The Skinny on Cellulite Treatments
Reprinted from the Wall Street Journal August 19th,2007.

Photo courtesy Mary Stoll/Elemé Medical Inc. SmoothShapes targets the uneven appearance of cellulite.

The market for cellulite-fighting equipment is expected to grow to $200 million a year by 2012 from $80 million last year, forecasts Millennium Research Group Inc. Other technologies, including SmoothShapes from Elemé Medical Inc., have been promoted on television shows including NBC's "Today" and the syndicated "Rachael Ray Show."

The hurdle for Food and Drug Administration approval for such devices is low. The agency determines whether a device temporarily reduces the appearance of cellulite through the use of a mechanical massager, but doesn't evaluate the efficacy of any additional technology. "We do not have any data or information about how long the effect lasts," says Karen Riley, a spokeswoman for the FDA, which has cleared more than a dozen devices for cellulite treatment.

Vic A. Narurkar, director of the Bay Area Laser Institute, a San Francisco cosmetic clinic, says company-sponsored cellulite studies are too small and poorly designed to persuade him to invest in a costly technology, or to charge patients for it. Dr. Weiss of the dermatologic society says such studies often rely on photographic comparisons that accentuate the contrast between "before" and "after" pictures.

Many studies also are performed by investigators with financial ties to a manufacturer. Elemé Medical, for instance, says its "pivotal" study of 74 people was conducted by Elliot Lach, a plastic surgeon. But Dr. Lach is also the device's inventor and holds an equity stake in Elemé.

Dr. Lach defends SmoothShapes, which has a list price of $79,900, but says he understands the skepticism. He says he has submitted his study to a medical journal, but it hasn't yet been accepted for publication. The study contains evidence of cellulite reduction that is documented with magnetic resonance imaging, a more authoritative measure of results than photographs, he says.

Elemé hopes to convince skeptics with a broader study of 200 or more subjects at multiple clinical sites. It says the photography is being carefully handled to maximize its credibility with independent reviewers.