title: Analysis of adverse events with Essure hysteroscopic sterilization reported to the Manufacturer and User Facility Device Experience database.
abstract: OBJECTIVE
  The Manufacturer and User Facility Device Experience database may be useful for clinicians using a Food and Drug Administration-approved medical device to identify the occurrence of adverse events and complications. We sought to analyze and investigate reports associated with the Essure hysteroscopic sterilization system (Conceptus Inc., Mountain View, CA) using this database.
  
  
  METHODS
  Retrospective review of the Manufacturer and User Facility Device Experience database for events related to Essure hysteroscopic sterilization from November 2002 to February 2012 (Canadian Task Force Classification III).
  
  
  METHODS
  Online retrospective review.
  
  
  METHODS
  Online reports of patients who underwent Essure tubal sterilization.
  
  
  METHODS
  Essure tubal sterilization.
  
  
  RESULTS
  Four hundred fifty-seven adverse events were reported in the study period. Pain was the most frequently reported event (217 events [47.5%]) followed by delivery catheter malfunction (121 events [26.4%]). Poststerilization pregnancy was reported in 61 events (13.3%), of which 29 were ectopic pregnancies. Other reported events included perforation (90 events [19.7%]), abnormal bleeding (44 events [9.6%]), and microinsert malposition (33 events [7.2%]). The evaluation and management of these events resulted in an additional surgical procedure in 270 cases (59.1%), of which 44 were hysterectomies.
  
  
  CONCLUSIONS
  Sixty-one unintended poststerilization pregnancies were reported in the study period, of which 29 (47.5%) were ectopic gestations. Thus, ectopic pregnancy must be considered if a woman becomes pregnant after Essure hysteroscopic sterilization. Additionally, 44 women underwent hysterectomy after an adverse event reported to be associated with the use of the device.
authors.affiliation: Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, University of Colorado Denver, Aurora, Colorado. Electronic address: zain.al-safi@ucdenver.edu.
authors.forename: Zain A
authors.initials: ZA
authors.lastname: Al-Safi
authors.forename: Valerie I
authors.initials: VI
authors.lastname: Shavell
authors.forename: Deslyn T G
authors.initials: DT
authors.lastname: Hobson
authors.forename: Jay M
authors.initials: JM
authors.lastname: Berman
authors.forename: Michael P
authors.initials: MP
authors.lastname: Diamond
mesh_terms: D000328:Adult; D016208:Databases, Factual; D005260:Female; D006801:Humans; D015907:Hysteroscopy / Q000009:adverse effects* / Q000295:instrumentation; D010146:Pain / Q000209:etiology*; D011247:Pregnancy; D011271:Pregnancy, Ectopic / Q000209:etiology*; D012189:Retrospective Studies; D013245:Sterilization, Reproductive / Q000009:adverse effects* / Q000295:instrumentation; D013246:Sterilization, Tubal / Q000009:adverse effects / Q000295:instrumentation
keywords: Essure; Manufacturer and User Facility Device Experience; Microinsert; Sterilization