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 Dr. Graivier |
However, he says, "One problem is, what is the Food and Drug Administration clearance actually for with a lot of these devices? If you look at the fine print, most of these devices are cleared for skin tightening and temporary relief of cellulite." Although many companies tout research showing that their devices produce circumferential reductions, he adds, surgeons must be careful in discussing and analyzing body-contouring devices because very few have FDA clearance.
Only the following devices have full FDA approval for body contouring, Dr. Graivier says:- The CoolSculpting procedure (Zeltiq), which uses cryolipolysis and is approved for temporary cellulite reduction, along with providing skin cooling and anesthetic properties;
- The LipoSonix system (Solta Medical), which was recently approved by the FDA for noninvasive waist circumference reduction;
- VelaShape (Syneron), which uses radiofrequency (RF) energy, infrared light, plus vacuum suction and mechanical rollers and is cleared for temporary reduction in thigh circumference and appearance of cellulite;
- Zerona (Erchonia), which uses low-level light therapy (LLLT) and is approved for temporary circumferential reduction in the waist, hips and thighs.
The Zerona device houses five laser diodes in an array to produce light at 635 nm, Dr. Graivier says. "It uses a chemically generated laser energy to affect the lipase portion of the (fat) cell," causing it to deflate. In a 67-patient randomized clinical trial, treated patients experienced an average circumference reduction of approximately 1 inch around the waist (Jackson RF, Dedo DD, Roche GC, et al. Lasers Surg Med. 2009;41(10):799-809).
Additionally, Dr. Graivier says Erchonia has published research that shows that adipocytes function somewhat like endocrine organs. More specifically, he says, adipocytes provide some regulation of energy expenditure.
In a 567-patient cohort study, researchers saw that patients experienced fat reductions in treated and untreated areas (Galic S, Oakhill JS, Steinberg GR. Mol Cell Endocrinol. 2010;316(2):129-139. Epub 2009 Aug 31. Review). "These patients were not put on any special diets or additional treatments," Dr. Graivier says. In the Zerona device's FDA studies, researchers observed reduction or no change in patients' HDL, LDL and total cholesterol levels, he says.
RF CONSIDERATIONS Most other body contouring devices, including other LLLT devices and products that use radiofrequency (RF) or acoustic wave energy, are cleared for skin tightening or temporary cellulite relief, Dr. Graivier says. Most have level II through V evidence behind them showing circumferential reductions in treated areas that last for six months and sometimes up to a year post-treatment. "They usually provide about a 4 cm to 7 cm circumferential reduction, depending on the area treated," he says.
Most RF devices for body contouring require regimens of four to eight treatments, Dr. Graivier says. And evaluating these devices is "like car shopping. When you see these sleek devices, which one do you want to try? I believe they all drive somewhat similarly. Each one has a different story, but they are all getting similar results."
With RF devices, "It's all about the heat," he says. Rather than being chromophore-dependent, these devices work by raising skin temperatures. "The patient can only tolerate skin temperatures of 41 to 43 degrees Celsius, whereas you get necrosis at 46 to 47 degrees Celsius."
For tightening in the dermis, RF devices stimulate fibroblasts and the extracellular matrix to cause immediate shrinkage of collagen and subsequent neocollagenesis/neoelastogenesis, Dr. Graivier says.
