We fully understand the high expectations for the effect and safety of HIFU therapies. That is why we conducted a thorough and independent analysis of the available scientific publications. When reviewing dozens of clinical studies, we found contradictions and gaps that make it difficult to objectively assess the results. We hope that with this material we will distinguish facts from marketing promises and present the real picture of the proven effects of HIFU therapies.
When analyzing clinical trials of HIFU, similar methodological weaknesses are observed. These challenges limit the ability to uniformly assess the efficacy and safety of the technology.
A large number of studies have been conducted with small numbers of patients (e.g. 15 to 50 people) →. Often they are conducted in only one clinic, which questions the scientific validity and makes the results not applicable to all potential patients.
Much of the data comes from retrospective analyses or non-randomized studies, rather than randomized controlled trials. The latter are considered the „gold standard“ in medicine because they provide the highest level of evidence.
Some studies do not include histopathological evidence (tissue analysis). Histopathology is necessary to confirmed the thermal effect and mechanism of action of HIFU in depth.
Over 90% of the patients in the studies were elderly women, which necessitates the need for additional research focused on men.
The effectiveness of HIFU decreases in patients with excessively loose skin and for those with high Body Mass Index (BMI > 30). Because of this, these groups are often excluded from studies, which limits the applicability of the technology to more severe cases.
Multiple systematic reviews confirm that most existing studies have been conducted on Caucasian and Asian populations. Clinical expert opinions explicitly emphasize that future research should focus on the application of HIFU in different ethnic populations, in order to expand applicability of this non-invasive technology.
A key weakness is the lack of unified protocols, expressed in a large variability of energy settings (Joules), penetration depths and number of treatment lines →. This heterogeneity prevents direct comparison of clinical results and the creation of universally valid guidelines for HIFU/MFU treatment. →
The second challenge is the spread of cheaper, imitation devices ("copycat"), which often do not have peer-reviewed data for safety and efficacy. The lack of real-time visualization and safety mechanisms with these devices increases the risk of inaccurate energy delivery and potential serious adverse events (such as burns or nerve damage) →.
The aesthetic results remain highly dependent on subjective assessment. Multiple and are used different rating scales, including questionnaires assessing self-esteem and personal satisfaction – aspects that are highly individual and subjective.
Some studies have noted that participants may were not sufficiently informed or competent to provide adequate feedback regarding adverse events (AEs) immediately after the procedure. This factor creates a risk of underestimation of side effects in the official literature.
Most tracking is in short-term (up to 90 days) or medium-term (up to 180 days) period. Data on long-term efficacy and durability of results are lacking in a year.
In aesthetic medicine, proving the clinical effectiveness and safety of HIFU procedures, as well as analyzing their long-term impact, requires huge financial investments. The costs are usually covered by the manufacturers themselves (sponsored studies), and this makes the studies largely devoid of objectivity due to conflicts of interest.
Direct financing
It has been established direct financing from manufacturers such as Merz Asia Pacific for the preparation of a number of publications.
Conflict of interest
Study authors are often lecturers, consultants or senior managers of companies like Medicis Technologies Corporation.
Impact on HIFU results
This financial commitment unconsciously influences the interpretation of the data in favor of the sponsor.
Declared independence
The most valuable for objective assessment are the publications that explicitly declare a lack of external funding and absence of conflict of interest. These studies rely entirely on scientific methodology.
Academic/Government support
A small number of studies are supported by government/academic funding (e.g. Tianjin). This type of support usually guarantees greater independence from the commercial interests of producers.
The general conclusions from most clinical studies on HIFU often rely on subjective scales such as GAIS (Global Aesthetic Improvement Scale), which classify effects into categories such as „"significant" or "moderate improvement"“. Against this background, the Ultraformer-MPT study was chosen for detailed examination, because it offers objectivity of the results using 3D scanner analysis (LifeViz Mini) for precise quantitative measurement of HIFU lifting effects in millimeters. This methodology provides scientific evidence, regardless of subjective judgment of doctors or patients. Athe second has declared a lack of financial interest in relation to the content of the article, which gives greater weight to the study's conclusions.
Evaluation of the lifting effect in millimeters (mm) and the patient satisfaction score (GAIS) immediately after the HIFU procedure (Ultraformer-MPT).
Seven zones of the face | Average lift (mm) | Standard deviation (SD) | P-value (Two-sided test) | GAIS |
Neck | 3.55 | 1.3477 | 4.5 0.5 | |
Posterior cheek | 3.38 | 0.943536 | 3.1 0.7 | |
Jawline (Mandible/Jawline) | 3.10 | 0.84871655 | 4.2 0.7 | |
Sagging of the lower jaw (Jowl) | 2.90 | 1.107517 | 4.1 0.8 | |
Malar region | 2.47 | 1.096823 | 3.2 0.7 | |
Crow's feet | 2.25 | 0.677288 | 3.4 0.6 | |
Forehead | 1.24 | 0.586597 | 0.010090151 | 3.9 0.7 |
The study was conducted in one clinic with a total of 50 patients (mean age 45.6 ± 12.3 years, 78% women) who were treated with HIFU (Ultraformer-MPT). It takes data from before and immediately after treatment to assess the lifting effect in seven areas of the face. Although these numerical data for lifting (e.g. 1.24 mm on the forehead or 3.55mm on the neck) seem like small physical changes, they are satisfactory from a scientific point of view, proving real and measurable effect of treatment. Whether these minimal, measurable changes will meet the the high expectations and hopes of patients for a visible lifting and significant facial rejuvenation.
Although HIFU is an effective method for skin tightening in patients with mild to moderate sagging skin, our concern is directed at the quality of the evidence itself. Look for studies that are transparent, well-controlled, and published in reputable journals like PubMed, Embase, Cochrane Library and ClinicalTrials.gov. This is responsible, as many platforms claim efficacy without substantial scientific evidence. When analyzing scientific studies, proceed with caution, as even peer-reviewed literature often has limitations such as lack of standardization of protocols and reliance on subjective assessment methods. Your in-depth knowledge and critical evaluation are key to minimizing the risk of disappointment with HIFU therapy.
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