Impact of ESSURE Devices Withdrawal on the Symptomatology of Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Quality of Life
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 41
- Locations
- 2
- Primary Endpoint
- Evaluation of the clinical improvement after the intervention of withdrawal of ESSURE devices
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The ESSURE device is a method of permanent contraception, marketed in France since 2005. Multiple side effects have been reported by patients since 2015 and the marketing was stopped in 2017. For several months it was observed an increase in requests for withdrawal of these devices. The principal objective of this study is to evaluate clinical improvement and quality of life after ESSURE removal.
This is a multicenter retrospective descriptive study involving the gynecology department of the Croix Rousse Hospital and the gynecology department of the Lyon Sud Hospital over a period of 1 year (1 January 2017-31 December 2017).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women who underwent ESSURE removal due to suspected adverse effects of the device.
- •Women who agreed to participate in the study
Exclusion Criteria
- •Women who underwent ESSURE removal to restore their fertility.
Outcomes
Primary Outcomes
Evaluation of the clinical improvement after the intervention of withdrawal of ESSURE devices
Time Frame: One day at least one month after the procedure
This evaluation will be carried out thanks to a questionnaire. The 4th question retrospectively identifies the symptoms presented by patients. The proposed list of symptoms was established by reviewing the symptoms most often found in the medical records of the patients included. Question 11 evaluates the variation of each symptom after removal of ESSURE devices through an ordinal scale (total disappearance, significant improvement, poor improvement, no improvement, worsening).