Interim results from a postmarket study of the Bayer (ETR:BAYN) Essure permanent birth control device revealed higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding compared with laparoscopic tubal ligation as permanent birth control.
The FDA posted the results as part of a long-term safety evaluation of the device, which has been the subject of thousands of lawsuits worldwide. Essure has not been available for implantation in the U.S. since December 2019, having had U.S. sales for the device discontinued in December 2018.
Essure patients also reported higher rates of gynecologic surgical procedures, including surgery to remove Essure, than patients who had tubal ligation, according to Dr. Terri Cornelison, the director of the FDA Health of Women Program in the Center for Devices and Radiological Health. Pregnancy rates are similar for patients with Essure or tubal ligation.
In February 2016, the FDA ordered Bayer to collect more data on the benefits of Essure and compare them to laparoscopic tubal ligation, then ordered an extension of the postmarket surveillance study from 3 years to 5 in December 2018. Enrollment has since ended and the 5-year follow-up is ongoing and patients are still completing one-year follow-up visits.
The federal watchdog said it had received approximately 6,000 adverse event reports about Essure in 2018, a decrease from the nearly 12,000 it received in 2017 but close to the numbers it received in 2015 and 2016. Most reports received by the agency last year were submitted by Bayer and were related to litigation against the company, with most reports mentioning device removal, according to FDA.
Patient safety activist Madris Tomes, however, painted a more sobering picture on Twitter. The Device Events CEO and a former FDA manager shared FDA data compiled by her company that showed no slowdown in 2019 and 2020 in Essure-related adverse events reporting:Cornelison said in an FDA statement that although Essure is no longer available for implantation in the U.S., the FDA remains committed to evaluating long-term safety information in women who have received the device.
“The FDA is working with Bayer, Essure’s manufacturer, to modify its study to include an additional interim analysis at 1 year of follow-up after patients’ permanent birth control procedure — this is earlier than the previously planned analysis at three years,” Cornelison said. “We believe this change is important to continue to closely monitor patient outcomes and communicate about the results in a more meaningful way.”
The agency still recommends that women who have been using Essure successfully to prevent pregnancy can and should continue to do so. However, women who suspect the device may be related to symptoms that include persistent pain should talk to their doctor about what steps may be appropriate.