Fat-Busting Injections Under Scrutiny

Controversy surrounds a treatment that promises to dissolve fat with a series of injections.

From the WebMD Archives

What if you could banish forever those jiggly thighs, bumpy upper arms, double chin -- even your muffin top -- with just a few simple injections?

That's the promise of a type of mesotherapy treatment known as lipolysis, also known under the trademarked name of Lipodissolve.

Utilizing a chemical cocktail and a series of between four and 10 injections, experts say it can literally melt a certain degree of fat from anywhere on the body it accumulates -- at a cost of between $150 and $800 per body part. And at least some medi-spas and salons offering the promise appear to be thriving.

"The truth is these injections can work -- but at the moment, not without significant concerns," says David Goldberg, MD, director of Skin Laser and Surgery Specialists of New York and New Jersey, and one of the few doctors to have been involved in small clinical trial of the procedure.

Reports of complications with fat-busting injections have included infection, disfigurement, inflammation, and tissue death. Additionally, a lack of credible research on the effects of fat-busting injections and associated side effects has already led to the treatment being banned in Brazil. For the same reason, both England and Germany have severely curtailed the promotion of these treatments.

In the U.S., the American Society for Aesthetic Plastic Surgery (ASAPS) warned consumers against their use, citing unknown safety data and a potentially high rate of complications. Also, the Kansas State Board of Healing Arts issued temporary restrictions on the use of the fat-melting Lipodissolve injections in December 2007.

Many doctors agree with the precautions.

"These are uncharted waters with an untested, unproven treatment. And while it may one day prove safe and effective, right now we don't know that, and until we do, having this treatment means you are taking a very big chance that you could regret," says Rhoda Narins, MD, professor of dermatology at NYU Medical Center in New York City.

At the same time, treatments in the U.S. and abroad are flourishing, not only in medi-spas and salons, but in doctors' offices as well. A safety data survey of some 75 doctors from 17 countries published in the Aesthetic Surgery Journal in 2006 reports the vast majority of treatments performed are safe and effective.

So who's right? Before you can make that decision, it's important to understand a little more about what mesotherapy is, how fat-dissolving injections work, and what exactly we do and don't know about this treatment.

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Mesotherapy and Fat-Dissolving Injections: What You Should Know

In general, all fat-busting injections fall under the general heading of a medical procedure known as "mesotherapy," first developed in France as early as 1952.

"By definition, mesotherapy is the injection of something into the skin, and there is nothing inherently wrong with that practice," says Goldberg.

He also cautions that the "consumer definition" of mesotherapy narrows down the term to mean an injection that melts fat -- now loosely referred to in the media and advertising by the trademarked name Lipodissolve.

The differences, however, are important. While mesotherapy studies abound, there have been no double-blind, published, peer-reviewed medical studies conducted specifically on fat-melting injections -- something doctors say leaves us with little or no information on how they really work.

"We know, for example, that these injections do liquefy fat, but what we don't know is where it goes or how the body deals with it, and if there are any long- or short-term dangers associated with treatment," says Ellen Marmur, MD, chief of dermatologic and cosmetic surgery at the Mt. Sinai School of Medicine in New York City.

Among the possibilities, she says, is that the liquefied fat is filtered through the liver -- which, she says, might contribute to a fatty liver. Another possibility is that it ends up in the kidneys, or more likely, says Marmur, in the blood vessels, where it could create or add to existing fatty plaque, thus increasing the risk of heart attack or stroke.

"At this point, we really don't know for certain where the fat goes because there have been no direct studies of liquefying fat and its potential for long-term harm," says Marmur.

And while proponents of the procedure report that patient follow-ups have not yielded any significant changes in lipid profiles, Marmur points out that most, if not all, of this information is anecdotal. "Until it's proven in a clinical trial, we can't bank on it as fact," she says.

Where the fat goes may only be the tip of the hypodermic when it comes to potential problems with this treatment. Another issue of concern: the risk of infection and some serious consequences.

"The threat of infection is very real. Whenever you are dealing with an injectable substance, sterility is a major issue, and if this treatment is not being done in a doctor's office, which many of them are not, then I would worry," says Goldberg.

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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.

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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.

Considering Fat-Busting Injections?

The good news is that several clinical trials on fat-busting injections are under way. Beginning this month, Goldberg reports that his office, along with several other centers nationwide, are beginning a major study for a company that has the intention of submitting data to the FDA for a new drug approval. The ultimate goal: to provide the data necessary for the manufacture of a regulated fat-busting injection.

Unfortunately, however, reports are it will be at least two years or more before the studies are completed and drugs approved.

In the meantime, if you do try this treatment, the experts we interviewed offered these suggestions.

  1. Have your treatment performed by a doctor or by a trained physician's assistant or nurse with a doctor on the premises.
  2. Have your treatment done in a medical environment to ensure sterility and infection control.
  3. Be realistic about your expectations. At best this procedure is meant to "sculpt" areas of the body, not drop you down two jean sizes.
  4. Inform the doctor doing your treatment of any drug allergies or other medical conditions.
  5. Avoid fat-busting injections if you suffer from HIV, hepatitis C, active cancer, liver disease, kidney disease, bleeding disorders, diabetes, thyroid disorders, or if you are pregnant or nursing. You should also use caution if you suffer from heart disease, a cardiac rhythm abnormality, or if you have a history of blood clots or strokes.
  6. Report any signs of infection following treatment to your doctor. These include pain, swelling, or redness at the site of injection, fever, aches and pains, or headaches.
WebMD Feature Reviewed by Louise Chang, MD on January 17, 2008

Sources

SOURCES:

David Goldberg, MD, director, Skin Laser and Surgery Specialists of New York and New Jersey.

Rhoda Narins, MD, professor of dermatology, NYU Medical Center, New York City; former president, American Society of Dermatologic Surgeons.

Ellen Marmur, MD, chief of dermatologic and cosmetic Surgery, Mt. Sinai School of Medicine, New York City.

Steve Silverman, assistant director, Office of Compliance, Center for Drug Evaluation and Research, FDA.

Duncan and Chubaty, Aesthetic Surgery Journal, 2006; vol 26: pp 575-585.

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