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Adios adipose

Article-Adios adipose

Key iconKey Points

  • High-intensity focused ultrasound is one of the new noninvasive technologies that boasts the ability to dissolve fat
  • However, experts question why this technology has yet to be approved in the US, where the dissolved fat goes, and what the safety issues are

Dr. Rohrich
NATIONAL REPORT — American cosmetic surgeons are curious about new technologies that boast the ability to diminish fat without putting a scalpel to the skin. One such technique, called high-intensity focused ultrasound (HIFU), has been tested in clinical trials in other parts of the world with seemingly successful results, but the U.S. Food and Drug Administration is moving cautiously, waiting for the completion of clinical trials in the United States before approving HIFU devices. Two players in the HIFU arena are LipoSonix, based in Seattle, Wash., and UltraShape Ltd., in Yoqneam, Israel. Both firms are set to embark on clinical trials within the United States in the near term.

Dr. Reed
LipoSonix uses HIFU to spur thermocoagulation of adipose tissue. A transducer delivers energy across the skin surface at a low intensity, but brings the energy to a sharp focus in the subcutaneous fat. UltraShape uses a focused ultrasound therapeutic transducer and an ultrasound imaging transducer. The technology provides real-time feedback to ensure transducer-to-skin contact and energy-efficient delivery to the site of treatment.

TRIAL DATA INTRIGUE Two trials of the UltraShape technology, one a single-treatment controlled study and the other a multiple-treatment trial, have demonstrated both efficacy and patient satisfaction. The single-treatment trial, involving 162 patients in study sites in the United States, England and Japan, treated body areas including the abdomen, flanks and thighs. Study endpoints were circumference reduction and a difference in fat thickness. More than four out of five subjects (82 percent) demonstrated a circumference reduction, reporting a 2-cm average decrease at 28 days, which was sustained at 84 days. The treated patients experienced no serious adverse events, no abnormal blood and urine tests and a normal liver ultrasound. More than three quarters of patients (76 percent) indicated moderate-to-excellent satisfaction with a single treatment.

In vivo and in vitro studies with porcine models have been used to test LipoSonix. In addition, a small human trial of 33 patients in Mexico reported a 95 percent resolution of the treatment site by 18 weeks. Study data indicated that the LipoSonix treatment resulted in no damage to the epidermis, dermis, superficial fat or rectus fascia. The majority of the treatment zone was resorbed by eight to 12 weeks following HIFU. There were no changes to lipid levels or blood count in any of the patients. Aesthetic scales indicated clinically significant improvement one month post-HIFU treatment.

PROMISE BUT QUESTIONS "Both are very innovative technology — very forefront and cutting edge," notes Rod Rohrich, M.D., F.A.C.S., a past president of the American Society of Plastic Surgeons and professor and chair of the Department of Plastic Surgery at the University of Texas Southwestern Medical Center in Dallas. "It [HIFU] will become a reality in the U.S. in the very near future," according to Dr. Rohrich. "We have to show that it is safe and effective. There are still some key questions that remain unanswered, which is why it hasn't been approved for use in the U.S. One is, where does the fat go that is dissolved? Is it broken down? What are the safety issues?" Can HIFU take off inches and, if so, how many treatments are needed to achieve a clinical endpoint? These are still open to debate, but Dr. Rohrich thinks the UltraShape clinical trial data warrants attention. While he doubts that HIFU will supplant liposuction, he believes it may likely find a role as an adjunct to liposuction. "Just like Botox and fillers don't replace traditional facelifts, noninvasive fat removal will not replace traditional liposuction," Dr. Rohrich says. "You need liposuction to remove significant amounts of fat in localized areas of lipodystrophy. This will be good as an enhancer in small areas where there is fat."

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