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 events relating to Essure last year, the majority of which were submitted in the last quarter of the year, Gottlieb said, in a Feb. 7 statement.
“We’re working to evaluate whether these cases reflect new safety concerns, as well as the extent to which they represent entirely new reports to the FDA or may have been reported in a prior safety filing. More than 90 percent of the reports in 2017 mentioned issues involving potential device removal, which the FDA is further investigating,” Gottlieb said.
Some of the adverse event reports do not indicate if or when the device was removed. “We’re actively working to gain more information on these new reports and to better understand reasons for the device removal,” Gottlieb said, adding that the agency will be following up on many individual reports to gather the additional information.
He said the agency will provide ongoing updates on its assessments of the data and will consider peer-reviewed medical studies on the device’s safety. Thus far, he wrote, such studies have generally aligned with agency assessments of Essure’s safety profile.
The FDA also will consider regulatory options in line with the device’s risks and benefits as it obtains new information, said. — Zack Budryk