Microfocused Ultrasound With Visualization (MFU-V) Effectiveness and Safety: A Systematic Review and Meta-Analysis

Abstract

Microfocused ultrasound with visualization (MFU-V) is an advanced, noninvasive cosmetic procedure widely performed for skin lifting and tightening. We performed a systematic review and meta-analysis to evaluate the aesthetic effectiveness, patient satisfaction, skin quality, and safety profile of MFU-V treatment. A comprehensive search of 5 bibliographic databases up to 2023 was conducted. Pooled effect estimates with random effects models and corresponding 95% confidence intervals were calculated. Out of 4019 references, 42 studies were included. Meta-analysis showed 89% of patients (95% CI: 81%-94%; I2: 63%, n = 411) demonstrated some degree of global aesthetic improvement, as assessed by investigators. Similarly, 84% of patients (95% CI: 73%-91%; I2: 64%, n = 312) reported improvement following treatment. Satisfaction of any level was reported by 84% of patients (95% CI: 61%-94%; I²: 52%, n = 326), and 62% (95% CI: 37%-82%; I²: 3%, n = 172) when "neutral" as a response option was provided for patients. Skin quality (eg, wrinkles, texture) also improved. Patients reported a pooled mean pain score of 4.85 (95% CI: 4.35, 5.35; I2: 97%, n = 785), indicating moderate pain. Common adverse events included erythema, edema, swelling, bruising, and tenderness, all of which were generally mild to moderate in severity. Overall, our analysis demonstrated a notable increase in global aesthetic improvement and patient satisfaction following MFU-V treatment, accompanied by moderate pain and a generally favorable safety profile. However, the potential misclassification of neutral responses as positive may result in an overestimation of the treatment's efficacy. These findings highlight the need for well-designed trials to further explore MFU-V's clinical applications.

Figure 1.

Flowchart of identification, screening, eligibility, inclusion, and exclusion of retrieved studies.

Figure 2.

Risk of bias summary of (A) included nonrandomized studies using risk of bias in nonrandomized studies (ROBINS-I) and (B) randomized controlled studies using Cochrane Collaboration's Tool Risk of Bias 2 (ROB2). The shaded regions in (A) indicate “no information” for assessing the corresponding domain in certain studies.

Figure 3.

Summary proportions and pooled estimates of (A) investigator global aesthetic improvement, (B) patient global aesthetic improvement, (C) patient satisfaction, and (D) pain following MFU-V treatment. MFU-V, microfocused ultrasound with visualization.

Figure 4.

Summary proportions and pooled estimates of (A) investigator global aesthetic improvement, (B) patient global aesthetic improvement, (C) patient satisfaction, and (D) pain following MFU-V treatment per treated site. MFU-V, microfocused ultrasound with visualization.

Figure 4.

Summary proportions and pooled estimates of (A) investigator global aesthetic improvement, (B) patient global aesthetic improvement, (C) patient satisfaction, and (D) pain following MFU-V treatment per treated site. MFU-V, microfocused ultrasound with visualization.