P359. Hysteroscopic intratubal device Essure® for permanent contraception: clinical outcomes and complications

Anne Pereira (BR), Walter Pinheiro (BR), Renata Geraldo (BR), Edson Ferreira Filho (BR), José Soares Júnior (BR), Ricardo Simões (BR), Maria Cândida Rezende (BR), Edmund Baracat (BR)

[Pereira] Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, [Pinheiro] Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, [Geraldo] Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, [Ferreira Filho] Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, [Soares Júnior] Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, [Simões] Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, [Rezende] Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, [Baracat] Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Context: The intratubal device (ITD) Essure® is a sterilization method approved in 2002 by the FDA (Food and Drug Administration), inserted hysteroscopically. Since it is performed in an outpatient setting and does not require anesthesia, it is more advantageous than other surgical methods. Objective: To evaluate the adverse events occurring in the use of the ITD in our service. Methods, Patients and Intervention: A cross-sectional, observational study in which patients submitted to the ITD insertion at HC-FMUSP from 2008 to 2016 were included. The analyzed variables were age, body mass index (BMI), parity and contraceptive method previously used. Main Outcome Measures: All patients who presented with pregnancy, migration, allergic reaction or expulsion of the ITD and altered menstrual flow were selected for complete analysis. Results: In our series, patients had a mean of 32 years. The most used contraceptive methods were: combined pill (41.6%), condom (33.0%) and quarterly injectable (25.4%). Of the 1255 cases analyzed, 12 (0.95%) of them had one of the mentioned adverse events. There were four (0.32%) pregnancies, six (0.48%) migrations, one expulsion (0.08%) and one patient reported allergic reaction (0.08%) one week after insertion of ITD. Among the four cases of pregnancy, the patients had suspended the contraceptive method before confirming the tubal obstruction. In addition, these patients had not performed the protocol-oriented procedures (quarterly and semiannual controls, namely: ultrasonography and / or hysterosalpingography) properly. Among the cases of migration, all the patients were asymptomatic and the diagnosis was made in the first ultrasonographical control, three months after the insertion of the ITD. The only case in which ITD expulsion was observed had technical intercurrence at insertion due to failure of the device release mechanism. The case of allergic reaction to DIT was mild, solved with the use of antihistamines after 14 days, with no need to remove the device. Finally, changes in the menstrual pattern for more were reported by 10% of the patients. Bilateral tubal obstruction failure was not characterized as an adverse event and occurred in thirteen (1.0%) cases. Conclusions: This study shows that ITD is a safe, easy-to-perform, ambulatory level instrument, with good results for its goal, female surgical sterilization.