title: Complications of hysteroscopic Essure(®)  sterilisation: report on 4306 procedures performed in a single centre.
abstract: OBJECTIVE
  To analyse the short-, medium- and long-term complications in women undergoing hysteroscopic tubal sterilisation with the Essure(®) device.
  
  
  METHODS
  Retrospective 7-year study.
  
  
  METHODS
  Office hysteroscopic unit in a teaching hospital.
  
  
  METHODS
  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.
  
  
  METHODS
  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.affiliation: Department of Obstetrics and Gynaecology, 'Reina Sofía' University Hospital, Córdoba, Spain.
authors.forename: B
authors.initials: B
authors.lastname: Povedano
authors.forename: J E
authors.initials: JE
authors.lastname: Arjona
authors.forename: E
authors.initials: E
authors.lastname: Velasco
authors.forename: J A
authors.initials: JA
authors.lastname: Monserrat
authors.forename: J
authors.initials: J
authors.lastname: Lorente
authors.forename: C
authors.initials: C
authors.lastname: Castelo-Branco
mesh_terms: D000328:Adult; D004868:Equipment Failure / Q000706:statistics & numerical data; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015907:Hysteroscopy; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology*; D012189:Retrospective Studies; D013246:Sterilization, Tubal / Q000295:instrumentation / Q000379:methods*; D019462:Syncope, Vasovagal / Q000453:epidemiology / Q000209:etiology; D055815:Young Adult