Dive Brief:
- FDA has updated its information about the removal of Bayer's Essure birth control devices with the latest results of postmarket studies.
- One of the studies found the rate of Essure device removal for all subjects for any reason rose from 15.5% at seven years of follow-up to 17.8% at eight years of follow-up. The second study put the rate of device removal after 22 months at 10%.
- FDA has continued to monitor Essure since Bayer stopped selling the device in the U.S. in late 2018, following tens of thousands of reports of complications. Bayer stood by the safety of the product and called its move a business decision.
Dive Insight:
Essure won approval in 2002 and offered women a permanent birth control option. By inserting metal coils into the fallopian tube, the device blocks the passage of eggs and thereby prevents pregnancy. Trials found the device to be safe and effective but women began to report health problems after receiving the implant, ultimately leading to a mountain of adverse event reports and lawsuits.
FDA updated the Information for Patients and Health Care Providers about Essure on Monday, but the new data are from analyses performed in July. In one study, researchers followed 620 women for 10 years after device placement. The other study enrolled 1,129 women who chose to either receive Essure or undergo laparoscopic tubal sterilization.
In the 620-patient study, researchers are tracking the rate of device removals. After eight years, Essure, a device designed to provide permanent birth control, had been removed from 17.8% of the subjects. The figure is up on the 15.5% removal rate seen after seven years. FDA cautioned that the study includes data from inside and outside the U.S., was not originally designed to collect data on device removal and does not convey the reason for removal. Some removals could be for reasons unrelated to complications.
The second study captures a broader range of data. In the 2020 analysis, the most common reasons for device removal were patient requests and management of adverse events related to Essure. The study is also looking at a range of safety endpoints that reveal the rate of chronic lower abdominal and/or pelvic pain in the Essure cohort in 2021 was 12.5%. That compares to 8.7% in the control arm in 2021 and 9.1% in the 2020 analysis of the Essure group.
Both studies are ongoing. FDA expects to receive the final report on the 620-subject device removal study in 2023. The final report from the larger trial comparing Essure to laparoscopic tubal sterilization is due in 2025.
