Abstract
BACKGROUND: A new intervention called high-intensity focused ultrasound (HIFU) targets fibroids with high-intensity ultrasound pulses using ultrasound probes. This noninvasive method, which can be carried out with either magnetic resonance imaging or ultrasound guidance, results in immediate coagulated necrosis within a clearly defined area a few millimeters in diameter. METHODS: This systematic review evaluated the safety of HIFU in the treatment of uterine fibroids regardless of site or size. We specifically aimed to determine the incidence of side effects that can occur during and after HIFU. We searched the PubMed, Scopus, ScienceDirect, and Mendeley archive using only the terms HIFU and fibroid. After identifying 1077 studies of different types from 2014 to March 2024, 300 studies were screened and 60 included. RESULTS: According to Society of Interventional Radiology guidelines, class A adverse events (AEs) showed no significant results, and individuals with these AEs required no treatment and had no long-term consequences. Similarly, there were no class B significant results. However, 3943 of 10,204 patients (38%) complained of lower abdominal pain after the procedure, a class B AE, which resolved by analgesics. Further, 153 of 24,700 patients (0.6%) had skin burns, blisters, or nodules, and these issues resolved with conservative treatment. Additionally, 74 of 23,741 patients (0.3%) had hematuria; 882 of 5970 patients (14.7%) had abnormal vaginal discharge; 414 of 23,449 (1.7%) had vaginal bleeding; and 267 of 7598 (3.5%) had leg paresthesia. Major AEs (class C and D) were almost nonexistent, and the incidence of death in our study was zero. CONCLUSION: HIFU ablation of uterine fibroids is generally safe, causing mostly mild side effects and very few severe complications. The relative safety of HIFU compared to other minimally invasive techniques, such as uterine artery embolization, still needs further evaluation.