title: Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study.
abstract: OBJECTIVE
  To compare the safety and efficacy of hysteroscopic sterilization with the "Essure" device with laparoscopic sterilization in a large, all-inclusive, state cohort.
  
  
  METHODS
  Population based cohort study.
  
  
  METHODS
  Outpatient interventional setting in New York State.
  
  
  METHODS
  Women undergoing interval sterilization procedure, including hysteroscopic sterilization with Essure device and laparoscopic surgery, between 2005 and 2013.
  
  
  METHODS
  Safety events within 30 days of procedures; unintended pregnancies and reoperations within one year of procedures. Mixed model accounting for hospital clustering was used to compare 30 day and 1 year outcomes, adjusting for patient characteristics and other confounders. Time to reoperation was evaluated using frailty model for time to event analysis.
  
  
  RESULTS
  We identified 8048 patients undergoing hysteroscopic sterilization and 44,278 undergoing laparoscopic sterilization between 2005 and 2013 in New York State. There was a significant increase in the use of hysteroscopic procedures during this period, while use of laparoscopic sterilization decreased. Patients undergoing hysteroscopic sterilization were older than those undergoing laparoscopic sterilization and were more likely to have a history of pelvic inflammatory disease (10.3% v 7.2%, P<0.01), major abdominal surgery (9.4% v 7.9%, P<0.01), and cesarean section (23.2% v 15.4%, P<0.01). At one year after surgery, hysteroscopic sterilization was not associated with a higher risk of unintended pregnancy (odds ratio 0.84 (95% CI 0.63 to 1.12)) but was associated with a substantially increased risk of reoperation (odds ratio 10.16 (7.47 to 13.81)) compared with laparoscopic sterilization.
  
  
  CONCLUSIONS
  Patients undergoing hysteroscopic sterilization have a similar risk of unintended pregnancy but a more than 10-fold higher risk of undergoing reoperation compared with patients undergoing laparoscopic sterilization. Benefits and risks of both procedures should be discussed with patients for informed decisions making.
authors.affiliation: Department of Health Policy and Research, Weill Medical College of Cornell University, New York, NY 10065, USA.
authors.forename: Jialin
authors.initials: J
authors.lastname: Mao
authors.affiliation: Department of Obstetrics and Gynecology, Weill Medical College of Cornell University, New York-Presbyterian Hospital, New York, NY, USA.
authors.forename: Samantha
authors.initials: S
authors.lastname: Pfeifer
authors.affiliation: Department of Urology, Weill Medical College of Cornell University, New York-Presbyterian Hospital, New York, NY, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Schlegel
authors.affiliation: Department of Health Policy and Research, Weill Medical College of Cornell University, New York, NY 10065, USA.
authors.forename: Art
authors.initials: A
authors.lastname: Sedrakyan
mesh_terms: D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015907:Hysteroscopy / Q000379:methods*; D010535:Laparoscopy / Q000379:methods*; D011247:Pregnancy; D049168:Pregnancy, Unplanned; D012189:Retrospective Studies; D013245:Sterilization, Reproductive / Q000379:methods*; D016896:Treatment Outcome