FDA to Continue Analyzing Safety of Bayer Birth Control Device

FDA Commissioner Scott Gottlieb said the agency is evaluating thousands of adverse event reports for Bayer’s permanent birth control device Essure received in the past year.

The agency approved the device in 2002 and in February 2016 — responding to increased concerns about patients experiencing abdominal pain, device migration and abnormal uterine bleeding — ordered Bayer to conduct a postmarketing study to analyze the device’s safety profile and to add a boxed warning to its labeling.

The agency received nearly 12,000 adverse event reports relating to Essure last year, the majority of which were submitted in the last quarter of the year, Gottlieb said.