Patients Letter to GOP Rep. Chaffetz Urges Essure Probe

Patient group Essure Problems and Ennis & Ennis Law have written Congressman Jason Chaffetz (R-UT) urging a congressional investigation and hearing request over FDA’s approval of Bayer’s Essure contraceptive and alleged injuries caused by the device. Chaffetz is chairman of the House Committee on Oversight and Government Reform.

 

The letter says the investigation is needed because Essure’s clinical trials were inadequate and inappropriate from the beginning. “The clinical trials were insufficient as they followed too few women for too short a period of time,” the letter says. “The premarket approval was based on two non-randomized, non-blinded, prospective studies that lacked a comparator group and enrolled a total of 926 women.” The letter also complained that FDA did not weigh accordingly complaints about serious side effects and injuries tied to Essure.