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Improvement of Symptoms After Removal of the Essure® Contraceptive Implant
Sponsor: Hospices Civils de Lyon
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 Marketed in 2002, ESSURE® contraceptive implants were withdrawn from the French market in 2017 (and worldwide in 2017 and 2018) following the observation in certain patients of polymorphic and non-specific gynecological and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.
Official title: Prospective Multicenter Study of the Improvement of Symptoms After Removal of the Essure® Contraceptive Implant
Key Details
Gender
FEMALE
Age Range
35 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
444
Start Date
2025-02-17
Completion Date
2037-02-17
Last Updated
2025-03-07
Healthy Volunteers
No
Interventions
Magnetic resonance imaging- Positron Emission Tomography (MRI-PET) examination
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.
blood sample
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)
urine collection
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)
Collection of a lock of hair
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
questionnaire
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
Locations (10)
CHU de Angers
Angers, France
Hôpital Femme Mère Enfant (Hospices Civils de Lyon)
Bron, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
Hôpital Jeanne de Flandres
Lille, France
Hôpital de La Conception
Marseille, France
Institut Mère Enfant Alix de Champagne, CHU Reims
Reims, France
CHU de Rouen
Rouen, France
Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Hôpital Paule de Viguier, CHU de Toulouse
Toulouse, France
Hôpital André Mignot, Centre Hospitalier de Versailles
Versailles, France