Dutch Nationwide Multicenter Prospective Cohort of Essure-related Symptomatology after Removal Surgery

Abstract

Study Objective: Essure is a hysteroscopic sterilization device that has been used in the Netherlands since 2003. Essure has received a lot of publicity due to many reported symptoms associated with the device. Because of this, increasing numbers of patients requested surgical removal of Essure devices. There is still limited data available regarding the effect of removal surgery on reported symptoms and patient satisfaction. The aim of this study was to analyze the effect of Essure removal surgery on reported symptoms and quality of life (QoL). Design: Multicenter prospective study in the Netherlands. Setting: Secondary non-teaching hospitals and secondary and tertiary teaching hospitals. Patients: Patients with Essure-associated symptoms and a request for surgical removal of devices. Interventions: Participants were asked to fill out questionnaires at their first clinic visit and 3 and 12 months after removal surgery. Questionnaires included questions regarding patient characteristics, symptoms, and QoL (SF-36). Clinicians also filled in 2 questionnaires regarding peroperative findings, the removal surgery, and post-operative recovery. Measurements and Main Results: A total of, 1248 patients in 32 hospitals were included in the period between May 2016 and April 2019. Mean age was 42.9 years (25–63 years). Most frequent reported symptoms were mood swings (72.4%), fatigue (71.8%), pain in hips, legs, or groins (68.3%) and abdominal pain (62.3%). Essure was predominantly removed by laparoscopic salpingectomy (87.3%). Mean follow-up time was 17 months (± 10.8). 3 and 12 months after removal surgery, all reported symptoms significantly improved. QoL improved significantly in all 9 domains. Conclusion: Essure removal surgery was associated with improvement in reported symptoms and QoL. Patients presenting with Essure-related symptoms, should be offered Essure removal surgery, after considering the patient-specific risks for surgery.