FDA Releases Details of Essure Postmarket Surveillance Studies
Federal regulators have released data from an ongoing postmarketing study into the side effects of Essure birth control implants, which face new restrictions in the U.S. and which have been recalled from the market throughout much of the rest of the world.
The FDA posted data on ongoing Essure studies to its Postmarket Surveillance Studies Webpage this week, declaring that the study is making adequate progress.
The information comes just days after the FDA made changes to Essure’s premarket approval, requiring both doctors and patients to sign off on a checklist of potential Essure complications.
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Essure is designed to provide permanent protection against pregnancy, involving an outpatient procedure where coils are placed in the uterus, which develop scar tissue that prevent pregnancy. However, thousands of women have experienced painful and debilitating injuries when the coils migrated, perforated the uterus or Fallopian tubes, caused allergic reactions, infections or other complications.
According to FDA Commissioner Scott Gottlieb, the FDA received about 12,000 adverse event reports related to the Essure birth control implant last year.
Bayer has withdrawn the Essure from every market in the world except the United States, and many women who say they were injured by the device, some of whom have filed Essure injury lawsuits, had urged the FDA to issue an Essure recallhere as well.
Gottlieb previously indicated that the FDA was waiting for Bayer to finish a safety study, which involves 2,800 women and is designed to examine the side effects of Essure coils. That study is not expected to be completed until 2023.
According to this latest update, the study has recruited 416 patients as of April 11, with 176 in the Essure arm of the study and 240 for the laparoscopic tubal ligation arm. The study has enrolled 62 study sites to date.
The study will have a number of main safety endpoints, including chronic lower abdominal or pelvic pain, abnormal uterine bleeding, hypersensitivity and allergic reactions, autoimmune disorders, the need for surgical removal, as well as other adverse events and rates of pregnancy.
Approximately 750,000 women worldwide have been implanted with the device, and Bayer has previously estimated that 70% of those have been implanted in women in the U.S.
The manufacturer has reportedly spent about $413 million defending the Essure litigation over the last year, and may face substantially greater liability at trial if Essure settlements or another resolution for the cases is not reached.
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