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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | A questionnaire to evaluate clinical improvement and quality of life after ESSURE removal will be completed by patients at least one month after the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the clinical improvement after the intervention of withdrawal of ESSURE devices | 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). | One day at least one month after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
- Women who underwent ESSURE removal to restore their fertility.
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Women who underwent ESSURE removal between January 2017 and January 2018 in the gynecology department of the Croix Rousse Hospital and the gynecology department of the Lyon Sud Hospital. .
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de gynécologie-Obstétrique - Hôpital de la Croix Rousse | Lyon | 69004 | France | |||
| Service de Gynécologie-Obstétrique - Centre Hospitalier Lyon Sud |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Pierre-Bénite |
| 60495 |
| France |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |