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.
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.
Authors: Mitchell M Conover; Jennifer O Howell; Jennifer M Wu; Alan C Kinlaw; Nabarun Dasgupta; Michele Jonsson Funk Journal: Pharmacoepidemiol Drug Saf Date: 2015-03-31 Impact factor: 2.890
Authors: Giuseppe Ricci; Stefano Restaino; Giovanni Di Lorenzo; Francesco Fanfani; Federica Scrimin; Francesco P Mangino Journal: Ther Clin Risk Manag Date: 2014-11-17 Impact factor: 2.423