ASAPS 2010: some science on Mesotherapy

One of the most interesting presentations at the recent ASAPS meeting was the long-awaited results of the lipodissolve / mesotherapy study. Dr. V. Leroy Young, who is an extremely careful and thoughtful researcher, presented the findings.

The study used volunteers with a BMI < 30 and without significant skin laxity, who had a series of injections into their abdomen in an attempt to reduce their subcutaneous fat deposits. There was no dieting, no other drugs, lasers or surgery used. The typical grid pattern of injections was used to one-half of the abdomen, with a pre-mixed combination of mesotherapy agents (PPC/DC). The patient had a series of up to four treatments into the same area, at intervals of 8 weeks. This method was chosen to mimic what is done at many mesotherapy clinics. Careful monitoring was done with a multitude of measurements, photos, lab tests, and CT scans - before, during and after the series of injections. By only treating one-half of the abdomen, each patient served as their own control.

There were no significant changes in BMI or skin-fold thickness, and no blood test changes as a result of the treatments.

In reviewing the photos, the before and after "result" photos looked very similar to me. Not much of a change. If there were changes in body shape, I thought that they looked pretty subtle. If I were the patient, I would be pretty disappointed in these results!

There were a couple of CT scans where I could really see a difference in thickness of the fat layer - so something was happening, at least in some patients, some of the time. According to Dr. Young's numbers, there was an average reduction of 7% in the subcutaneous fat thickness.

There were no major adverse effects reported in the mesotherapy study group, but patients' post-op complaints included pain, swelling and nodule formation. Despite that, most of the patients wanted to go ahead and treat the opposite side!

Bottom line: It's good to finally see this kind of non-biased, carefully controlled research being done. Personally, I was not impressed with the changes, but it might have some application for small areas where a little further refinement of a result might be desired following real liposuction. Too early to tell on that idea, though.

When the final report is issued in the Aesthetic Surgery Journal, I will be able to comment on it in more detail.

FDA issues warnings about Lipodissolve

From the FDA website...

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It's a tempting premise: Get a series of drug injections and see pockets of fat on your body go away for good. But the Food and Drug Administration (FDA) is alerting consumers about false and misleading claims being made about products used in lipodissolve, and about other misbranding of these products.

Recipients of lipodissolve get a series of drug injections intended to dissolve and permanently remove small pockets of fat from various parts of the body. The process is also known as injection lipolysis, lipozap, lipotherapy, and mesotherapy.

“We are concerned that these companies are misleading consumers,” says Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “It is important for anyone who is considering this voluntary procedure to understand that the products used to perform lipodissolve procedures are not approved by FDA for fat removal.”

The drugs most regularly used in the lipodissolve injection regimen are phosphatidylcholine and deoxycholate (commonly called PC and DC, respectively). Other ingredients may also be used, including drugs or components of other products such as vitamins, minerals, and herbal extracts.

What Consumers Should Know:
- FDA is alerting consumers that it has not approved products for use in lipodissolve.
- It is not aware of evidence supporting the effectiveness of the substances used in lipodissolve for fat elimination.
- The safety of these substances, when used alone or in combination, is unknown.
- It is not aware of clinical studies to support medical uses of lipodissolve.

In addition, FDA has reports of unexpected side effects in people who’ve undergone the lipodissolve procedure. These side effects include: permanent scarring, skin deformation, and deep, painful knots under the skin in areas where the lipodissolve treatments were injected.

FDA Actions:
On April 7, 2010, FDA announced it had sent warning letters to six medical spas in the United States—and a cyber letter to a company in Brazil—for making false or misleading statements on their Web sites about drugs used in the procedure, or for otherwise misbranding lipodissolve products.

The U.S. medical spas receiving warning letters make various unsupported claims about lipodissolve, such as assertions that the products used in lipodissolve:
"are safe and effective"
"have an outstanding safety record"
"are superior to other fat-loss procedures, including liposuction".

The U.S. companies receiving warning letters in regard to lipodissolve products are
Monarch Med Spa, King of Prussia, Pa.
Spa 35, Boise, Idaho
Medical Cosmetic Enhancements, Chevy Chase, Md.
Innovative Directions in Health, Edina, Minn.
PURE Med Spa, Boca Raton, Fla.
All About You Med Spa, Madison, Ind.

Lipodissolve & Mesotherapy: the low-down

Here's a hot topic: can you melt fat by injecting certain active substances into it, and is this safe to do? Those are the key questions to be determined when in comes to injection lipolysis, also known as Lipodissolve, Flab-jab, and a number of other proprietary names.

Currently, the two most commonly used drugs, the soybean-derived phosphatidylcholine (PC) and a bile-salt derivative called deoxycholate (DC), are not FDA-approved for this purpose. These are injected, sometimes with a cocktail of other ingredients, into the fat, using a grid-like pattern. This is typically repeated at intervals, until the desired results are seen, or the patient gives up, or runs out of money!

While this procedure is poorly-understood and needs a whole lot more research to determine the best way to do it, here's what we do know from the scientific studies:

1) The injections don't "melt" fat - they cause the fat cells to rupture, killing the fat, which is then replaced by scar tissue;
2) The DC seems to be more effective in causing the effect, compared to the PC;
3) Some studies have found no benefit whatsoever; others have seen a measurable effect, with a reduction in fat;
4) We don't really know the optimal dosage and mix of ingredients;
5) We don't know where the "melted" fat goes, and whether this process has side effects;
5) Some people have reactions to the injections, with pain, swelling and lumpiness. Fortunately, most of these reactions are usually transient;
6) Some people have no response to the treatment, other than the inevitable thinning of their wallet. These people usually come to me later, for actual liposuction.

So far, I feel that injection lipolysis should be classified as an experimental procedure. Although I'm very interested in it, I don't offer it to my patients. I feel that the details really need to be worked out first. Liposuction is still the undisputed standard for fat removal.

Regulatory approval would also help me feel better about this technique. When the FDA, Health Canada, the UK's Medicines and Healthcare Products Regulatory Agency (MHRA), and the Brazilian version of the FDA all speak out against this procedure, that should tell you something. It's probably not "ready for prime time" yet.

The research wing of ASAPS (American Society for Aesthetic Plastic Surgery) has a study going on this right now. I'll post the results as soon as they are available. Personally, I'd like for this technique to work - it would add another useful method to those we use currently, and would be minimally-invasive, as well. We'll have to wait and see...