Study of Symptom Improvement After Removal of Essure Contraceptive Implants in Women Aged 35 to 75

What this Trial Is About

Researchers are studying the improvement of symptoms in adult women who have the Essure4 contraceptive implant, which was withdrawn from the market due to reports of various gynecological and other symptoms. This prospective multicenter study aims to assess symptom changes after removal of the implant, understand possible biological mechanisms, and evaluate surgical techniques to reduce complications. The study also investigates potential inflammatory and autoimmune effects linked to metallic elements from the implant. Participants include women with at least one Essure4 implant who need surgical removal due to symptoms, and a control group of women undergoing salpingectomy with or without hysterectomy for benign reasons. Surgeries may use vaginal, laparoscopic, robotic, or VNotes approaches. The study includes a subgroup undergoing MRI-PET scans before and 6 months after surgery to explore neuroinflammation. Blood, urine, and hair samples are collected at various timepoints to assess metal concentrations and inflammatory markers. During the study, participants complete questionnaires assessing symptoms, quality of life, fatigue, anxiety, depression, pain, and sexual function before surgery and periodically for up to 5 years. Researchers will measure symptom improvement at 2 months post-surgery as the primary outcome, with longer-term follow-up to monitor changes and safety. The study also evaluates surgical procedure details, implant mechanical properties, and biological markers to better understand the implants effects and guide future treatments.

Improvement of Symptoms After Removal of the Essure® Contraceptive Implant