Bayer (ETR:BAYN) failed to tell FDA about thousands of injury complaints related to its Essure contraceptive device, according to newly unsealed lawsuit documents reported by Bloomberg.
The lawsuit documents out of California claim that the underreporting went back before Bayer acquired Essure maker Conceptus for $1.1 billion in 2013. Bayer responded to Bloomberg last week that it continues to “stand behind Essure’s safety and efficacy” — with 270,000 women involved in Essure research over the past two decades.
FDA announced in 2018 that U.S. sales of the Bayer permanent birth control device would discontinue amid complaints from women about unexpected pregnancies and injuries following implantation. Essure has no longer been available for implantation in the U.S. since December 2019.
The Bloomberg report on July 10 came on the heels of FDA posting interim results of an Essure postmarket study that found higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding compared with laparoscopic tubal ligation as permanent birth control.
Essure-related adverse events reporting is showing no signs of slowing down, according to FDA data compiled by Device Events.