Removal of Essure Sterilization Devices: A Retrospective Cohort Study in the Netherlands

Abstract

Study objective: To analyze short-term effectiveness and symptom resolution after surgical removal of Essure (Bayer AG, Leverkusen, Germany) sterilization devices.

Design: A single-center retrospective cohort study (Canadian Task Force classification III).

Setting: A large secondary care teaching hospital in the Netherlands.

Patients: All patients who underwent surgical removal of Essure devices between January 2009 and December 2015.

Interventions: Surgical removal of Essure devices was predominantly performed by laparoscopic surgery. In the majority of patients, Essure devices were removed by performing bilateral salpingectomy (66.6%).

Measurements and main results: Data regarding patient characteristics, symptoms, the insertion procedure, the removal procedure, results of the pathological assessment, and follow-up were extracted from patient files. A total of 93 patients had Essure devices removed in the selected period. The onset of symptoms after Essure sterilization was variable. The most frequently reported symptom was abdominal pain (69.9%) followed by lower back pain and fatigue. Most patients reported multiple symptoms; 39.8% of women reported complete relief of symptoms after removal surgery, whereas 15.1% did not notice any relief in symptoms.

Conclusion: Six weeks after removal surgery, 39.8% of patients reported complete resolution of symptoms. Further research to reported symptoms after Essure sterilization and symptom resolution after removal surgery is necessary to inform both patients and gynecologists in order to make a well-considered decision about taking the risks of (major) surgery and the expected benefits of removal.

Keywords: Essure; Hysteroscopic sterilization; Removal surgery.