A Meta-Analysis of Bilateral Essure® Procedural Placement Success Rates on First Attempt.

Abstract

Background: The Essure® (Bayer HealthCare Pharmaceuticals, Leverkusen, Germany) female sterilization procedure entails using a hysteroscope to guide a microinsert into the Fallopian tube openings. Failed placement can lead to patient dissatisfaction, repeat procedures, unintended or ectopic pregnancy, perforation of internal organs, or need for subsequent medical interventions. Additional interventions increase women's health risks, and costs for patients and the health care industry. Demonstrated successful placement rates are 63%-100%. To date, there have not been any systematic analyses of variables associated with placement rates. Objectives: The aims of this review were: (1) to estimate the average rate of successful bilateral Essure microinsert placement on first attempt; and (2) to identify variables associated with successful placement. Materials and Methods: A meta-analysis was conducted on 64 published studies and 19 variables. Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, all published studies between November 2001 and February 2015 were reviewed. The studies were taken from from PubMed and Google Scholar, and by using the the "snowball" method that reported variables associated with successful bilateral Essure placement rates. Results: The weighted average rate of successful bilateral microinsert placement on first attempt was 92% (0.92 [95% confidence interval: 0.904-0.931]). Variables associated with successful placements were: (1) newer device models; (2) higher body mass index; and (3) a higher percent of patients who received local anesthesia. Conclusions: The data gathered for this review indicate that the highest bilateral success rates may be obtained by utilizing the newest Essure device model with local anesthesia in heavier patients. More standardized data reporting in published Essure studies is recommended. (J GYNECOL SURG 31:308).