Improvement of Symptoms After Removal of the Essure® Contraceptive Implant
ABLES
Prospective Multicenter Study of the Improvement of Symptoms After Removal of the Essure® Contraceptive Implant
2 other identifiers
interventional
444
1 country
10
Brief Summary
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 Marketed in 2002, ESSURE® contraceptive implants were withdrawn from the French market in 2017 (and worldwide in 2017 and 2018) following the observation in certain patients of polymorphic and non-specific gynecological and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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2025
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2024
CompletedFirst Posted
Study publicly available on registry
April 9, 2024
CompletedStudy Start
First participant enrolled
February 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 17, 2037
April 13, 2026
March 1, 2026
7.2 years
March 28, 2024
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients with improvement in symptoms Percentage of patients with improvement in symptoms
Percentage of patients with a score of 1, 2 or 3 (corresponding to improvement in symptoms) on the Patient Global Impression of Improvement (PGI-I) scale. The PGI-I is a transition scale that is a single question asking the patient to rate their symptoms now, as compared with how it was prior to before beginning treatment on a scale from 1 = Very much better to 7 = Very much worse.
At 2 months after surgical intervention (removal of the Essure® contraceptive implant)
Secondary Outcomes (34)
Percentage of patients with improvement in symptoms
up 5 years
Short Form 12 (SF-12) score
up 5 years
Fibromyalgia Impact Questionnaire (FIQ) score
up 5 years
Hospital Anxiety and Depression scale (HADS) score
up 5 years
Multidimensional Fatigue Inventory (MFI)-20 score
up 5 years
- +29 more secondary outcomes
Study Arms (2)
Essure Group
EXPERIMENTALPatients requiring removal of the Essure® contraceptive implant
Control Group
ACTIVE COMPARATORControl patients who should benefit from a salpingectomy with or without hysterectomy for a benign indication
Interventions
An MRI-PET examination will be carried out pre-operatively and at 6 months for the first 20 patients with Essure® and pre-operatively for the first 10 control patients presenting the selection criteria. The duration of each acquisition will be approximately 2 hours. Upon arrival, participants will be greeted by electroradiography technicians. A venous catheter will be placed in a vein in the right or left arm. Participants will be installed in the hybrid MRI-PET imager. The injection of \[11C\]PK11195 will take place in the MRI-PET acquisition room. Recording of functional neuroimaging data will begin immediately after intravenous injection of \[11C\]PK11195 and will last for 70 minutes in a resting state. At the end of the examination, the venous catheter will be removed and the visit will be over.
Patients with Essure : Blood sample pre-operatively (20 mL) and at 2 months (10 mL) and 12 months (5 mL). Control patients : Blood sample pre-operatively (20 mL)
Patients with Essure : urine collection pre-operatively (10 mL) and at 2 months (10 mL) and 12 months (10 mL). Control patients : urine collection pre-operatively (10 mL)
Patients with Essure : Collection of a lock of hair pre-operatively and at 12 months Control patients : Collection of a lock of hair pre-operatively
Questionnaires pre-operatively (except PGI-I) and at 2, 6, 12 months then twice a year up to 5 years for patients with Essure, and pre-operatively (except PGI-I) and at 2 months for control patients : * PGI-I: symptom improvement score * SF-12: quality of life with physical and mental dimension. * FIQ: quality of life of women with fibromyalgia symptoms * HADS: anxiety and depressive dimension * MFI-20: fatigue according to 5 dimensions ) * VAS : pain assessment * QDSA: assessment of sensory and emotional impact of pain * FSFI : quality of sexual life * Higham score
Eligibility Criteria
You may qualify if:
- 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
- +8 more criteria
You may not qualify if:
- 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 :
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
CHU de Angers
Angers, 49933, France
Hôpital Femme Mère Enfant (Hospices Civils de Lyon)
Bron, 69677, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275, France
Hôpital Jeanne de Flandres
Lille, 59037, France
Hôpital de La Conception
Marseille, 13005, France
Institut Mère Enfant Alix de Champagne, CHU Reims
Reims, 51092, France
CHU de Rouen
Rouen, 76000, France
Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67200, France
Hôpital Paule de Viguier, CHU de Toulouse
Toulouse, 31059, France
Hôpital André Mignot, Centre Hospitalier de Versailles
Versailles, 78157, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2024
First Posted
April 9, 2024
Study Start
February 17, 2025
Primary Completion (Estimated)
April 17, 2032
Study Completion (Estimated)
February 17, 2037
Last Updated
April 13, 2026
Record last verified: 2026-03