Essure Permanent Birth Control, Effectiveness and Safety: An Italian 11-Year Survey

Mario Franchini, Brunella Zizolfi, Carmela Coppola, Valentino Bergamini, Cecilia Bonin, Giovanni Borsellino, Enrico Busato, Stefania Calabrese, Stefano Calzolari, Gian Piero Fantin, Giovanna Giarrè, Piero Litta, Massimo Luerti, Francesco Paolo Mangino, Gian Luigi Marchino, Maria Antonietta Molinari, Elisa Scatena, Federica Scrimin, Paolo Telloli, Attilio Di Spiezio Sardo

Research output: Contribution to journalArticlepeer-review

Abstract

Study Objective To describe safety, tolerability, and effectiveness results through a minimum 2-year follow-up of patients who underwent permanent sterilization with the Essure insert. Design A retrospective multicenter study (Canadian Task Force classification II2). Setting Seven general hospitals and 4 clinical teaching centers in Italy. Patients A total of 1968 women, mean age 39.5 years (range, 23–48 years) who underwent office hysteroscopic sterilization using the Essure insert between April 1, 2003, and December 30, 2014. Intervention The women underwent office hysteroscopic bilateral Essure insert placement, with satisfactory device location and tube occlusion based on hysterosalpingography or hysterosalpingo-contrast sonography (HyCoSy). Measurements and Main Results Placement rate, successful bilateral tubal occlusion, perioperative adverse events, early postoperative (during the first 3 months of follow-up), and late complications were evaluated. Satisfactory insertion was accomplished in 97.2% of women and, in 4, perforation and 1 expulsion were detected during hysterosalpingography. Three unintended pregnancies occurred before the 3-month confirmation test. Two pregnancies were reported among women relying on the Essure inserts. Postprocedure pain was minimal and brief; in 9 women, pelvic pain became intractable, necessitating removal of the devices via laparoscopy. On telephone interviews, overall satisfaction was rated as “very satisfied” by the majority of women (97.6%), and no long-term adverse events were reported. Conclusion The findings from this extended Italian survey further support the effectiveness, tolerability, and satisfaction of Essure hysteroscopic sterilization when motivated women are selected and well informed of the potential risks of the device. Moreover, the results do not demonstrate an increased incidence of complications and pregnancies associated with long-term Essure use. Patients with a known hypersensitivity to nickel may be less suitable candidates for the Essure insert.

Original languageEnglish
Pages (from-to)640-645
Number of pages6
JournalJournal of Minimally Invasive Gynecology
Volume24
Issue number4
DOIs
Publication statusPublished - May 1 2017

Keywords

  • Adverse events
  • Essure
  • Failure
  • Hysteroscopic sterilization

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

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