Surgical removal of essure® micro inserts by vaginal hysterectomy or laparoscopic salpingectomy with cornuectomy: Case series and follow up survey about device-attributed symptoms resolution

Abstract

Introduction: Inserts Essure® were used as a definitive sterilization method from 2001 to 2017. They have been used for more than 750,000 procedures. Gynecological or extra gynaecological adverse events have been reported by patients. The objective of the study is to evaluate the resolution of symptoms attributed to Essure® micro-inserts after surgical removal.

Methods: Monocentric retrospective study. Patients who had surgical removal of Essure® micro-inserts between January 2017 and April 2019 were included. The removal was performed by bilateral salpingectomy with cornuectomy by laparoscopy or vaginal hysterectomy. Symptoms were reported preoperatively, 4-8 weeks after withdrawal (early assessment) and 6-24 months after withdrawal (later assessment).

Results: Ninety patients had a surgical removal of Essure® micro-inserts. Fifty-two vaginal hysterectomies and thirty-five laparoscopic salpingectomies were performed. The main symptoms reported are pelvic pain (70 %), fatigue (66.7 %) and heavy bleeding menstruations (53.3 %). One month after surgery, 46.7 % of patients have a major improvement of symptoms and 51.1 % a partial resolution. The major improvement rate is not significantly different between laparoscopic salpingectomy and vaginal hysterectomy (51.5 % versus 42.3 %) (p = 0.23). At 24 months, results improved with 83.3 % major improvement.

Conclusion: Surgical removal may be effective for treating most women with attributed device symptoms. Vaginal hysterectomy and laparoscopic salpingectomy with cornuectomy seem to have an equivalent rate for the resolution of extra-gynecological symptoms.

Keywords: Essure®; Micro insert removal surgery; Salpingectomy; Surgical outcomes; Symptoms resolution; Vaginal hysterectomy.