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FDA Investigating Attorney, Physician Beefs With Bayer’s Essure PMA

This article was originally published in The Gray Sheet

Executive Summary

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.

Six-Year Study Will Compare Bayer’s Essure With Tubal Ligation

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.

Next Steps For Bayer’s Essure Device Coming In February, FDA Says

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