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    Essure and the risks of reoperation

    COG-SpecialDelivery-Issue_2641.jpg

    As the Food and Drug Administration continues to weigh the risk:benefit profile of Essure, a report published in BMJ is adding new data on outcomes with the device. Results of the population-based cohort study show that rates of unintended pregnancy are similar for hysteroscopic and laparoscopic sterilization but that Essure is associated with a 10-fold higher likelihood of reoperation.

    Recommended: FDA declares Essure safety a top priority

    Researchers from Cornell University analyzed data on more than 50,000 patients who underwent hysterscopic or laparoscopic sterilization between 2005 and 2013 in New York. The main outcomes examined were safety events occurring within 30 days of and unintended pregnancies or reoperations within 1 year after the procedures. A mixed model, which took into account hospital clustering, was used to compare the outcomes, after adjustment for patient characteristics and other confounders.

    During the study period, 8048 women were sterilized using the Essure device and 44,278 underwent laparoscopic sterilization. Over that time, utilization of hysteroscopic sterilization increased and utilization of laparoscopic sterilization decreased.

    Overall, women in whom the Essure device was used tended to be older than those sterilized laparoscopically. They were also more like to have a history of pelvic inflammatory disease (10.3% vs 7.2%, P<0.01), major abdominal surgery (9.4% vs 7.9%, P<0.01), and cesarean delivery (23.2% vs 15.4%, P<0.01).

    When compared with laparoscopic sterilization, Essure was not associated with a higher risk of unintended pregnancy after a year (odds ratio 0.84 [95% CI 0.63 to 1.12]). It was, however, associated with a substantially increased risk of reoperation (odds ratio 10.16 [7.47 to 13.81]).

    “With an estimated 600,000 sterilization procedures performed in the US every year,” the authors said, “the device-based hysteroscopic sterilization has a major public health impact, and comparative safety and effectiveness of sterilizations are important for decision making by patients and physicians. A registry based study is warranted to further understand the failure events after device use and improve the safety and efficacy of sterilization procedures.”

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    Judith M. Orvos, ELS
    Judith M. Orvos, ELS, is a a BELS-certified medical writer and editor and an editorial consultant for Contemporary OB/GYN.
    Miranda Hester
    Ms. Hester is Content Specialist with Contemporary OB/GYN and Contemporary Pediatrics.

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