New surveillance data on women implanted with the ESSURE female sterilization device -- removed from the market in December 2018 -- confirm that substantial numbers suffer abnormal uterine bleeding and pelvic and lower abdominal pain compared to patients who had a laparoscopic tubal ligation, .
The data came from a prospective post-marketing study the FDA required from Essure's manufacturer, Bayer. It includes 1,128 women -- 340 assigned to Essure and 788 in a laparoscopic tubal ligation arm. Around 280 patients in the Essure group and 705 in the tubal ligation cohort had the respective procedures attempted, and success rates were 94.6% and 99.6%, respectively.
In , 9.1% of Essure patients reported chronic lower abdominal or pelvic pain, compared to 4.5% of the tubal ligation arm. The adjusted overall incidence of abnormal bleeding was 16.3% among Essure patients, compared to 10.2% in the tubal ligation cohort.
Almost 20% of patients in the Essure group had a gynecologic surgery after sterilization, compared to 3% in the tubal ligation group. The higher incidence of surgical procedures was driven mainly by Essure removals and endometrial ablations, and after adjustment rates were 7% and 0%, respectively.
Pregnancy rates were similar for both cohorts.
These findings follow a long history of controversy and litigation around the birth control device, ending with Bayer's decision 2 years ago to pull it off the U.S. market. Bayer reported that all unused devices have since been returned, and it was no longer available for implantation as of December 2019.
"The safety of Essure is supported by a robust body of scientific data," Bayer said in a statement to 番茄社区. "While all birth control products and procedures have risks, the totality of scientific evidence on Essure demonstrates that its safety profile is consistent with the risks disclosed since its 2002 approval and is comparable to other female permanent birth control options."
Bayer added that these interim findings are incomplete and subject to change, as the surveillance study will continue for around another four years.
Essure is a flexible metal coil inserted into the fallopian tubes, resulting in tissue growth that blocks sperm from entering.
Initially approved in 2002, the FDA started re-examining the device in 2015 following reports of numerous adverse events, including procedural complications, chronic pain, and unplanned pregnancies. An FDA advisory committee in 2015 suggested the device be reclassified with new label information, but stopped short of recommending its market removal.
Subsequent studies, however, further documented the high rate of adverse events, leading regulators in other countries to pull their approvals and, ultimately, Bayer to throw in the towel.
Current recommendations state that patients who have used Essure successfully without complications should not seek to have it explanted.
While the device is no longer available, the agency said that it will continue to monitor the long-term safety of Essure patients. In a statement, Terri Cornelison, MD, PhD, director of the FDA's Health of Women Program in the Center for Devices and Radiological Health, said that early results from this prospective study are aimed "to help patients and health care providers better understand complications women with Essure may experience."
The surveillance study will continue: the FDA will release a final report in 2025, and Cornelison promised another interim analysis before then.