Come in on your lunch hour, have a few injections and melt away those stubborn bulges of fat. That promise has made injection lipolysis -- also called lipodissolve and mesotherapy -- one of the fastest-growing cosmetic procedures in the country, with centers sprouting up almost as fast as Starbucks stores. Nevermind that neither the procedure nor the drug cocktail used has FDA approval. Nevermind that Kansas and Nebraska are trying to ban the procedure. Nevermind that the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery do not condone the procedure. Nevermind that the procedure has been banned in Brazil, Canada and England.
People want a better body now.
Driving the demand for a fat-dissolving miracle is the insatiable quest for thinner-ness, a rise in noninvasive cosmetic procedures -- specifically injectables such as Botox and Restylane -- and doctors who want to capitalize on both. ASAPS members reported performing injection lipolysis on nearly 29,000 patients in 2006, six times more than in 2005. Members of this group represent only a small fraction of those doing the procedure, so the numbers are actually much higher. Fig, the largest national provider of lipodissolve, has performed more than 170,000 treatments on 50,000 patients since opening its first center in September 2005. The company now operates 17 body-shaping centers in eight states according to Fig chief development officer Chris Dornfeld. Its newest center, and its first in California, opened in August in Costa Mesa and is adding more than 200 patients each month, he said.
When performing the procedure, doctors -- or, more often, nurses, assistants or aestheticians -- inject PCDC, a mixture of phosphatidylcholine (a chemical found in soybeans) and sodium deoxycholate (derived from cattle bile) into the fat layer under the skin to break it down. They say it's not for the obese but, rather, for normal-weight men and women who want to resolve diet-resistant pockets of fat. Treatments involve a series of six to nine injections every few weeks to the same area, commonly the abdomen, love handles, chin and thighs. Most centers, including Fig, charge around $1,500 per treatment area.
The idea behind injection lipolysis arose in the 1950s in France, where doctors began practicing what was known as mesotherapy, a broad term for injecting substances under the skin. They weren't targeting fat but were injecting different vitamins to treat a variety of ailments. In the late 1960s, doctors in Germany started using PCDC, marketed under the name Lipostabil, intravenously to dissolve fat or lipids in blood, and the drug was approved in Europe for that use but never in the United States.
"PC helps the body carry away fat that's already in the blood," said Keith Leonard, president of Kythera, a biopharmaceutical company researching and developing a PC-free fat-dissolving substance. "There's a lot of legitimate science behind that. We might use PCDC today to lower blood lipid, but we have statins, which work so much better." DC, he said, was added to PC as an organic stabilizer. In the 1980s, doctors in Austria and Italy combined mesotherapy and PCDC and reasoned that if it worked on fat in blood, it might work under the skin. The procedure spread from Europe to Brazil and a few years ago landed in the United States.
But not to universal acclaim.
"The doctors doing this are driving ahead of their headlights," said Los Angeles plastic surgeon Brian Kinney, immediate past president of the Plastic Surgery Educational Foundation of the United States and clinical assistant professor of plastic surgery at USC. "They are practicing way outside the bounds of science, which is why some of us are uncomfortable. There's a lot we don't know about these chemicals, including how they affect nerves, tissue and blood vessels. We don't know what happens to the fat once it's dissolved, whether it enters the bloodstream or the lymphatic system."
Terry Dubrow, a board-certified plastic surgeon and medical director for the Costa Mesa Fig center, said the fat doesn't wind up in the bloodstream, that it and the drug are excreted through "normal metabolic pathways."
Richard D'Amico, assistant clinical professor of plastic surgery at the Mount Sinai School of Medicine in New York City and president of the ASPS, agrees with Kinney. "This is another example of hype and marketing getting ahead of science. Patient safety is at risk." The ASPS doesn't recommend patients undergo these treatments until the drugs' safety and efficacy have been proven, he said.