Essure Permanent Birth Control, Effectiveness and Safety: An Italian 11-Year Survey
| Autor: | Francesco Paolo Mangino, Gian Luigi Marchino, Gian Piero Fantin, Massimo Luerti, Stefano Calzolari, Giovanna Giarrè, Paolo Telloli, Attilio Di Spiezio Sardo, Cecilia Bonin, Stefania Calabrese, Pietro Litta, Elisa Scatena, Valentino Bergamini, Giovanni Borsellino, Enrico Busato, Federica Scrimin, Maria Antonietta Molinari, Brunella Zizolfi, Carmela Coppola, Mario Franchini |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
medicine.medical_specialty Sterilization Tubal Population Failure Pain Hysteroscopy Essure 03 medical and health sciences Young Adult Adverse events Hysteroscopic sterilization Obstetrics and Gynecology 0302 clinical medicine Nickel Pregnancy Surveys and Questionnaires medicine Hypersensitivity Humans 030212 general & internal medicine Hysterosalpingography education Laparoscopy Fallopian Tubes Retrospective Studies education.field_of_study 030219 obstetrics & reproductive medicine medicine.diagnostic_test business.industry Pelvic pain Sterilization Reproductive Pregnancy Unplanned Perioperative Middle Aged Surgery Tolerability Sterilization (medicine) Italy Female medicine.symptom business Follow-Up Studies |
| Zdroj: | Journal of minimally invasive gynecology. 24(4) |
| ISSN: | 1553-4669 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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