Quality of life after laparoscopic removal of Essure® sterilization devices

Abstract

Objective(s) To assess changes in quality of life after laparoscopic removal of Essure ® sterilization 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 Essure ® sterilization devices undergoing subsequent surgical removal were included. Laparoscopic removal of Essure ® 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 Essure ® device removal. Planned procedures were all successfully completed. Conclusion Laparoscopic removal of Essure® 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.

Potential release of toxic metal elements from Essure® device in symptomatic patients: First results of the French Ablimco cohort

“…It is not certain that these potential toxic metals are necessarily responsible for the adverse effects. As a result, there are no indications to date to remove implants to all patients, especially in case of non-symptomatic patients [1]. In symptomatic patients, there are also no biological or clinical arguments to prefer hysterectomy with salpingectomy rather than laparoscopic conservative procedure (salpingectomy with traction on the implant or salpingectomy with mini-cornuectomy) [1].…”

“…Since the decision to halt sales of the Essure® implants for permanent birth control in December 2018 (Bayer©, Leverkusen, Germany), many patients have complained of unspecific symptoms, such as gynecological disorders (pain, menorrhagia), but also broad extrapelvic symptoms (persistent asthenia and fatigue, heart palpitations, tinnitus, pruritus, joint and / or muscularis pain, skin rashes, digestive disorders) [1]. Several studies have shown an improvement in symptomatology and quality of life after Essure® removal in symptomatic patients [1,2]. The question arises as to what is the pathophysiology of these local and systemic adverse events.…”

Best practices for evaluating pelvic pain in patients with Essure tubal occlusion devices

“…Results suggest that the incision and traction method poses more technical difficulties than the cornuectomy approach. 23 Surgeons reported significant difficulty controlling the tensile pressure with traction, whereas use of the cornuectomy approach eliminated this risk and decreased the risk of fragmentation and incomplete removal. 23,24 Charavil and colleagues demonstrated in a prospective observational study that a vaginal hysterectomy with bilateral salpingectomy is a feasible approach to Essure removal.…”

Essure^® removal in 10 steps

“…Several studies have demonstrated an improvement of symptomatology and quality of life after removal of the Essure ® device in symptomatic patients ( 1 , 2 ). The pathophysiology of adverse effects related to the device may be explained by the release of heavy metals from a possible corrosion of the implant ( 3 ).…”

“…The pathophysiology of adverse effects related to the device may be explained by the release of heavy metals from a possible corrosion of the implant ( 3 ). Therefore, because there is a risk of fracture in up to 30% of cases ( 2 ), the implant should be removed completely and safely ( 4 ). Our aim was to give a step-by-step description of an easy surgical technique with a demonstrative video.…”