P114. Adverse events of Essure® contraception. Analysis in a large cohort of patients.

Iuliia Naumova (ES), Jorge Duro-Gómez (ES), Marina Romero-Domínguez (ES), Ana Rodríguez-Marín (ES), Balbino Povedano-Cañizares (ES), José Arjona-Berral (ES), Camil Castelo Branco (ES)

[Naumova] University of Barcelona, Barcelona, [Duro-Gómez] Cordoba. Department of Gynecology and Obstetrics. Montilla Hospital., [Romero-Domínguez] Cordoba. Department of Gynecology and Obstetrics. Reina Sofía University Hospital, [Rodríguez-Marín] Cordoba. Department of Gynecology and Obstetrics. Hospital San Juan de Dios, [Povedano-Cañizares] Cordoba. Department of Gynecology and Obstetrics. Reina Sofía University Hospital, [Arjona-Berral] Cordoba. Department of Gynecology and Obstetrics. Hospital San Juan de Dios, [Castelo Branco] Institut Clinic of Gynecology, Obstetrics and Neonatology, Faculty of Medicine-University of Barcelona, Hospital Clinic-Institut d´Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS); Barcelona

ABSTRACT Objective: To analyse the reasons for Essure® removal in a large cohort of patients. Design: Retrospective 15-year study. Methods: From 2003 to 2015, 8024 Essure®device insertions were performed in a single centre in Córdoba (Spain). Of these, 156 patients (1.89%) presented adverse events requiring device withdrawal (SG). A subset of 156 women matched for age, clinical characteristics and time since insertion were used for case-control comparisons (CG). In 47 cases, the device had already been surgically removed. Three months later, patients were questioned regarding symptoms and their general condition. Main Outcome Measure(s): Peri and post-operative adverse events, early postoperative and late complications (after the initial 3 months) and patients’ satisfaction after procedures. Results: Pelvic pain as the most bothersome symptom was reported by 58.61% of patients (93) of the SG and 1.28 % (2) of the CG (p < 0.01). Among other complains heavy menstrual bleeding, allergy, asthenia, polyarthralgia and urinary tract infection occurred significantly more frequently in SG (p < 0.05). Of the 47 patients who had already undergone surgical device removal, 78.72% (37) reporting feeling well/very well, and 85.10% (40) felt better than before surgery. However, up to 93.67% (43) still had some complains. Conclusion: Appropriate patient selection and careful preoperative assessment are required. Women should be informed about the benefits and risks of hysteroscopic and traditional sterilisation. Keywords: Essure removal; Hysteroscopic sterilisation; Pelvic pain; Surgical outcomes; Symptom resolution