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Clinical Trials/NCT03955822
NCT03955822
Completed
Not Applicable

Essure Permanent Birth Control, Effectiveness and Safety: A French Survey

Centre Hospitalier Universitaire, Amiens1 site in 1 country642 target enrollmentJuly 10, 2018
ConditionsContraception

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Contraception
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
642
Locations
1
Primary Endpoint
Number of side effects of Essure system for the patient
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Since 2002, in CHU Amiens, Essure implants started to be used for women in need of voluntary sterilization in accordance with French national recommendations. Recently patient committees emerged to alert health agency and governments about various symptoms possibly link to the Essure implants. New studies have been launched in order to determinate if Essure implants were involved with the symptoms described. According to the scientific literature no solid link between Essure and the symptomatology was highlighted. French National College of Gynecologists and Obstetricians send a letter of information for patient and gynecologists. French National agency of medicament suspended Essure authorization in august 2017 for 3 months. Bayer industry decided to withdraw from the market the Essure implants in autumn 2017. Currently Essure procedures have been stopped to be used in CHU Amiens since august 2017. But, in CHU Amiens, health institutions still have to manage patients with Essure implants and potential adverse effects.

The purpose of this study is to determine if the patients treated between 2002 and 2017 with Essure implant present complications, had a proper follow up after the Essure implantation, and that the Essure implantation respected the medical guidelines in order to offer the best medical care with these new informations.

Medical data from patients who received Essure procedure will be collected with medical file and a survey about adverse effects will be submitted to patients by phone if they agree to take part of the study after loyal information.

Registry
clinicaltrials.gov
Start Date
July 10, 2018
End Date
January 16, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • women more than 18 years old
  • patients who benefit of Essure permanent birth control in CHU Amiens between 2002 and 2017
  • signed informed consent form

Exclusion Criteria

  • women Under 18 years old
  • refusal to participate
  • patient Under administrative supervision

Outcomes

Primary Outcomes

Number of side effects of Essure system for the patient

Time Frame: patients who benefited of Essure implant between 2002 and 2017

this outcome is evaluated with data of medical files and with a phone survey submitted to the patient who had the essure procedure in CHU Amiens.

Secondary Outcomes

  • Number of patients who underwent Essure implant withdrawal(between 2002 and day of patient inclusion)

Study Sites (1)

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