Radiofrequency Ablation for Treatment of Leiomyomas: Review of the Manufacturer and User Facility Device Experience (MAUDE) Database.

Abstract

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.