Safety and tolerability of a focused ultrasound device for treatment of adipose tissue in subjects undergoing abdominoplasty: a placebo-control pilot study.

[BACKGROUND] High-intensity focused ultrasound (HIFU) lipolysis is a noninvasive alternative to existing surgical body-sculpting methods.

[OBJECTIVE] To evaluate the safety, tolerability, and histologic outcome of HIFU lipolysis using a novel device in human subjects.

[METHODS AND MATERIALS] In a single-blind pilot study, six healthy subjects scheduled to undergo abdominoplasty within 4 weeks received HIFU lipolysis on one side of the umbilicus. An identical placebo treatment was given to the contralateral side. Patient evaluation of complications, blood tests, and urine analysis were performed 1, 3, 7, 14, and 28 days after treatment. Excised tissue from the treated areas was sent for histologic review.

[RESULTS] Treatment was well tolerated. Average visual analogue pain scale scores were 3.5 ± 2.3 (range 1-7) and 0.17 ± 0.41 (range 0-1). No major adverse events were documented, and laboratory analysis after HIFU lipolysis was normal. Fat necrosis with infiltration of lymphocytes and macrophages without adjacent tissue damage was documented on histology 2 to 4 weeks after HIFU lipolysis. Damage extent correlated with size of the area treated. No pathologic findings were found on the control side.

[CONCLUSIONS] High-intensity focused ultrasound treatment was well tolerated and safe. Focal damage to target tissue was documented, with adjacent tissues remaining intact.