Bayer Buys Essure Contraceptive-Maker Conceptus For $1.1 Billion
This article was originally published in The Gray Sheet
Executive Summary
The acquisition will add a popular nonsurgical, permanent birth control device to Bayer’s line of contraceptive pharmaceuticals and women’s health products.
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FDA Investigating Attorney, Physician Beefs With Bayer’s Essure PMA
FDA is investigating claims in a Citizen’s Petition by plaintiff’s attorneys that patients’ responses to the Essure permanent birth control device were tampered with in the pivotal trial, and two gynecologists' complaints of inflated marketing.
Expect Bayer To Get Heat At FDA Advisory Panel Over Essure Adverse Events, Doc Training
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.