Quality of life after laparoscopic removal of Essure1 sterilization devices

Abstract

Quality of life after laparoscopic removal of Essure1 sterilization devices Gautier Chenea,b,*, Emanuele Cerrutoa, Stephanie Moreta, Karine Lebail-Carvala, Philippe Chaberta, Georges Melliera, Erdogan Nohuza, Gery Lamblina, T. Justin Clarkc a Department of Gynecology, Hôpital Femme Mère Enfant, HFME, 59 boulevard Pinel, Universitary hospital of Lyon, 69000 Lyon, France b Claude Bernard University of Lyon 1, EMR 3738, 69000 Lyon, France c Department of Obstetrics and Gynaecology, Birmingham Women's and Children’s Hospital, Birmingham, B15 2TG, UK A R T I C L E I N F O Article history: Received 19 April 2019 Received in revised form 11 May 2019 Accepted 19 May 2019 Available online 20 May 2019 Keywords: Essure1 removal Hysteroscopic sterilization Laparoscopy Quality of life Salpingectomy A B S T R A C T Objective(s): To assess changes in quality of life after laparoscopic removal of Essure1sterilization devices (Bayer AG, Leverkusen, Germany). Study Design: In this prospective observational study in an academic research hospital, 80 women with new or worsening symptoms since placement of Essure1 sterilization devices undergoing subsequent surgical removal were included. Laparoscopic removal of Essure1 devices and salpingectomy with or without cornual excision were performed. Concomitant uterine procedures could be associated where indicated for gynaecological complaints. Comparison using the T student test for coupled series was done in this before-and-after study. Results: Health related quality of life (HRQL) was the primary outcome measured by the Short Form 12 (SF-12) questionnaire and a global 10 cm visual analogue scale (VAS). Secondary outcomes included assessment of pain, using continuous (VAS) and ordinal scales (Modified McGill Pain Questionnaire), menstrual bleeding (pictorial blood loss assessment chart (PBAC) score) and surgical feasibility and safety. There was a significant improvement in quality of life in both mental and physical health aspects of the SF-12 (34.02 (+/ 1.19) vs. 49.61 (+/ 1.42, P < .0001) and 36.55 (+/ 0.99) vs. 43.32 (+/ 1.18, P < .0001 respectively) as well as global VAS assessment (+2.91 (SD +/ 0.27)) at the end of the first post-operative month. These improvements were maintained at three and six months. Mean pain decreased at one month following surgery compared to baseline (VAS 3.6 (+/ 0.36) to 1.4 (+/ 0.25), P < .0001 and McGill pain score 18.70 (+/ 1.88) to 4.73 (+/ 0.90), P < .0001). Improvements of a similar magnitude were observed when analysis was restricted to the 47 women without concomitant uterine surgery. No significant changes in bleeding were seen following of Essure1 device removal. Planned procedures were all successfully completed. Conclusion: Laparoscopic removal of Essure1 devices in symptomatic women is technically successful and associated with short and medium-term improvement in quality of life as well as reduction in pelvic pain.