NCT03955822

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 642 (actual)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-07-10
• Primary completion: 2019-01-16
• Completion: 2019-01-16
• First posted: 2019-05-20
• Last updated: 2020-07-16

Locations

1 site across 1 country: France