Bayer Agrees To Pull Essure Off the U.S. Market

Bayer Agrees To Pull Essure Off the U.S. Market

Introduction

Bayer recently announced to take Essure Birth control device off the U.S. market by the end of 2018, blaming “inaccurate and misleading publicity” for poor sales. The decision was made following FDA's move to modify premarket approval (PMA) process for Essure in April 2018, considering about 12,000 adverse event reports that the birth control device was defectively designed. The FDA has ordered Bayer to conduct postmarket studies on the device's safety and effectiveness. The data for the same must be presented by them at the most by 2023.

Thousands of women affected due to the faulty device have filed lawsuits claiming complications ranging from hair loss to organ perforation. Essure lawsuits are filed individually by each plaintiff and not as class actions. The U.S was the last country where Bayer's  Essure was sold.