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

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.