Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas.
Obstet Gynecol. 2023 Jul 1;142(1):147-150. doi: 10.1097/AOG.0000000000005213. Epub 2023 Jun 7.
Radiofrequency ablation (RFA) is a relatively novel, increasingly popular treatment option for leiomyomas. We studied medical device-related reports of leiomyoma RFA devices to determine whether there are emerging device-related issues. The Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was queried from 2012 through November 2022. Sixty unique reports, including adverse events and device malfunctions, were analyzed for both laparoscopic and transcervical RFA devices. Forty-three injury reports were reviewed. The most common adverse event was infection. Of the injury cases, 34.9% required additional surgical intervention. Although the details of each event are limited, these reports highlight the importance of postmarket surveillance of new technologies and the necessity of improving the current system of implementation and monitoring.
射频消融（RFA）是一种相对较新的、越来越受欢迎的子宫肌瘤治疗选择。我们研究了与医疗器械相关的子宫肌瘤 RFA 设备报告，以确定是否存在新出现的与设备相关的问题。我们查询了食品和药物管理局的制造商和用户设施设备体验（MAUDE）数据库，时间范围为 2012 年至 2022 年 11 月。对腹腔镜和经宫颈 RFA 设备的不良事件和设备故障的 60 份独特报告进行了分析。我们审查了 43 份伤害报告。最常见的不良事件是感染。在伤害病例中，34.9%需要额外的手术干预。尽管每个事件的细节都很有限，但这些报告强调了对新技术进行上市后监测的重要性，以及改进当前实施和监测系统的必要性。
