Authors’ Response

In response to Dr. Ersek’s question regarding the effects of high-intensity focused ultrasound (HIFU) and the possibility of damage to lipid-containing peripheral nerves and resultant dysesthesias, evidence of collateral injury to peripheral nerves was not observed or reported in porcine or human studies (both of which were published in the May issue of Aesthetic Surgery Journal). Histological examination revealed intact structures in the HIFU treatment field containing extracellular lipids. Additionally, in a randomized, sham-controlled study conducted in the U.S. in 180 patients (in press) evaluating the safety and efficacy of HIFU, there were no reports of sensory alterations.1 Clinically speaking, in more than three years of commercial experience in Canada, the European Union, and elsewhere, there have been no reports of hypesthesia or parethesias with the HIFU device we described. With regard to a cannula-based technique for lipoplasty and its safety and preservation of arterial, nerve, and vein structures, Trott et al evaluated patients undergoing both suction-assisted lipoplasty (SAL) and ultrasonic lipoplasty (UAL) for postoperative sensory changes.2 In this study, both groups (SAL and UAL) developed sensory changes (hypesthesia) following a lipoplasty procedure. It was reported that on average, the SAL-treated areas improved to normal sensation by six weeks postoperatively, whereas UAL-treated areas recovered in approximately 10 weeks. The severity of hypesthesia was not correlated with larger aspiration volumes of longer UAL exposure time per site. At 10 weeks, normal sensation was resolved in 90% of UAL-treated patients and 89% of liposuction patients. Therefore, we believe that HIFU represents a novel approach to noninvasive body sculpting with a safety and efficacy profile similar to traditional liposuction procedures. Results in both porcine and human subjects demonstrated no substantive potential for long-term dysesthesias. Drs. Gadsden and Jewell are paid clinical investigators for Medicis Technologies Corporation, Bothell, WA. Dr. Jewell is also a paid consultant for Allergan, Inc., Irvine, CA; an unpaid consultant for Sound Surgical Technologies LLC, Louisville, CO, Keller Medical, Inc., Stuart, FL, AorTech Medical Devices, USA, Salt Lake City, UT, New Beauty Magazine, Sandow Media, New York, NY; and receives financial support as a clinical investigator for Mentor Worldwide LLC, Santa Barbara, CA, Allergan, Inc., Irvine, CA, Kythera Biopharmaceuticals, Inc., Calabasas, CA, and Excaliard Pharmaceuticals, Inc., Carlsbad, CA.

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