title: Essure Permanent Birth Control, Effectiveness and Safety: An Italian 11-Year Survey.
abstract: To describe safety, tolerability, and effectiveness results through a minimum 2-year follow-up of patients who underwent permanent sterilization with the Essure insert.
  
  
  
  A retrospective multicenter study (Canadian Task Force classification II2).
  
  
  
  Seven general hospitals and 4 clinical teaching centers in Italy.
  
  
  
  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.
  
  
  
  The women underwent office hysteroscopic bilateral Essure insert placement, with satisfactory device location and tube occlusion based on hysterosalpingography or hysterosalpingo-contrast sonography (HyCoSy).
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Department of Obstetrics and Gynecology, Tuscany Regional Health Agency, Florence, Italy. Electronic address: framagi@alice.it.
authors.forename: Mario
authors.initials: M
authors.lastname: Franchini
authors.affiliation: Department of Obstetrics and Gynecology, University of Naples "Federico II", Naples, Italy.
authors.forename: Brunella
authors.initials: B
authors.lastname: Zizolfi
authors.affiliation: Department of Obstetrics and Gynecology, University of Naples "Federico II", Naples, Italy.
authors.forename: Carmela
authors.initials: C
authors.lastname: Coppola
authors.affiliation: Department of Obstetrics and Gynecology, University of Verona, Verona, Italy.
authors.forename: Valentino
authors.initials: V
authors.lastname: Bergamini
authors.affiliation: Department of Obstetrics and Gynecology, University of Verona, Verona, Italy.
authors.forename: Cecilia
authors.initials: C
authors.lastname: Bonin
authors.affiliation: Department of Obstetrics and Gynecology, Saronno Hospital, Saronno, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Borsellino
authors.affiliation: Department of Obstetrics and Gynecology, Santa Maria di Ca' Foncello Hospital, Treviso, Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Busato
authors.affiliation: Department of Obstetrics and Gynecology, Lodi Public Hospital, Lodi, Italy.
authors.forename: Stefania
authors.initials: S
authors.lastname: Calabrese
authors.affiliation: Department of Obstetrics and Gynecology, Palagi Freestanding Unit, Florence, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Calzolari
authors.affiliation: Department of Obstetrics and Gynecology, Conegliano Hospital, Conegliano, Italy.
authors.forename: Gian Piero
authors.initials: GP
authors.lastname: Fantin
authors.affiliation: Department of Obstetrics and Gynecology, Palagi Freestanding Unit, Florence, Italy.
authors.forename: Giovanna
authors.initials: G
authors.lastname: Giarrè
authors.affiliation: Department of Obstetrics and Gynecology, University of Padua, Padua, Italy.
authors.forename: Piero
authors.initials: P
authors.lastname: Litta
authors.affiliation: Istituto Clinico Cittá Studi, Milan, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Luerti
authors.affiliation: Department of Obstetrics and Gynecology, Institute for Maternal and Child Health, Istituto di Ricovero e Cura a carattere Scientifico "Burlo Garofolo", Trieste, Italy.
authors.forename: Francesco Paolo
authors.initials: FP
authors.lastname: Mangino
authors.affiliation: Department of Obstetrics and Gynecology, Department of Surgical Sciences, A. Anna Hospital, University of Torino, Torino, Italy.
authors.forename: Gian Luigi
authors.initials: GL
authors.lastname: Marchino
authors.affiliation: Department of Obstetrics and Gynecology, Saronno Hospital, Saronno, Italy.
authors.forename: Maria Antonietta
authors.initials: MA
authors.lastname: Molinari
authors.affiliation: Department of Obstetrics and Gynecology, Prato Hospital, Florence, Italy.
authors.forename: Elisa
authors.initials: E
authors.lastname: Scatena
authors.affiliation: Department of Obstetrics and Gynecology, Institute for Maternal and Child Health, Istituto di Ricovero e Cura a carattere Scientifico "Burlo Garofolo", Trieste, Italy.
authors.forename: Federica
authors.initials: F
authors.lastname: Scrimin
authors.affiliation: Lecco Hospital, Lecco, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Telloli
authors.affiliation: Department of Obstetrics and Gynecology, University of Naples "Federico II", Naples, Italy.
authors.forename: Attilio
authors.initials: A
authors.lastname: Di Spiezio Sardo
mesh_terms: D000328:Adult; D005187:Fallopian Tubes / Q000000981:diagnostic imaging; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006967:Hypersensitivity; D007047:Hysterosalpingography; D015907:Hysteroscopy; D007558:Italy; D010535:Laparoscopy; D008875:Middle Aged; D009532:Nickel / Q000009:adverse effects; D010146:Pain / Q000209:etiology; D011247:Pregnancy; D049168:Pregnancy, Unplanned; D012189:Retrospective Studies; D013245:Sterilization, Reproductive / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D013246:Sterilization, Tubal / Q000009:adverse effects / Q000379:methods*; D011795:Surveys and Questionnaires; D055815:Young Adult
chemical_list: D009532:Nickel
keywords: Adverse events; Essure; Failure; Hysteroscopic sterilization