Condition: Implant Complication · Contraceptive Device; Complications · Sponsor: Hospices Civils de Lyon
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 Marketed in 2002, ESSURE® contraceptive implants were withdrawn from the French market in 2017 (and worldwide in 2017 and 2018) following the observation in certain patients of polymorphic and non-specific gynecological and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, an…
This description comes directly from the study's public registry record.
Gautier Chene, PU,PH · 0472355870 · gautier.chene@chu-lyon.fr
Stéphanie MORET · 0472355878 · stephanie.moret@chu-lyon.fr
Always discuss trial participation with your own doctor first.
| CHU de Angers | Angers, France | Not Yet Recruiting |
| Hôpital Femme Mère Enfant (Hospices Civils de Lyon) | Bron, France | Recruiting |
| Hôpital Bicêtre | Le Kremlin-Bicêtre, France | Not Yet Recruiting |
| Hôpital Jeanne de Flandres | Lille, France | Not Yet Recruiting |
| Hôpital de La Conception | Marseille, France | Not Yet Recruiting |
| Institut Mère Enfant Alix de Champagne, CHU Reims | Reims, France | Not Yet Recruiting |
| CHU de Rouen | Rouen, France | Not Yet Recruiting |
| Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg | Strasbourg, France | Not Yet Recruiting |
| Hôpital Paule de Viguier, CHU de Toulouse | Toulouse, France | Not Yet Recruiting |
| Hôpital André Mignot, Centre Hospitalier de Versailles | Versailles, France | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06355713