Complications of hysteroscopic Essure® sterilisation: report on 4306 procedures performed in a single centre

Abstract

Please cite this paper as: Povedano B, Arjona J, Velasco E, Monserrat J, Lorente J, Castelo‐Branco C. Complications of hysteroscopic Essure^® sterilisation: report on 4306 procedures performed in a single centre. BJOG 2012;119:795–799. Objective To analyse the short‐, medium‐ and long‐term complications in women undergoing hysteroscopic tubal sterilisation with the Essure^® device. Design Retrospective 7‐year study. Setting Office hysteroscopic unit in a teaching hospital. Sample A total of 4306 women whoe underwent the Essure^® sterilisation procedure from 2003 to 2010. Methods Data on the success of the procedure and complications arising from outpatient hysteroscopic sterilisation using the Essure^® system were collected from consecutive women undergoing the procedure over a 7‐year period. Main outcome measures Placement rate, successful bilateral tubal occlusion, perioperative adverse events, early postoperative (during the first 3 months of follow‐up) and late complications (after the initial 3 months of follow‐up). Results A total of 4108 (96.8%) women completed the standard 3‐month follow‐up protocol. Only 534 (13%) women had undergone the procedure within the previous year. There were 115 (out of 4306; 2.7%) recorded complications, none of which resulted in the need for hospitalisation or discharge later than 2 hours after the procedure. Vasovagal syncope was the most frequently encountered adverse event, occurring in 85 (2.0%) of 4306 cases. In 19 cases, one device was expelled, with most expulsions (14 out of 19) being detected before or during the 3‐month follow‐up. Conclusions Outpatient hysteroscopic sterilisation using the Essure^® system is safe, with a low rate of complications.