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Expect Bayer To Get Heat At FDA Advisory Panel Over Essure Adverse Events, Doc Training

This article was originally published in The Gray Sheet

Executive Summary

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.


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FDA Says Bayer's Response To Essure Investigation Satisfactory; Approves Product Label
FDA Investigating Attorney, Physician Beefs With Bayer’s Essure PMA
Essure Panel Stresses Need For Patient Follow-Up, But Stressed-Out Patients Say, ‘Recall It’
Bayer Buys Essure Contraceptive-Maker Conceptus For $1.1 Billion
Conceptus Essure Contraceptive Approved Three Months Post-Panel Review
Conceptus Essure Contraceptive Could Go To Panel As Early As July


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