Impact of ESSURE Devices Withdrawal on the Symptomatology of Patients (ESSURE)

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).

Study Overview

• Status: Completed
• Conditions: Quality of Life; Contraceptive Device; Complications
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Service de gynécologie-Obstétrique - Hôpital de la Croix Rousse
  • Pierre-Bénite, France, 60495
    • Service de gynécologie-obstétrique - Centre hospitalier Lyon sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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. .

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2018
• Primary Completion (Actual): September 3, 2018
• Study Completion (Actual): September 3, 2018

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 69HCL18_0160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No