FDA 'Black Box' Labeling For Essure Highlights Adverse Events With Bayer Sterility Device
A US FDA final guidance on hysteroscopically placed tubal implant permanent sterilization devices calls for a "black box" warning, pointing out perforation, pain, allergic reactions and other potential adverse events uncovered for Bayer's Essure device. It emphasizes the importance for physicians to employ a patient-decision checklist with the products.
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Bayer AG said Sept. 18 it will not renew a CE mark for its Essure permanent contraceptive coils for women in EU countries, effectively halting sales of the product outside the US. The firm says its decision was "unrelated to product safety or efficacy," and driven by its commercial strategy. Meanwhile, US FDA calls for warnings and black box labels for Essure in the US, and says a Sec. 522 post-market study it ordered Bayer to complete "will help us better understand" thousands of complaints about the device.
FDA completed its investigation of a February 2015 trade complaint that charged clinical trial misconduct by Bayer HealthCare LLC for its controversial Essure permanently implanted birth control device, finding Bayer's response "satisfactory." The agency also approved amended labeling for the device.
A bipartisan coalition of seven members of the US House asked Energy and Commerce Committee leaders to hold hearings on medical device safety, trying to bring more attention to provisions that might strengthen safety oversight amid all the talk of accelerating medical innovation.