Thursday, October 11, 2007

Lipodissolve




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 Rockville, Md., plastic surgeon Roger Friedman. “Liposuction is pounds, not inches.” Recovery is quicker after lipodissolve, Friedman says. 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. “I’ve always said to my husband that for my 50th birthday, I want two things,” Promisloff, 49, says. “I want long-term care insurance, and I want a tummy tuck.”

Her husband can cross off tummy tuck. Promisloff now wears low-slung jeans to show off her newly flat stomach. Yet a scalpel never touched her abdomen. Promisloff swears by an increasingly popular and controversial treatment called lipodissolve, touted as a non-surgical alternative to liposuction.

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.

Lipodissolve practitioners inject small amounts of a chemical found in lecithin — better known as a food ingredient derived from soybeans — into pesky protrusions of pudge, aka love handles, muffin tops and bra rolls.

Kansas moves to ban procedure

Promisloff, of Rockville, Md., 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.

Another satisfied customer, Jodi Kusick, 62, says “it kind of bothered me that it had been going on in other countries, but the FDA doesn’t approve it yet.” Still, Kusick, of Safford, Ariz., has periodically been making seven-hour round trips to Scottsdale for lipodissolve shots in her abdomen at Fig (for figure), one of a chain of centers based in St. Louis.

In a few days, lipodissolve 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.

Fig sought a temporary injunction, but the court did not reach a decision at a hearing Monday, says Mark Stafford, general counsel of the healing arts board.

The Kansas board has received complaints from lipodissolve patients of pain, nausea, diarrhea, elevated liver enzymes and lumps at the injection site, Stafford says. He acknowledges it’s impossible to tell whether the side effects stemmed from the shots.

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.

Yet, Kythera Biopharmaceuticals of Calabasas, Calif., 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, N.Y., plastic surgeon Alan Gold, 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.”

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