Clinical Research Directory

Transcutaneous Electrical Neurostimulation After Ablation of Essure®

Sponsor: Hospices Civils de Lyon

Summary

The ESSURE® device 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 Marketed in 2002, ESSURE® contraceptive implants were withdrawn from the French market in 2017 (and worldwide in 2017 and 2018) following the observation in certain patients of polymorphic and non-specific gynecological and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. The hypothesis would be a dissemination of the metallic elements contained in these implants. 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 Scientific Interest Group EPI-PHARE, 198,000 French women have these implants and only 30,000 of them, or 15%, have been explanted. A large number of these patients, presenting symptoms, have not yet been treated for an explant. Although explantation of these implants is now recommended in symptomatic patients, approximately 20 to 30% of these patients remain symptomatic after explantation in the form of fibromyalgia signs. Transcutaneous electrical neurostimulation of the vagus nerve uses a non-invasive portable device that is positioned at ear level for 20 minutes per day and allows painless stimulation of the vagus nerve. This device is indicated in fibromyalgia as a non-drug and non-invasive device. This device (TENS ECO PLUS) is offered in routine practice in the service to still symptomatic patients with fibromyalgia symptoms after explantation of the Essure device. In this study, we wish to evaluate the improvement of the symptoms of these patients.

Official title: Evolution of Symptoms Resistant to Removal of the Essure® Implant After Use of Transcutaneous Electrical Neurostimulation

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