Long-term effectiveness of surgical removal of Essure® implants: A retrospective cohort study

Abstract

Study objective: To assess symptom resolution and patient satisfaction following surgical explantation of Essure implants in the short and long term.

Design: Retrospective monocentric cohort study (Lille Regional University Hospital, France).

Setting: Essure is an implantable medical device for definitive sterilisation. Available from 2002, the Essure device has no longer been marketed since 2017. Following numerous reported side effects, the number of requests to withdraw Essure has steadily increased in recent years.

Patients: All women who underwent Essure removal between December 2016 and January 2020 to assess the benefits of surgery on these symptoms and patient satisfaction at 6 weeks and 6 months after the procedure.

Interventions: Removal of Essure implant with 4 types of surgery.

Measurements: The benefits of the surgery were assessed using data from the postoperative consultation 6 to 8 weeks after surgery and then from a telephone call 6 months after surgery.

Main results: 86 patients were explanted during the study period. Surgery proved beneficial, with a complete reduction in symptoms at 6 months in 74 % of these patients. Many symptoms were relieved by surgery, with complete resolution of symptoms in 62 % of cases for muscle pain, in 69 % of cases for asthenia, in 82 % of cases for abdominal pain and 100 % of cases for menorrhagia. Patient satisfaction was high, with 97.3 % of patients willing to repeat the procedure and 95.95 % recommending it to a friend.

Conclusion: Removal of Essure implants in symptomatic patients appears to reduce all symptoms and improve quality of life in short and long term. Nevertheless, there are many symptoms associated with the insertion of Essure implants, and although surgery appears beneficial with good patient compliance, some adverse effects persist. It is therefore important to carry out a pre-operative etiological assessment and provide information on the risk of surgical failure.

Keywords: Adverse effects; Cornuectomy; Essure; Hysterectomy removal.