Patient satisfaction following treatment with micro-focused ultrasound with visualization: A retrospective cross-sectional study.
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Microfocused ultrasound with real-time visualization is well established as a safe and effective treatment for noninvasive skin lifting. Ultherapy Prime is an updated treatment with an advanced processor and improved imaging capabilities that uses microfocused ultrasound with real-time visualization technology to stimulate tissue remodeling and tightening to improve skin laxity. As published data on Ultherapy Prime in Asian patients are lacking, we conducted a case series to describe the effectiveness and safety of Ultherapy Prime for noninvasive skin lifting and improvement of skin laxity in Asians. Thirty participants with mild-to-severe sagging on the Merz Aesthetics Scale (MAS) for jawline and neck volume received Ultherapy Prime treatment. Dual-depth treatment with 650 lines or more of microfocused ultrasound was customized to the patients' facial anatomies using the See, Plan, Treat approach and applied to the fibrous and deep dermal layers. Outcomes assessed included the MAS for jawline and neck volume, subject and physician Global Aesthetic Improvement Scale scores, and pain scores. Most participants achieved 1 point or greater improvement in neck volume and jawline using the MAS at day 90, regardless of Fitzpatrick phototypes, age, body mass index, or sex. Global Aesthetic Improvement Scale improvement was reported for all physicians and patients (100%), with ratings varying from improved to very improved and very much improved. Treatment was well tolerated (mean pain score 4.50). A single Ultherapy Prime treatment is associated with clinical improvements in jawline and neck skin laxity and is well tolerated in Asian patients across demographics. Micro-focused ultrasound (MFU) can be used to achieve lifting of the brow, lifting of lax submental and neck areas, improving lines and wrinkles on the décolleté, through delivery of ultrasound on tiny points at different levels of the skin. This induces a wound repair reaction, which can achieve the tension and pulling effect of deep dermis and fascia. The objective of this study was to compare patient-reported outcomes, including pain, erythema, and edema, following treatment with Ultherapy Prime and Ultherapy Legacy. A posttreatment questionnaire was used to collect data on pain, erythema, or edema after treatment with Ultherapy Prime and Ultherapy Legacy. This study included 231 participants who underwent treatment with Ultherapy Legacy and Ultherapy Prime and 92 participants who underwent Ultherapy Prime as first-time treatment. Participants reported significantly less pain, erythema, and edema after treatment with Ultherapy Prime, compared to treatment with Ultherapy Legacy, regardless of whether Ultherapy Prime was performed after Ultherapy Legacy or as first-time treatment. Despite some limitations, e.g., a single-center study performing unblinded treatment of participants, in the absence of a crossover design, participants consistently reported less pain, erythema, and edema after treatment with Ultherapy Prime, supporting its efficacy and safety in nonsurgical facial lifting. However, larger studies in more diverse geographical areas are needed to confirm these findings and rule out the impact of cultural differences on pain perception and expression. Skin quality is a multidimensional concept encompassing four emergent perceptual categories (EPCs): firmness, surface evenness, tone evenness, and glow. Microfocused Ultrasound with Visualization (MFU-V; Ulthera System) is a non-invasive device FDA-cleared for lifting and tightening of the skin in specific areas. Through the generation of thermal coagulation points at defined depths, MFU-V initiates neocollagenesis and elastin remodeling, which may support improvements in features related to overall skin quality. To evaluate clinical and preclinical evidence for the impact of MFU-V across the four EPCs of skin quality, including firmness, surface evenness, tone evenness, and glow. A structured narrative review was conducted across PubMed, Google Scholar, and Cochrane databases. Of 703 unique records screened, 67 studies met inclusion criteria. Eligible studies evaluated MFU-V, alone or in combination, reporting outcomes mapped to one or more EPCs of skin quality. MFU-V demonstrated consistent improvements in firmness (n = 52 studies), including elasticity and tautness, with sustained effects beyond 6 months. Improvements in surface evenness (n = 35) included wrinkle reduction, pore refinement, and scar remodeling. Effects on tone evenness (n = 4) were observed in melasma and erythema models, with good tolerance in Fitzpatrick skin types III-VI. Glow (n = 4) was indirectly supported by improved texture and structure. Combination protocols involving MFU-V and fillers or neuromodulators reported positive outcomes. Adverse events were rare and transient. MFU-V provides a safe and versatile platform for enhancing multiple aspects of skin quality. Its effects are well supported in firmness and texture, with emerging evidence for tone and glow. The integration of EPC-based outcomes may inform individualized treatment planning and future research. Non-surgical aesthetic treatments (NSATs) have gained significant traction over the past two decades, prized for their minimally invasive nature, cost-effectiveness, and rapid outcomes. Yet complications associated with these procedures remain underreported, inadequately studied, and inconsistently regulated, compromising patient safety. This mixed-methods study synthesised global data from 457 peer-reviewed studies, 37,250 media articles, 2.28 million social media posts, and regulatory databases, encompassing 231,475 documented complications. Statistical methodologies, including Cox proportional hazards models, Bayesian hierarchical modelling, and geospatial mapping, were employed to evaluate risk trends. Machine learning algorithms forecasted emerging risks, while sensitivity analyses addressed potential data biases. Dermal fillers accounted for 42% of complications, chiefly granulomas, vascular occlusions, and delayed hypersensitivity reactions. Botulinum toxin A contributed 15% of cases, predominantly mild adverse effects such as headache, ptosis, and bruising. Thread lift procedures were marred by frequent extrusion and infection rates. The safest products were identified as Prabotulinumtoxin A, Juvéderm high-viscosity fillers, Profhilo, APTOS Light Lift, microneedling radiofrequency devices, Ultherapy, and EMFACE, each demonstrating > 85% safety probability. Predictive models highlighted escalating risks linked to unregulated therapies (e.g. exosomes), while geospatial analysis revealed stark regional disparities, with Asia reporting 34% of complications-attributed to medical tourism and variable oversight. While advancements like standardised complication registries and ultrasound-guided techniques herald progress, transformative measures are imperative. These include mandating adverse event reporting, harmonising global regulatory frameworks, and integrating AI-driven surveillance systems. The field must prioritise transparency, rigorous credentialling, and patient-centred ethics to ensure its evolution aligns with uncompromising safety standards. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 . A global survey conducted by The International Society of Aesthetic Plastic Surgery (ISAPS) in 2022 reported 18.8 million non-surgical cosmetic procedures, with women representing 87%. Recent literature has shined a light on the possible implication of female sex hormones on the perception of pain, but the influence of these hormones on pain perception secondary to aesthetic procedures have scarcely been studied. Our study aime