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

NCT03955822 | Completed

• 1 other identifier: PI2018-843-0025
• Study Type: observational
• Target: 642
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Keywords

effectiveness; security; adverse effects; permanent birth control

Outcome Measures

Primary Outcomes (1)

• Number of side effects of Essure system for the patient

  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.

  patients who benefited of Essure implant between 2002 and 2017

Secondary Outcomes (1)

• Number of patients who underwent Essure implant withdrawal

  between 2002 and day of patient inclusion

Interventions

Phone survey OTHER

Phone Survey in order to evaluate adverse effect of the permanently implanted birth control device for women (Essure) will be proposed to wmen Treated between 2002 and 2017 with Essure.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women who underwent volontary sterilization with the Essure implant
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who underwent volontary sterilization with the Essure permanent birth control in CHU Amiens between 2002 and 2017

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

Study Officials

• fabrice sergent, Pr

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 20, 2019
• Study Start: July 10, 2018
• Primary Completion: January 16, 2019
• Study Completion: January 16, 2019
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)