Laparoscopic Essure Device Removal

Study Overview
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Brief Summary
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In recent years, several symptoms have been attributed to Essure, including pelvic pain and other general symptoms. Consequently, an increasing number of patients request Essure removal for alleged adverse reactions to the device. Study Objective: To evaluate the quality of life of patients who underwent Essure_ device removal and morbidity of this surgery. Design: Prospective observational cohort study. Setting: Academic hospitals of La Conception, Marseille, and Arnaud-de-Villeneuve, Montpellier, France. Patients: Women who underwent Essure_ device removal by salpingectomy, between February 2017 and August 2018. Methods : The following information have been collected during preoperative clinics: demographic data, medical history, clinical symptoms attributed to the Essure device, time between Essure sterilization and early symptoms, time between the beginning of symptoms and surgical removal. Follow-up visits have benne scheduled at one month and three months post-operation. The evolution of symptoms was collected during the follow-up visit at three months based on clinical reports and a dedicated questionnaire. Evaluation of Quality of life have been evaluated thanks to SF36 and HAD questionnaires. Alle these patients will be contacted by phone call to assess to evolution of symptoms and to complete SF 36 and HAD questionnaires. Hypothesis : Recovery of symptoms due to ESSURE device and improvement of quality of life after surgery.

Official Title
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Essure Removal for Device-attributed Symptoms: Quality of Life Evaluation Before and After Surgical Removal

Conditions
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Contraception

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: age >18 years old symptoms related to ESSURE device salpingectomy for ESSURE removal Exclusion criteria: - Exclusion criteria were failure to perform a complete removal of the Essure and second surgery to remove fragments left behind from a previous procedure.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of quality of life after ESSURE removal | Evaluation of quality of life after ESSURE removal by SF 36 questionnaire Preoperative questionnaires will be collected from medical record. Patients will be contacted by phone call to answer to this questionnaire for the long term follow-up | Preoperative | 
| Evaluation of quality of life after ESSURE removal | Evaluation of quality of life after ESSURE removal by SF 36 questionnaire three-months post-operative questionnaires will be collected from medical record. Patients will be contacted by phone call to answer to this questionnaire for the long term follow-up | three-months post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of morbidity of ESSURE removal | description of per et postoperative complications (patient's medical record and by phone call) | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Essure device removal, Quality of life