Improvement of Symptoms After Removal of the Essure® Contraceptive Implant (ABLES)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Contraceptive Device; Complications; Implant Complication

Treatments: Biological: urine collection; Biological: blood sample; Device: Magnetic resonance imaging- Positron Emission Tomography (MRI-PET) examination; Biological: Collection of a lock of hair; Other: questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT06355713

2023-A02010-45 (Other Identifier)

69HCL23_0899

Details and patient eligibility

About

ESSURE® is an implantable medical device for definitive and irreversible sterilization indicated for adult women of childbearing age. These implants are inserted into the fallopian tubes by hysteroscopy. Marketed in 2002, ESSURE® contraceptive implants were withdrawn from the French market in 2017 (and worldwide in 2017 and 2018) following the observation in certain patients of polymorphic and non-specific gynecological and extra-gynecological symptoms. Studies with small numbers and short-term follow-up have shown a significant improvement in these symptoms after implant explantation. This constitutes a real public health problem since according to the report of the EPI-PHARE Scientific Interest Group, 198,000 French women have these implants and only 30,000 of them, or 15%, have been explanted, knowing that explantation of ESSURE® implants is recommended only in symptomatic patients. A large number of these patients, presenting symptoms, have not yet been treated for an explant.

The physiopathological mechanism(s) is (are) not yet determined but several arguments are in favor of a dissemination of metallic elements contained in these implants whose accumulation could lead to inflammatory and/or allergic and/or autoimmune phenomena.

Carrying out a prospective study with long-term longitudinal follow-up appears essential to precisely assess the degree of improvement in the symptoms and quality of life of these patients, determine the most appropriate surgical techniques, and understand the pathophysiological mechanisms that may result in the implementation of specific treatments and relevant markers. From a surgical point of view, there is a real risk of fracture of implants whatever the type of intervention performed: study the biomechanical properties of implants with a view to characterizing their behavior to mechanical rupture but also their thermal resistance in an objective manner seems essential to limit the risk of fracture and help to inform the patient about the surgical technique proposed for explantation. From a biological point of view, the dosage of the metallic elements constituting ESSURE® implants and potentially toxic ones could make it possible to objectify the release of these metallic elements in the body. Analysis of pro-inflammatory cytokines, micro-RNAs (miRNA), quantitative analysis of inflammatory pathway messenger ribonucleic acid (mRNAs) (NanoString technology) and analysis of neuroinflammation by functional imaging should make it possible to explore potential pathophysiological mechanisms. This study responds to a significant request from patient associations.

Enrollment: 444 estimated patients

Sex: Female

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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444 participants in 2 patient groups

Essure Group

Experimental group

Description:

Patients requiring removal of the Essure® contraceptive implant

Treatment:

Other: questionnaire

Biological: Collection of a lock of hair

Biological: blood sample

Device: Magnetic resonance imaging- Positron Emission Tomography (MRI-PET) examination

Biological: urine collection

Control Group

Active Comparator group

Description:

Control patients who should benefit from a salpingectomy with or without hysterectomy for a benign indication

Treatment:

Other: questionnaire

Biological: Collection of a lock of hair

Biological: blood sample

Device: Magnetic resonance imaging- Positron Emission Tomography (MRI-PET) examination

Biological: urine collection