Prospective Multicenter Study of the Improvement of Symptoms After Removal of the Essure® Contraceptive Implant
Overview
- Phase
- Not Applicable
- Intervention
- blood sample
- Conditions
- Implant Complication
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 444
- Locations
- 20
- Primary Endpoint
- Percentage of patients with improvement in symptoms Percentage of patients with improvement in symptoms
- Status
- Recruiting
- Last Updated
- 19 days ago
Overview
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 Marketed in 2002, ESSURE® contraceptive implants were withdrawn from the French market in 2017 (and worldwide in 2017 and 2018) following the observation in certain patients of polymorphic and non-specific gynecological and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.
Investigators
Eligibility Criteria
Inclusion 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
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
Arms & Interventions
Essure Group
Patients requiring removal of the Essure® contraceptive implant
Intervention: blood sample
Essure Group
Patients requiring removal of the Essure® contraceptive implant
Intervention: urine collection
Essure Group
Patients requiring removal of the Essure® contraceptive implant
Intervention: questionnaire
Control Group
Control patients who should benefit from a salpingectomy with or without hysterectomy for a benign indication
Intervention: Magnetic resonance imaging- Positron Emission Tomography (MRI-PET) examination
Control Group
Control patients who should benefit from a salpingectomy with or without hysterectomy for a benign indication
Intervention: blood sample
Control Group
Control patients who should benefit from a salpingectomy with or without hysterectomy for a benign indication
Intervention: urine collection
Essure Group
Patients requiring removal of the Essure® contraceptive implant
Intervention: Magnetic resonance imaging- Positron Emission Tomography (MRI-PET) examination
Control Group
Control patients who should benefit from a salpingectomy with or without hysterectomy for a benign indication
Intervention: Collection of a lock of hair
Essure Group
Patients requiring removal of the Essure® contraceptive implant
Intervention: Collection of a lock of hair
Control Group
Control patients who should benefit from a salpingectomy with or without hysterectomy for a benign indication
Intervention: questionnaire
Outcomes
Primary Outcomes
Percentage of patients with improvement in symptoms Percentage of patients with improvement in symptoms
Time Frame: At 2 months after surgical intervention (removal of the Essure® contraceptive implant)
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.
Secondary Outcomes
- Fibromyalgia Impact Questionnaire (FIQ) score(up 5 years)
- Multidimensional Fatigue Inventory (MFI)-20 score(up 5 years)
- Visual analog scale (VAS) score(up 5 years)
- visual analog scale (VAS) score(During surgical intervention)
- Questionnaire Douleur St-Antoine (QDSA) score(up 5 years)
- Female Sexual Function Index (FSFI) score(up 5 years)
- characterization of the mechanical behavior of the implant(During surgical intervention)
- determination of the associated mechanical stress levels determination of the associated mechanical stress levels(During surgical intervention)
- Percentage of patients with improvement in symptoms(up 5 years)
- Short Form 12 (SF-12) score(up 5 years)
- Hospital Anxiety and Depression scale (HADS) score(up 5 years)
- Higham questionnaires(up 5 years)
- Duration of the procedure(During surgical intervention)
- Complications(Up to 2 months after the operation)
- quantification of the factors influencing these levels of mechanical stress(During surgical intervention)
- Concentrations of titanium constituting the Essure® implant(up 12 months after surgical intervention)
- Concentrations of nickel constituting the Essure® implant(up 12 months after surgical intervention)
- Concentrations of chromium constituting the Essure® implant(up 12 months after surgical intervention)
- Concentrations of tin constituting the Essure® implant(up 12 months after surgical intervention)
- thermal resistance(During surgical intervention)
- risk of degradation(During surgical intervention)
- Concentrations of molybdenum constituting the Essure® implant(up 12 months after surgical intervention)
- Concentrations of manganese constituting the Essure® implant(up 12 months after surgical intervention)
- concentration of pro-inflammatory cytokines(Up 2 months after surgical intervention)
- analysis of inflammatory pathway mRNAs(Up 2 months after surgical intervention)
- Concentrations of platinum constituting the Essure® implant(up 12 months after surgical intervention)
- Concentrations of iridium constituting the Essure® implant(up 12 months after surgical intervention)
- Concentrations of silver constituting the Essure® implant(up 12 months after surgical intervention)
- Concentrations of iron constituting the Essure® implant(up 12 months after surgical intervention)
- Functional brain functions(up 6 months after Surgical intervention)
- Concentrations of tungsten constituting the Essure® implant(up 12 months after surgical intervention)
- expression profile of miRNAs(Up 2 months after surgical intervention)
- activated T lymphocyte profile(Up 2 months after surgical intervention)
- Percentage of detection of Human Leukocyte Antigen(Up 2 months after surgical intervention)