Essure was originally created and manufactured by Conceptus Inc., and was approved by the FDA in November of 2002. Back in 2013 Bayer acquired Conceptus, and now Essure is marketed by Bayer.
Since the moment it came out on the market, the FDA has been receiving complaints about the device. The FDA has received over 5,000 adverse reports concerning Essure, and they continue to receive reports. In June of 2015, the FDA notified consumers that it planned to hold a meeting with obstetricians and gynecologists to discuss the risks and benefits associated with Essure. After the meeting, which was held in September of that year, the FDA announced in February of 2016 that it was ordering Bayer to conduct a post-market surveillance study of Essure, that the device must now include a “black box” warning and that doctors must review a patient decision checklist with every patient, and that the FDA was in the process of completing its evaluation of the trade complaint regarding allegations of clinical trial misconduct during Essure’s original clinical trials.
Due to the serious health complications associated with Essure, women are beginning to file suit against Bayer for their injuries, and the lawsuits continue to increase throughout the country.