FDA’s Obstetrics and Gynecology Devices Advisory Panel will discuss risk mitigation for pain, bleeding, and other events associated with its Essure sterility device on Sept. 24. Meanwhile, Bayer’s new summary for the meeting reveals several lawsuits were filed against it “making allegations [on] clinical trials and safety,” of Essure. A Citizen Petition says altered trial patient records and violations of adverse event reporting rules by Conceptus in 2011 invalidates its PMA.
Among the questions FDA’s Obstetrics and Gynecology Devices Advisory Panel is expected to discuss at a Sept. 24 panel meeting on Bayer HealthCare LLC’s Essure permanent birth control device are risk mitigation strategies for pain, bleeding and other adverse events associated with use of the device.
An unusual, 3-hour “open public hearing” session planned for the marathon advisory panel meeting – which will stretch, overall, from...