title: Essure® and chronic pelvic pain: a population-based cohort.
abstract: The aim of this study was to assess the incidence of chronic pelvic pain in women after placement of Essure® microinserts. This was a case series study at the hysteroscopy unit in a teaching hospital. We included 4,274 patients undergoing permanent sterilisation with Essure® microinserts from January 2005 to December 2011. Essure devices were removed in all patients reporting pelvic pain after insertion. All data were collected from the hysteroscopy unit database with later review of medical records in cases of chronic pelvic pain and a telephone survey after microinsert removal. Main outcome measures were: grade of procedure difficulty perceived by the surgeon; tolerance described by the patient after placement; the need for analgesics during or immediately after the procedure; side-effects; average time between device placement and the onset of symptoms; time between device placement and removal; technique for device removal and any symptoms thereafter. A total of seven women (0.16%) presented with chronic pelvic pain requiring microinsert removal, with four classifying the pain perceived during the procedure as medium-high. Six patients did not require analgesics after the procedure and a vasovagal syndrome requiring intravenous analgesia and monitoring occurred in only one case. Six women reported pain immediately after the procedure, with a mean time between placement and removal of 29.4 months. In all cases, the symptoms disappeared after Essure removal. We conclude that the development of chronic pelvic pain is very uncommon after placement of Essure microinserts. Removal of these devices usually improves the pain.
authors.affiliation: Unit of Obstetrics and Gynecology, Hospital Universitario Reina Sofía , Córdoba.
authors.forename: J E
authors.initials: JE
authors.lastname: Arjona Berral
authors.forename: B
authors.initials: B
authors.lastname: Rodríguez Jiménez
authors.forename: E
authors.initials: E
authors.lastname: Velasco Sánchez
authors.forename: B
authors.initials: B
authors.lastname: Povedano Cañizares
authors.forename: J
authors.initials: J
authors.lastname: Monserrat Jordan
authors.forename: J
authors.initials: J
authors.lastname: Lorente Gonzalez
authors.forename: C
authors.initials: C
authors.lastname: Castelo-Branco
mesh_terms: D000328:Adult; D002908:Chronic Disease; D015331:Cohort Studies; D005260:Female; D006801:Humans; D017699:Pelvic Pain / Q000209:etiology*; D013246:Sterilization, Tubal / Q000009:adverse effects* / Q000295:instrumentation
keywords: Adverse events; Essure®; chronic pelvic pain; hysteroscopic tubal sterilisation