Study of Recalled Essure Implant Continues to Lose Participants, But FDA Reports Measures to Fix Data are Working
Federal regulators have released new data on recalled Essure birth control implants, indicating that it has been necessary for Bayer to take steps to improve data from a government-mandated study, due to high dropout rates among women who received Essure before it was recalled from the market.
Essure is a permanent birth control implant, involving flexible coils inserted into the fallopian tubes during an outpatient procedure. The device was intended to cause scar tissue to develop, which would block the tubes and prevent insemination. However, thousands of women experienced painful and debilitating Essure complications, including device fractures, migration, and organ perforation.
In 2018, the U.S. Food and Drug Administration (FDA) announced that Essure implants were being removed from the market. As part of the Essure recall, the federal regulators ordered Bayer to conduct post-marketing surveillance of women who had received the implant, to get a better sense of the long-term risks associated with the birth control device.
Essure Interim Study Results
On October 30, the agency released an Essure implant update, providing interim results of the ongoing post-marketing surveillance study, involving three years of follow-up on women who had received the implant.
About this time last year, the FDA had claimed progress on the Essure study was “inadequate”, due to a high dropout rate among participants. The dropout rates were so high that it was leading to poor data, with 47.4% of Essure patients having discontinued the study at that time, the FDA noted.
However, in this update, the agency says the situation with the Essure post-marketing study has improved, upgrading the status from “inadequate” to “ongoing”, even though the drop out rate has now exceeded 51%.
“At the request of FDA in 2022, Bayer developed and implemented additional strategies to improve follow up in the study. The current study status is ‘ongoing’ because the progress of the study is consistent with the study plan,” the FDA update notes. “The FDA will continue to monitor lost to follow-up rates in the study and work with Bayer to take additional measures as needed.”
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Essure Complication and Removal Rates
The FDA indicates that data collected in June determined that the rate of Essure device removal rates for any given reason was about 15.7%. Those who got the implant believing it would be a permanent form of birth control had the device removed about 12.3% of the time, the FDA determined.
Previous analyses have found that unintentional organ perforation rates with the Essure were 1.9%, nearly double the 1.1% rate linked to laparoscopic tubal sterilization: another form of permanent birth control.
A final analysis of the data will be made after researchers conduct a five-year follow-up with Essure patients in about two years, the agency indicates.
In March 2022, the FDA indicated it has received a total of 67,643 medical device reports linked to the Essure implant. While most reports received between 2013 and 2015 were voluntary submissions from women who received Essure implants, in 2021 98% of the 3,701 reports received by the FDA were submitted by Bayer. Of those, 85% were related to device removal, the FDA noted, and most were linked to litigation.
The manufacturer recalled the birth control implant only after thousands of Essure lawsuits were filed by women who experienced adverse health effects while implanted with the birth control device.
After several years in the court system, Bayer announced in 2020 that it would pay $1.6 billion to settle about 90% of all Essure cases pending at that time. However, with approximately 750,000 women worldwide implanted with the device, and 70% of those Essure procedures occurring in the United States, it is expected that additional lawsuits will be filed in the coming years as women continue to experience complications.
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