The Fat-Melting Recipe: Under Fire continued...
"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.
Is It Really Lipodissolve?
As if the waters weren't murky enough, recently another iron was tossed into the fat-burning fire -- a controversy surrounding the term "lipodissolve" itself.
According to a group calling itself the American Society of Aesthetic Lipodissolve (ASAL), Lipodissolve (the treatment) is a trade name of a standardized protocol and products they claim have been tested for safety and efficacy.
The problem is that the term Lipodissolve has taken on a bit of generic meaning. In much the way the trade name Kleenex is often substituted for the word "tissue," ASAL claims "Lipodissolve" is being inappropriately used to describe garden-variety fat-busting injections.
To make their point, ASAL has launched several litigation suits attempting to stop the use of the trade name "Lipodissolve" by all unauthorized users.
Whether these lawsuits have merit remains to be seen. But Narins says the fact that they are being pursued should make you stop and think twice before submitting to treatment. "Even when you think you know what you are getting with this procedure, you don't really know what you are getting -- another reason to wait until we have legitimate medical research before participating in this treatment," she says.