Essure®: Effectiveness, Complications and Satisfaction in 13 Years of Experience

Félix, N; Carvalho, C; Isidro Amaral, P; Sousa, F; Delgado, E; Machado, AI; Mira, R

http://hdl.handle.net/10400.17/4164

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Overview and aims: Female sterilization is the most used contraceptive method in the world. The hysteroscopic route is especially attractive for women at high surgical and anesthetic risk. Publications worldwide reported several possible adverse events, doubting the safety of the method. The objectives of this study are to evaluate the technical difficulties and complications, the adverse events in the short and long term, the effectiveness of the method and satisfaction. Study design: Retrospective cohort study. Population: A total of 105 women undergoing hysteroscopic sterilization with Essure® between 2005 and 2017 (13 years of study). Methods: The epidemiological and procedural data were accessed by consulting the clinical processes the family planning appointments. Long term follow-up was evaluated by telephone contact of all the women, with success in 68 cases. Results: The mean age was 38 years (SD 4,7). The procedure was successful in the first attempt in 99% (n=67) cases, the main technical difficulty identified was the permeabilization of the internal cervical os (8.6%; n=6) and the only intercurrence documented was vasovagal reaction (4.8%; n=3). The mean immediate pain post procedure was 4 (numeric pains cale, SD 2). Long term complications identified were: 1.5% (n=1) migration, 1.5% (n=1) partial unilateral expulsion, 4.4% (n=3) gynecological reoperation, 9% (n=7) headache, 11.8% (n=8) weight gain, 22.1% (n=15) chronic pelvic pain and 24.6% (n=17) abnormal uterine hemorrhage. There were no cases of pregnancy or allergic reaction. Most women were very or completely satisfied and would advise Essure® as a contraceptive method, 94% (n=64) and 97.1% (n=66) respectively. Conclusions: Hysteroscopic sterilization was highly effective and associated with low and mild difficulties and acute complications. Most women were satisfied with the method and long term adverse effects identified are difficult to promptly associate with Essure® since their high frequency in the peri-menopause, forcing more studies.