Dutch Nationwide Multicenter prospective cohort of Essure-related symptomatology after removal surgery

Liselotte W Maassen; Danielle M van Gastel; Carolien Am Koks; Judith Af Huirne; Aafke Mh Koning; Giuseppe Cm Graziosi; Linda S Bouma; Erik Ah Knauff; Ingrid Aa Van Zon-Rabelink; Marlies Y Bongers; Sebastiaan Veersema

doi:10.1016/j.jmig.2024.10.024

Dutch Nationwide Multicenter prospective cohort of Essure-related symptomatology after removal surgery

J Minim Invasive Gynecol. 2024 Oct 27:S1553-4650(24)01471-7. doi: 10.1016/j.jmig.2024.10.024. Online ahead of print.

Affiliations

¹ University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands. Electronic address: L.W.Maassen-3@umcutrecht.nl.
² University Maastricht, Researchschool Grow, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands.
³ Máxima Medical Center Veldhoven, De Run 4600, 5504 DB Veldhoven, The Netherlands.
⁴ University Medical Center Amsterdam, location VUmc, and research institute Reproduction and Development, Boelelaan 1117 MB Amsterdam, The Netherlands.
⁵ Amstelland Hospital, Laan van de Helende Meesters 8, 1186 AM, Amstelveen, The Netherlands.
⁶ St Antonius Hospital, Koekoekslaan 1, 3430 EM, Nieuwegein, The Netherlands.
⁷ Tjongerschans Hospital, Thialfweg 44, 8441 PW, Heerenveen, The Netherlands.
⁸ Dijklander Ziekenhuis, Waterlandlaan 250, 1441 RN Purmerend, The Netherlands.
⁹ Medisch Spectrum Twente, Koningstraat 1, 7512 KZ Enschede, The Netherlands.
¹⁰ University Maastricht, Researchschool Grow, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands; Máxima Medical Center Veldhoven, De Run 4600, 5504 DB Veldhoven, The Netherlands.
¹¹ University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands.

PMID: 39471973
DOI: 10.1016/j.jmig.2024.10.024

Abstract

Study objective: Essure is a hysteroscopic sterilization device that has been used in the Netherlands since 2003. Essure has received a lot of publicity due to many reported symptoms associated with the device. Because of this, increasing numbers of patients requested surgical removal of Essure devices. There is still limited data available regarding the effect of removal surgery on reported symptoms and patient satisfaction. The aim of this study was to analyze the effect of Essure removal surgery on reported symptoms and quality of life.

Design: Multicenter prospective study in the Netherlands.

Setting: Secondary non-teaching hospitals and secondary and tertiary teaching hospitals.

Patients: Patients with Essure associated symptoms and a request for surgical removal of devices.

Interventions: Participants were asked to fill out questionnaires at their first clinic visit and 3 and 12 months after removal surgery. Questionnaires included questions regarding patient characteristics, symptoms and quality of life (SF-36). Clinicians also filled in 2 questionnaires, regarding peroperative findings, the removal surgery and post-operative recovery.

Measurements and main results: 1248 patients in 32 hospitals were included in the period between May 2016 and April 2019. Mean age was 42.9 years (25-63 years). Most frequent reported symptoms were mood swings (72.4%), fatigue (71.8%), pain in hips, legs or groins (68.3%) and abdominal pain (62.3%). Essure was predominantly removed by laparoscopic salpingectomy (87.3%). Mean follow-up time was 17 months (± 10.8). 3 and 12 months after removal surgery all reported symptoms significantly improved. Quality of life improved significantly on all 9 domains.

Conclusion: Essure removal surgery was associated with improvement in reported symptoms and quality of life. Patients presenting with Essure related symptoms, should be offered Essure removal surgery, after considering the patient specific risks for surgery.

Keywords: Essure related complaints; Essure removal surgery; Hysteroscopic sterilization.