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A review of clinical data for currently approved hysteroscopic sterilization procedures
1Basinski, LLC Newburgh, IN.
Abstract:
TWO HYSTEROSCOPIC PERMANENT STERILIZATION PROCEDURES ARE APPROVED FOR USE IN THE UNITED STATES: Essure® Permanent Birth Control System (Conceptus Incorporated, Mountain View, CA) and Adiana® Permanent Contraception (Hologic, Inc., Bedford, MA). This review compares the clinical trial data for these procedures. A notable difference is the resultant clinical pregnancy risk. The clinical trials for the Essure procedure have reported no pregnancies in 643 relying women in the 9 years since initiation of the studies. The clinical trial for the Adiana procedure has reported 12 pregnancies in 570 relying women in nearly 5 years of collected data. Other clinical outcome parameters concerning Essure and Adiana are examined in this review.
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