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

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.

Non-extirpative Treatments for Uterine Myomas: Measuring Success.

OBJECTIVE: To analyze outcomes of nonextirpative treatments for uterine myomas compared with myomectomy. DATA SOURCES: A systematic search of the following databases from inception to January 2020 was performed: Ovid Medline, Embase, PubMed, and Cochrane Controlled Register of Trials. METHODS OF STUDY SELECTION: Two authors reviewed titles and abstracts for relevance, and full articles were obtained and evaluated for inclusion. Studies were included if they compared nonextirpative interventions for uterine myomas to myomectomy and reported at least one outcome of interest. TABULATION, INTEGRATION, AND RESULTS: Of the 2010 articles identified and reviewed, 125 full text articles were reviewed, and 22 were ultimately included in the analysis. Nonextirpative treatments reviewed included uterine artery embolization (UAE; 16 studies, n = 9555 subjects), focused ultrasound (FUS; 4 studies, n = 1516), laparoscopic radiofrequency ablation (RFA; 3 studies, n = 49). UAE, FUS, and laparoscopic RFA groups were compared with patients undergoing myomectomy (n = 34 872, n = 20 677, n = 47 respectively). In comparison with myomectomy, UAE had similar quality of life scores, symptom severity scores, sexual function scores, ovarian function, and miscarriage rates following intervention. There was lower likelihood of conceiving after UAE and a higher rate of reintervention after UAE compared with myomectomy. FUS had similar postprocedure sexual function scores and reintervention rates compared with myomectomy. Laparoscopic RFA had similar quality of life scores, symptom severity scores, sexual function scores, reintervention rates, and pregnancy rates after the procedure compared with myomectomy. CONCLUSION: Nonextirpative treatments for uterine myomas have similar outcomes to myomectomy in multiple domains, with most available evidence comparing UAE with myomectomy.