The Brazilian regulator Anvisa suspended the production, sale, and use of products made by Brazil’s Silimed—and this includes products manufactured for Sientra.
This news follows a decision last month by the UK’s Medicines & Healthcare Products Regulatory Agency to suspend sales of Silimed implants, including breast, penile, and testicular implants, due to potential contamination. Silimed is one of Sientra’s contract manufacturers.
Shares of Sientra dipped a further 20% to a 52-week low after the announcement by Anvisa.
Sientra is in discussions with the United States Food and Drug Administration (FDA) regarding this matter. It will continue to offer and make available its products to surgeons and patients in the United States. Sientra believes it currently has ample inventory to address current and near-term future demand. “We remain committed to patient safety and will keep our doctors and other stakeholders apprised of any new developments,” the company states in a press release.
At the time of the original announcement, Reuters reported that a spokesman for the UK’s Medicines & Healthcare products Regulatory Agency did not yet know whether any potentially contaminated products would have reached patients, and did not know how many Silimed products might be affected.
A German authority appointed to monitor Silimed “has recently carried out an inspection of the manufacturing plant in Brazil and established that the surfaces of some devices were contaminated with particles,” it said in a statement.
“For the moment, there has been no indication that these issues would pose a threat to the implanted person’s safety,” the group said in a statement.
The British Association of Aesthetic Plastic Surgeons weighed in as well. “Plastic surgeons have been informed not to implant these devices until further assessments have taken place and the CE Mark reinstated. We are not aware of any documented patient safety issues.”
In the Wake of PIP
The Silimed product suspension comes in the wake of the 2010 Poly Implant Prothèse (PIP) scandal. The PIP implants were not made with medical-grade silicone , resulting in a higher-than-normal rupture rate. Hundreds of thousands of patients across Europe and South America were affected, and PIP’s president, Jean-Claude Mas, was given a 4-year jail sentence in December 2013.
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