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

Contraception Clinical Trial

— prevessure  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03955822
• Other study ID #: PI2018-843-0025
• Status: Completed
• Start date: July 10, 2018
• Est. completion date: January 16, 2019

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 642
• Est. completion date: January 16, 2019
• Est. primary completion date: January 16, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Other:
• Phone survey
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.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients who underwent Essure implant withdrawal	this outcome is evaluated with data of medical files and with a phone survey	between 2002 and day of patient inclusion