Fat-Busting Injections Under Scrutiny
The Fat-Melting Recipe: Under Fire
But it's not just the procedure that has some doctors worried. For some, a lack of control over the substances used to melt the fat is of equal or greater concern.
Currently, the most common fat-melting cocktail is PCDC, a mixture of a soybean derivative known as phosphatidylcholine, and a bile salt known as deoxycholate.
PCDC itself has not been approved as a fat-busting injection -- or anything else. Instead, those performing the treatment are forced to have it manufactured at a compounding pharmacy, a type of drugstore that makes medicines from scratch via a doctor's prescription. Some see this as the weakest link in the treatment chain.
"The problem with this treatment is not really the substances, it's that there is no regulation of production. Every compounding pharmacy is making it differently -- the concentrations are different, there is zero regulation or control. So in essence, no one is ever really certain what their 'fat injection' is going to contain, or more importantly, how it's going to react in their body," says Goldberg.
"A certain amount of fat is necessary under the skin to protect the structures underneath. In the neck you have your external carotid artery, you have muscles and other important structures, and without some fat you're prone to injury. Removing too much fat could be a real problem," says Marmur.
Moreover, while the injections themselves reportedly cause only mild discomfort, and most patients have virtually no downtime after the treatment, there are also significant reports of short-term problems for some. These include everything from swelling, redness, and full-body hives to dizziness, sweating, fainting, fever, diarrhea, unexpected menstrual bleeding, and even one report of a woman who lost all her hair following treatment.
Narins says lumps and bruising are also common, as well as the possibility of "granulomas" -- lumps under the skin that can require surgery to remove.
While the ingredients used in the injections have not yet been approved by the FDA, compounding pharmacies are subject to certain compliance principles and can be held responsible for the drugs they produce, according to Steve Silverman, assistant director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research.
Silverman says fat-busting injections are on the FDA's radar screen and that the agency is "looking at it closely." But Silverman said that as a matter of policy, he could not talk about when or if they will take any enforcement action.