Abstract
BACKGROUND: Helium plasma radiofrequency (Renuvion, previously J-Plasma) is a new energy-based device that causes coagulation of the subcutaneous fat. The device has recently received 501(k) clearance by the Food and Drug Administration (FDA) for soft tissue contraction after liposuction. A systematic review has not been previously published. METHODS: An electronic search was undertaken to identify publications describing clinical experience with this technique. The US government clinical trials website and the FDA website were queried. The CMS Open Payments database was accessed to evaluate financial bias. RESULTS: Twenty-five publications contained patient data with sufficient information for tabulation. Treatment areas included the face, neck, female and male breasts, trunk, and extremities, usually in combination with liposuction. Studies typically reported subjective surgeon evaluations of photographs and surveys. None of the studies provided standardized photographs with measurements comparing Renuvion to traditional methods. Measurements on matched photographs of breasts treated with Renuvion did not substantiate the authors' claims. The findings of an ultrasound study of the abdominal fat layer were undermined by incorrect labeling of the tissue planes. Most studies were funded by the manufacturer and most investigators had financial conflicts. Few studies mentioned subcutaneous emphysema. Four case reports described patients who suffered helium-induced pneumothorax, pneumomediastinum, pneumoperitoneum, and pneumomastia. Adverse events reported to the FDA included 15 life-threatening events and 3 fatalities. Full-thickness burns were frequently reported. The number and severity of the adverse events greatly exceeded those reported for radiofrequency and ultrasound devices. DISCUSSION: No evidence supports a claim of skin tightening beyond that which may be achieved using traditional or ultrasonic liposuction. Helium gas may permeate body cavities, with serious repercussions. CONCLUSIONS: Marketing has taken precedence over science and safety considerations. This technology introduces serious safety risks to patients, including death, with no proven compensatory benefit.