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 - 01/06/20

Doi : 10.1016/j.jogoh.2020.101781

Margaux Jegaden ^a, Anne-Gaëlle Pourcelot ^a, Hervé Fernandez ^a,^b,^c, Perrine Capmas ^a,^b,^c,⁎
^a AP-HP, GHU-Sud, Hospital Bicêtre, Department of Gynecology and Obstetrics, 78 rue du Général Leclerc, 94270 Le Kremlin Bicêtre, France
^b Faculty of Medicine, University Paris-Sud Saclay, 63 rue Gabriel Péri, 94270 Le Kremlin Bicêtre, France
^c INSERM, U1018, Centre of Research in Epidemiology and Population Health (CESP), 82 rue du Général Leclerc, 94270 Le Kremlin Bicêtre, France

^⁎Corresponding author at: Gynecologic Department, Bicetre hospital, 78 avenue du General Leclerc, 94275 Le Kremlin Bicetre, France.Gynecologic DepartmentBicetre hospital78 avenue du General LeclercLe Kremlin Bicetre94275France

Sous presse. Manuscrit accepté. Disponible en ligne depuis le Monday 01 June 2020
Cet article a été publié dans un numéro de la revue, cliquez ici pour y accéder

Highlights

•	Significant improvement in gynecological and extra-gynecological symptoms over time.
•	No difference in extragynecologic symptom resolution between salpingectomy with cornuectomy and vaginal hysterectomy.
•	Warn patients that some extra-gynecological symptoms may persist after Essure® removal.
•	Improvement in symptoms in the vast majority of patients encourages access to requests for Essure® removal in symptomatic patients.

Le texte complet de cet article est disponible en PDF.

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.

Le texte complet de cet article est disponible en PDF.

Abbreviations : MI, FDA, MAUDE

Keywords : Essure^®, Micro insert removal surgery, Surgical outcomes, Symptoms resolution, Vaginal hysterectomy, Salpingectomy