Objectives: Despite the theoretical safety of high-intensity focused ultrasound in rejuvenation, adverse events continue to be reported. This study aimed to elucidate the mechanisms underlying adverse events associated with HIFU treatment.
Materials / method: A nationwide survey was conducted among 1,792 institutions in Japan utilizing HIFU, requesting them to complete a detailed questionnaire on adverse events. To identify patterns, we analyzed differences in adverse events by anatomical site and examined the characteristics of HIFU settings associated with these events. Numerical simulation was conducted to further validate our findings.
Results: A total of 139 valid cases were reported, involving 165 adverse events, as some cases involved multiple occurrences. The adverse events were categorized as follows: burns (n = 61), neuropathy (n = 49), purpura/subcutaneous hemorrhage (n = 19), hyperpigmentation (n = 10), wheals (n = 10), prolonged redness (n = 3, induration (n = 3, scars/hypertrophic scars (n = 2), and edema/swelling (n = 2), floaters (n = 2), cataracts (n = 2), facial spasticity (n = 1), and salivary gland cysts (n = 1).
The most frequently implicated transducer depth for adverse events was 4.5 mm, accounting for 78 cases.
Conclusion: Transducers reaching deeper tissues must avoid areas anatomically at risk, such as nerves, vessels, eyes. Heat generated in the bone may damage adjacent nerves, while reflected and refracted ultrasound waves may refocus and cause burns. To minimize adverse events in HIFU therapy, it is critical to have a thorough understanding of HIFU characteristics, local anatomy, and imaging-based evaluation of subcutaneous tissues.
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