In the last two years, the cosmetic procedure going by the name lipodissolve has become a household name in Missouri and Kansas.
For those unaware of the term, lipodissolve entails the use of injections of a drug compound to target unwanted fat deposits in areas such as the buttocks, thighs and abdomen.
Anti-fat injections are one of the most hotly debated procedures in cosmetic medicine. Lipodissolve in particular involves deeper injections of a compound drug that is supposed to break down cells in the fatty layer under skin. Another such procedure; mesotherapy involves superficially injecting vitamins and other substances into the skin.
Some regulators and local doctors have issued warnings about lipodissolve, arguing that such anti-fat shots lack the kind of rigorous prospective clinical research that would prove their safety and efficacy.
In an effort to collect some hard data, Dr. V. Leroy Young, a plastic surgeon, says he has just received permission from the F.D.A. to conduct a small clinical study of one of the drug mixtures. In Kansas, the board of medicine last month tried to ban injections of the same drug compound after receiving complaints from consumers, but a judge last week stayed the restrictions after a petition from lipodissolve providers. "These are unapproved drugs for unapproved uses and we can't guarantee consumers' safety," warns Karen Riley, an F.D.A. spokeswoman.
Anti-fat shots often contain a compound of approved drug ingredients known as PCDC, which includes a phospholipid called phosphatidylcholine and a bile acid called deoxycholate. A drug containing PCDC called Lipostabil is approved in Germany as an intravenous medication to treat blood vessels blocked by fat embolisms. In Britain, where the drug is not licensed, it has been marketed for cosmetic anti-fat injections under the name Flabjab.
The fight over lipodissolve raging in Missouri and Kansas represents one small skirmish in the battle among regulators, doctors and medical entrepreneurs to control the explosive growth of cosmetic medicine and to set standards for scientific proof of efficacy and safety. "Cosmetic medicine is an incredibly frightening and unregulated frontier right now," says Dr. Audrey G. Kunin, a dermatologist who has been discouraging fellow Kansans from getting lipodissolve treatments.
Lipodissolve practioners say the advantage of the procedure over liposuction is that it is much less invasive. Treatments typically cost $2,000 per body part and require a series of six injection sessions, spaced two weeks apart. Women most frequently request treatment on their abdomens and thighs while men choose love handles and jaw lines. A typical client signs up for two or three body parts.
Doctors and nurse practitioners that administer the treatments advise clients that the shots can cause stinging, swelling, redness and bumps and that the inflammation indicates the medication is working. According to one such practioner, Rob Semaan, the chief executive of a cosmetic clinic Fig., the lipodissolve is safe, and doctors have not reported any deaths or other serious consequences. Yet some, even doctors, who offered themselves as guinea pigs for the procedure have experienced problems.
Last year, when Dr. Young, the plastic surgeon, was considering offering the shots at his office, he asked an instructor at a lipodissolve course to inject his right flank. Thirty minutes later, he felt like he had been stung by 50 bees and his skin turned black, he recalls. A plastic surgeon in his office named Dr. C. B. Boswell, and their nurse, Holly Foelsch, also injected each other with PCDC. Dr. Boswell said that his stomach became so enlarged that he looked six months pregnant. Ms. Foelsch said that her thighs became so swollen with liquid that she wore panty hose to keep them from jiggling. All three reported that the side effects dissipated after two weeks but none of them experienced any cosmetic benefit."
Yet, counteracts Dr. Caplin, the medical adviser to Fig. that serious side effects have not occurred from treatments at its centers. "Certain techniques that use higher volumes than we do can get massive swelling," says Dr. Caplin, who added that the occasional patient at Fig. had experienced skin blistering.
Meanwhile, Dr. Young's practice has decided not to offer the shots to patients. But now he is about to start a pilot study of lipodissolve on 10 volunteers who will have PCDC shots on one side of their abdomens and a placebo on the other. Elsewhere, some doctors warn: "If they ban one drug, people will just start offering injections of a different drug cocktail. They ask for a total ban on any agent into the body that claims to reduce or eliminate body fat.