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FDA 'Black Box' Labeling For Essure Highlights Adverse Events With Bayer Sterility Device

Executive Summary

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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