FDA Investigating Attorney, Physician Beefs With Bayer’s Essure PMA
This article was originally published in The Gray Sheet
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.
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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.
US FDA has accepted a post-approval study plan by Bayer HealthCare for its Essure permanent sterilization device, which is under intense scrutiny in response to adverse events and charges of clinical trial misconduct. The protocol entails a non-randomized, six-year cohort study comparing Essure-implanted women to tubal ligation sterilization subjects.
FDA will publicly announce actions it will take on Bayer’s Essure permanent birth control device at the end of February 2016 following its full review of the medical literature, adverse events reports, and input received during and after a September 24 advisory panel meeting on Essure, the agency said in a posting on its website.