Clinical trial NCT03955822: Essure Permanent Birth Control, Effectiveness and Safety: A French Survey
Official title: Essure Permanent Birth Control, Effectiveness and Safety: A French Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: effectiveness
security
adverse effects
permanent birth control
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 642
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

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.


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

Primary outcomes:
measure: Number of side effects of Essure system for the patient
timeFrame: patients who benefited of Essure implant between 2002 and 2017
Secondary outcomes:
measure: Number of patients who underwent Essure implant withdrawal
timeFrame: between 2002 and day of patient inclusion
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: fabrice sergent, Pr
role: PRINCIPAL_INVESTIGATOR
References: