The American Society of Non-surgical Aesthetics, a trade group, estimates that 50,000 to 100,000 lipodissolve treatments have been performed in the USA and Europe. That's nothing compared with the 300,000 liposuction procedures performed last year in the USA, but the lipodissolve group predicts its U.S. market will grow to 500,000 a year.
The obvious difference between liposuction and lipodissolve is that the former is a surgical procedure; the latter, which involves a series of injections, is not. Plastic surgeons who do both say people who want just a bit of body contouring are lipodissolve candidates, while those who want to lose bigger fat deposits probably need liposuction. "Lipodissolve is inches, not pounds," says Maryland plastic surgeon Roger Friedman. "Liposuction is pounds, not inches." Recovery is quicker after lipodissolve, Friedman says.
Lipodissolve practitioners inject small amounts of a chemical found in lecithin better known as a food ingredient derived from soybeans.
But phosphatidylcholine deoxycholate, the compound generally used in lipodissolve shots, isn't Food and Drug Administration-approved, so safety and effectiveness questions remain, to wit, if the fat cells are dissolved, where do they go?
Lipodissolve proponents say it is safer than liposuction because it eliminates surgical risks. They say that fat cells eradicated by lipodissolve migrate to the liver and then are excreted naturally. But skeptics note a lack of studies about lipodissolve's safety.
Promisloff, of Rockville, Maryland says she did her homework before signing up in January at one of two Washington, D.C.-area MedSculpt centers. "The FDA thing didn't bother me at all," says Promisloff, who works in marketing and advertising sales. "They've been doing it in Europe for however long. There have been no cases of death or sickness or anything that would have dissuaded me." She says she spent $2,500 to $3,000 on four treatment sessions and plans more, this time for her flabby flanks.
Lpodissolve might not be in Kansas anymore, except in clinical trials. On Aug. 18, the State Board of Healing Arts, which regulates Kansas doctors, became the nation's first to ban marketing and sales of lipodissolve, which was to go into effect this Friday. The Physicians Coalition for Injectable Safety, formed by three plastic surgery groups, supports the move.
The Board has received complaints from lipodissolve patients of pain, nausea, diarrhea, elevated liver enzymes and lumps at the injection site, the board's counsel Mark Stafford says. He acknowledges it's impossible to tell whether the side effects stemmed from the shots.
That's the problem, he says: "We don't know much about this product, because it has not been clinically studied. There might be some longer-range problems, but again, we don't know. If this product is as effective and safe as its proponents say, then let's have some clinical research."
The non-surgical aesthetics group says lipodissolve isn't a drug but a treatment, and treatments aren't FDA-regulated. And, proponents note, compounding pharmacists, who don't need FDA approval, make lipodissolve.
The FDA disagrees. "These are unapproved drugs for unapproved uses," spokeswoman Karen Riley said in an e-mail, noting the FDA is "investigating and evaluating" lipodissolve. Meanwhile, she said, "Consumers need to know that this is a buyer-beware situation."
So far, though, the FDA has issued only one warning letter about lipodissolve, in 2003, to Ayoula Dublin in New York City. Dublin's website marketed phosphatidylcholine injections to "burn fat away," the letter said. The site claimed the shots were a nutritional supplement not regulated by the FDA. But supplements are swallowed, not injected, the FDA said, calling Dublin's product an unapproved new drug.
Dublin now sells lipodissolve pills. A check Monday of Dublin's website found this pitch: "These tablets contain the same active ingredients as the liquid injectable form that is applied to your problem areas. Instead of localized fat removal, you will get a complete body makeover." Messages to the website's phone number and e-mail address went unanswered.
Practitioners say they can't afford the clinical trials the FDA requires. "It's a multimillion-dollar thing to get something through the FDA," says Roger Friedman, quoted earlier.
But Kythera Biopharmaceuticals of Calabasas, California, recently announced that it is conducting clinical trials to win FDA approval for an injectable to trim double chins. And the Aesthetic Surgery Education and Research Foundation just received FDA permission to conduct a 20-patient trial comparing lipodissolve with placebo shots.
"While this does sound almost too good to be true," says Great Neck, foundation president and president-elect of the American Society for Aesthetic Plastic Surgery, "hopefully this turns out to be something that is safe and effective for our patients."