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.
Disclosures
Did you receive any funding to support your research for this TOPIC?
Yes
Please specify entities (individual, company, society): Health and Labour Sciences Research Grant
Were you provided with any honoraria, payment or other compensation for your work on this study?
No
Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
No
Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No
This work was not supported by any direct or non direct funding. It is under the author's own responsability