title: Pre-hysterectomy assessment of immediate tubal occlusion with the third-generation ESSURE insert (ESS505).
abstract: OBJECTIVE
  To assess the ability of a new iteration of the ESSURE insert (ESS505) to achieve short-term fallopian tube occlusion.
  
  
  METHODS
  Prospective, single center, interventional cohort (Canadian Task Force classification II-1).
  
  
  METHODS
  Tertiary care hospital.
  
  
  METHODS
  Women scheduled to undergo hysterectomy.
  
  
  METHODS
  Patients underwent placement of the ESS505 in the right fallopian tube and ESS305 (the commercially approved previous version of the device) in the left fallopian tube at 30 (n = 10), 60 (n = 10), or 90 (n = 10) days before a planned hysterectomy. Tubal occlusion was assessed via hysterosalpingography (HSG) both at the time of placement and just before hysterectomy. Ultrasound was used to evaluate acute device placement.
  
  
  RESULTS
  Thirty-five women (mean age, 39.7 years) were enrolled from July 2012 to January 2013, and 30 underwent both ESSURE placement and scheduled hysterectomy. Mean (SD) placement time for the ESS305 and ESS505 devices was 1.4 (0.65) minutes and 1.3 (0.42) minutes, respectively (p = .36). At 1 hour after ESS505 placement, 29 of 30 tubes (97%) exhibited complete occlusion at HSG, compared with only 4 of 30 tubes (13%) after ESS305 placement (p < .001 for difference in occlusion rates). At hysterectomy, the tubal occlusion rate was high in both groups: 97% for ESS505 and 100% for ESS305 tubes. High occlusion rates were observed in each of the 3 duration groups (30, 60, and 90 days). Five women experienced only minor adverse effects.
  
  
  CONCLUSIONS
  ESS505, a modification to the commercially available ESS305 designed to cause immediate tubal occlusion, demonstrated a high rate of both immediate-term and intermediate-term tubal occlusion. Early tubal occlusion may obviate the need for interim alternative contraceptive methods after ESSURE placement.
authors.affiliation: Department of Obstetrics and Gynecology, University of Saskatchewan, Regina, Saskatchewan, Canada. Electronic address: john.thiel@usask.ca.
authors.forename: John
authors.initials: J
authors.lastname: Thiel
authors.affiliation: Department of Obstetrics and Gynecology, University of Saskatchewan, Regina, Saskatchewan, Canada.
authors.forename: Darrien
authors.initials: D
authors.lastname: Rattray
authors.affiliation: Wild Iris Consulting LLC, Palo Alto, California.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Cher
mesh_terms: D000328:Adult; D000818:Animals; D005186:Fallopian Tube Patency Tests / Q000379:methods; D005187:Fallopian Tubes / Q000601:surgery*; D005260:Female; D006801:Humans; D007044:Hysterectomy / Q000706:statistics & numerical data; D007047:Hysterosalpingography / Q000379:methods; D007434:Intrauterine Devices / Q000009:adverse effects; D008875:Middle Aged; D011183:Postoperative Complications / Q000175:diagnosis; D057234:Preoperative Period; D011446:Prospective Studies; D013246:Sterilization, Tubal / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods
keywords: Contraception; ESS505; ESSURE; Female sterilization; HSG/TVU; Hydrogel; Hysteroscopic sterilization; Permanent birth control