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.