Improvement of Symptoms After Removal of the Essure® Contraceptive Implant

Launched by HOSPICES CIVILS DE LYON · Apr 3, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how removing the Essure® contraceptive implant might improve symptoms in women who have experienced complications from this device. Essure® was designed for permanent birth control but has caused various health issues for some women since its introduction. The trial aims to gather more information on how removal of the implant can help relieve these symptoms and improve the quality of life for women affected by it.

To be eligible for this study, women aged 35 to 75 who have at least one Essure® implant and are experiencing symptoms can participate. They must be planning to have the implant removed through a specific surgical method, like laparoscopic surgery or another minimally invasive technique. Participants will receive care and monitoring throughout the process, and the study will also explore the biological effects of the implants and the best ways to safely remove them. It’s important to note that only women with symptoms are invited to join, as the trial focuses on those who may benefit from the explantation.

Gender

FEMALE

Eligibility criteria

• * Inclusion Criteria \* :
• ESSURE Group:
• • woman aged 35 to 75
• • patient with at least one Essure® implant
• • surgical intervention planned because the patient is symptomatic: removal of the Essure® implant(s)
• • planned intervention via vaginal route, laparoscopy, robotic surgery, or Transvaginal natural orifice transluminal endoscopic surgery (VNotes)
• • patient having given free, informed and signed consent
• Selection for MRI-PET examination:
• • if the answer is "poor" or "bad" to the first question of the SF-12 pre-operatively
• • no hysterectomy
• • no analgesic treatment, or treatment stopped 48 hours before the examination
• • no psychotropic treatment (anxiolytics, hypnotics (sleeping pills), antidepressants, mood stabilizers, neuroleptics)
• • patient having given free, informed and signed consent
• Control group:
• • woman aged 35 to 75
• • planned surgical intervention: salpingectomy with or without hysterectomy for benign indication
• • planned intervention via vaginal route, laparoscopy, robotic surgery, or VNotes
• • patient having given free, informed and signed consent
• Selection for MRI-PET examination:
• • age matching (+/- 5 years) with Essure® patients who have had an MRI-PET
• • matching on surgical technique with Essure® patients who have had an MRI-PET: salpingectomy with or without hysterectomy
• • no analgesic treatment, or treatment stopped 48 hours before the examination
• • no psychotropic treatment (anxiolytics, hypnotics (sleeping pills), antidepressants, mood stabilizers, neuroleptics)
• • patient having given free, informed and signed consent
• * Exclusion Criteria \* :
• ESSURE Group:
• • asymptomatic patient
• • planned intervention by laparotomy
• • patient potentially exposed to other heavy metals: wearer of metallic orthopedic equipment (hip or knee prosthesis, etc.), wearer of coronary stent, or tubal ligation clip
• • inability to understand the information given
• • persons deprived of liberty by a judicial or administrative decision
• • people undergoing psychiatric care
• • people admitted to a health or social establishment for purposes other than research
• • adults subject to a legal protection measure (guardianship, curatorship)
• • people not affiliated to a social security scheme or beneficiaries of a similar scheme
• • person participating in another interventional research that may interfere with the research
• Selection for MRI-PET examination:
• • claustrophobia
• • dosimetry of all radiological examinations over the past year not acceptable
• Control Group :
• • current pregnancy
• • patient with cancer
• • patient who has already had an Essure® implant removed
• • patient potentially exposed to heavy metals: wearer of metallic orthopedic equipment (hip or knee prosthesis, etc.), wearer of coronary stent, or tubal ligation clip
• • planned intervention by laparotomy
• • inability to understand the information given
• • persons deprived of liberty by a judicial or administrative decision
• • people undergoing psychiatric care
• • people admitted to a health or social establishment for purposes other than research
• • adults subject to a legal protection measure (guardianship, curatorship)
• • people not affiliated to a social security scheme or beneficiaries of a similar scheme
• • person participating in another interventional research that may interfere with the research
• Selection for MRI-PET examination:
• • claustrophobia
• • dosimetry of all radiological examinations over the past year not acceptable