The US Food and Drug Administration (USFDA) has approved an updated protocol for the Essure 522 post-market surveillance study, following discussions with Bayer about the study. The 522 post-market surveillance study is a prospective observational study comparing the health outcomes of women with Essure and women that have undergone laparoscopic tubal sterilization, the only other method of permanent birth control available to women. Bayer has worked closely with the FDA on the study’s design and implementation, and the recent modifications are a result of this ongoing cooperation. The protocol updates, which expand data collection and better reflect real-world conditions, specify that Bayer will continue to enroll patients in the study in 2019; follow patients for five rather than three years; additional blood tests; and, amend some inclusion and exclusion criteria for study enrollment. The benefit-risk profile of Essure has not changed.
In 2002, FDA approved Essure as a part of the agency’s rigorous premarket approval (PMA) process. Bayer continues to stand behind the product’s safety and efficacy, which are demonstrated by an extensive body of research, undertaken by Bayer and independent medical researchers, involving more than 200,000 women over the past two decades. Studies show that Essure has a strong track record of efficacy, preventing pregnancy in 99.3 percent of Essure patients who had a satisfactory confirmation test. In the pre-approval clinical trials, 99 percent of women were reported to have rated the comfort of wearing the Essure inserts as good or excellent. Earlier this year, on July 20, Bayer announced its business decision to voluntarily discontinue sales and distribution of Essure in the US after December 31, 2018, due to a decline in sales. Bayer will continue to fully comply with its regulatory responsibilities regarding Essure.