TY - JOUR T1 - Essure Permanent Birth Control, Effectiveness and Safety: An Italian 11-Year Survey. JF - J Minim Invasive Gynecol Y1 - 2017 A1 - Franchini, Mario A1 - Zizolfi, Brunella A1 - Coppola, Carmela A1 - Bergamini, Valentino A1 - Bonin, Cecilia A1 - Borsellino, Giovanni A1 - Busato, Enrico A1 - Calabrese, Stefania A1 - Calzolari, Stefano A1 - Fantin, Gian Piero A1 - Giarrè, Giovanna A1 - Litta, Piero A1 - Luerti, Massimo A1 - Mangino, Francesco Paolo A1 - Marchino, Gian Luigi A1 - Molinari, Maria Antonietta A1 - Scatena, Elisa A1 - Scrimin, Federica A1 - Telloli, Paolo A1 - Di Spiezio Sardo, Attilio KW - Adult KW - Fallopian Tubes KW - Female KW - Follow-Up Studies KW - Humans KW - Hypersensitivity KW - Hysterosalpingography KW - Hysteroscopy KW - Italy KW - Laparoscopy KW - Middle Aged KW - Nickel KW - Pain KW - Pregnancy KW - Pregnancy, Unplanned KW - Retrospective Studies KW - Sterilization, Reproductive KW - Sterilization, Tubal KW - Surveys and Questionnaires KW - Young Adult AB -

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.

VL - 24 IS - 4 U1 - http://www.ncbi.nlm.nih.gov/pubmed/28232037?dopt=Abstract ER -