Burn Injury Following Noninvasive Radiofrequency Lipolysis: A Rare Complication Highlighting Regulatory and Medico-legal Issues

Abstract

ABSTRACT OBJECTIVES: The escalating demand for nonsurgical body contouring and skin rejuvenation has led to a surge in the use of radiofrequency techniques. Despite their popularity, scientific investigations of devices and parameters remain inadequate, resulting in a lack of evidence-based clinical trials. In this case report, we have highlighted the potential hazards of noninvasive radiofrequency fat reduction by presenting a severe burn case. Our objective was to underscore the importance of scientific rigor in establishing treatment parameters and the need for regulatory oversight in the aesthetic industry. MATERIALS & METHODS: A 47-year-old female underwent radiofrequency therapy at an unregulated aesthetic clinic, resulting in a full-thickness deep tissue burn. We have outlined the patient’s history, treatment details, and subsequent care, emphasizing the absence of medical supervision during the procedure. RESULTS: The patient developed a 6 cm × 6-cm full-thickness burn, necessitating operative management. Despite initial nonoperative measures, the burn progressed, leading to a permanent scar and contour irregularity. CONCLUSIONS: This case highlights the urgent need for improved regulation, training, and safety protocols in the aesthetic industry, especially concerning radiofrequency devices. The Montgomery principle emphasizes the necessity of informed consent, and the complexities of medical device regulations and indemnity considerations warrant increased regulatory oversight. Collaborations among legal experts, regulatory bodies, medical professionals, and nonmedical practitioners are essential to ensure patient safety in an evolving aesthetic landscape.