Northeast Ohio Medical University College of Medicine, Rootstown, OH, USA.
Case Western Reserve University School of Medicine, Cleveland, OH, USA.
J Dermatolog Treat. 2020 Mar;31(2):200-203. doi: 10.1080/09546634.2019.1587148. Epub 2019 Mar 19.
Powered muscle stimulators have been popularized in recent years due to their muscle toning effects. This study aims to describe marketing trends and reporting of adverse effects of powered muscle stimulators. We performed a cross-sectional retrospective analysis of records from the United States FDA database for 510(k) premarket approval of powered muscle stimulators between January 1, 2000 and December 31, 2018. The FDA MAUDE database was reviewed for adverse events reported with device usage. One hundred and seventeen devices received 510(k) premarket approval between 2000 and 2018, with the first approval occurring in 2001. Initially, devices were marketed to assist with muscle toning and strengthening, but more recent indications include the treatment of pain, increased local muscle blood circulation, and prevention of post-surgical venous thrombosis. Thirty-six adverse event reports have been submitted and published in the MAUDE database over the past 10 years by 11% of manufacturers. Powered muscle stimulators are growing increasingly popular amongst consumers and healthcare providers due to their ease of use and perceived esthetic, muscle strength, and pain relief benefits. Additional investigation to determine optimal treatment parameters and potential adverse effects is necessary due to the growing popularity of these devices.
近年来，由于肌肉刺激器具有塑造肌肉的效果，因此受到了广泛的欢迎。本研究旨在描述肌肉刺激器的营销趋势和不良影响报告。我们对美国 FDA 数据库中 2000 年 1 月 1 日至 2018 年 12 月 31 日期间接受 510(k) 上市前批准的动力肌肉刺激器的记录进行了横断面回顾性分析。审查了 FDA MAUDE 数据库中与设备使用相关的不良事件报告。在 2000 年至 2018 年间，有 117 种设备获得了 510(k) 上市前批准，首次批准发生在 2001 年。最初，这些设备被用于辅助肌肉紧致和增强，但最近的适应症包括疼痛治疗、增加局部肌肉血液循环和预防术后静脉血栓形成。在过去的 10 年中，MAUDE 数据库中有 11%的制造商提交并发布了 36 份不良事件报告。由于其易用性以及被认为具有美容、肌肉力量和缓解疼痛的益处，动力肌肉刺激器在消费者和医疗保健提供者中越来越受欢迎。由于这些设备越来越受欢迎，因此有必要进行更多的研究以确定最佳的治疗参数和潜在的不良影响。
