Essure Permanent Birth Control, Effectiveness and Safety: An Italian 11-Year Survey.
J Minim Invasive Gynecol
; 24(4): 640-645, 2017.
Article
em En
| MEDLINE
| ID: mdl-28232037
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 MAINRESULTS:
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Esterilização Reprodutiva
/
Esterilização Tubária
Tipo de estudo:
Etiology_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Adult
/
Female
/
Humans
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Middle aged
/
Pregnancy
País/Região como assunto:
Europa
Idioma:
En
Revista:
J Minim Invasive Gynecol
Assunto da revista:
GINECOLOGIA
Ano de publicação:
2017
Tipo de documento:
Article