" and claims that its products comply with regulatory requirements throughout the world.

The company had been the first South American firm to claim that its silicone breast implants had been approved by FDA.

It is theoretically possible that FDA may rescind its approval of Silimed products following the news, but there is little precedent of FDA following this course of action. It is also possible that the suspension of the CE Mark be overturned in a number of months. "We were able to identify at least one product where the CE mark was suspended and then lifted 3-6 months later; however, we do not believe the product was simultaneously sold in the U.S.," said Stifel analyst Jonathan Block on Streetinsider.

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8.

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