Safety of vaginal erbium laser: A review of 113,000 patients treated in the past 8 years

Abstract

Background: Energy-based devices are becoming a popular option for minimally invasive vaginal procedures. The aim of this study was to obtain information on the frequency of occurrence of adverse effects (AEs) related to vaginal erbium laser (VEL™) treatment.

Materials and methods: The global survey was conducted among practitioners using the non-ablative VEL™ (Fotona, Ljubljana, Slovenia). Users were invited to provide the number of patients treated with VEL™ and the number of observed laser-related AEs.

Results: The survey was conducted from August 2018 to April 2019. Responses from 535 practitioners were collected, with a total of 113,174 patients treated in the period from 2012 to 2019. Out of 535 respondents, 160 (30%) shared detailed information about the indications they treated in a population of 62,727 patients, whereas 188 (35%) respondents provided information on the frequency of AEs observed in their treated population of 43,095 patients. All observed AEs were mild to moderate, transient and appeared with low frequencies.

Conclusions: Minimally invasive thermal-only laser treatment using the non-ablative VEL™ procedures appears to be safe and the incidence of AEs is low.

摘要

背景:以能量为基础的设备正成为阴道微创手术的流行选择。本研究的目的是获得与阴道铒激光(VELTM)治疗相关的不良反应(AEs)发生概率的信息。材料和方法:在使用非消融的阴道铒激光VEL^TM(Fotona, Ljubljana, Slovenia)的从业人员中进行了全球调查。使用VEL™的人员被邀请提供使用VEL^TM治疗的患者数量和观察到的与激光相关的不良反应的数量。结果:调查时间从2018年8月至2019年4月。收集了535名使用VEL™的人员的反馈, 他们从2012年至2019年共治疗113,174名患者。535名受访者中, 160名(30%)分享了他们在62,727名患者中治疗的指征的详细信息, 188名(35%)受访者提供了在其治疗人群43,095名患者中观察到的不良反应的频率的信息。所观察到的不良反应均为轻度至中度、短暂和低频率的。

Keywords:

• Non-ablative
• erbium laser
• gynecology
• vaginal erbium laser
• VEL™
• FotonaSMOOTH^®

Potential conflict of interest

Neža Koron and Zdenko Vizintin are employees of Fotona d.o.o., manufacturer of the medical device used in the study. No potential conflict of interest was reported by other authors.

Source of funding

Nil.