Essure-Attributed Symptoms: Follow-up of a Large Cohort after Device Removal: A Retrospective Nested Case-Control Study

Abstract

Objective: To analyse the reasons for Essure® removal in a large cohort of patients. Design: Retrospective 15-year study. Setting: Office hysteroscopy unit in a teaching hospital. 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): Pre and post-operative adverse events, early postoperative and late complications (after the initial 3 months) and patients' satisfaction after procedures. Results: In the SG, 23.08% (36) of the patients were allergic to nickel compared to only 1.28% (2) in the CG (p<0.01). No differences were found in insertion difficulty or pain or related to the time with the device. Surprisingly, satisfaction was higher at 3 months in the SG compared to the CG (100% vs. 90.90 %, respectively (p=0.01)). Currently, 58.61% (93) of the SG and 1.28 % (2) of the CG report pelvic pain as the most bother some symptom (p<0.01). The SG described abundant menstrual bleeding, allergy, asthenia, polyarthralgia and urinary tract infection. 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 complaints. Conclusion: Appropriate patient selection and careful preoperative assessment are required. Women should be informed about the benefits and risks of hysteroscopy and traditional sterilisation.