France bans mesotherapy

Here's an interesting development in the mesotherapy (melting fat by injection) story: as of early April 2011, the French Ministry of Health has outlawed all mesotherapy for the purpose of dissolving subcutaneous fat. Whether you call it "Lipodissolve", "mesotherapy", or "injection lipolysis"...it's no longer permitted there. The Ministry of Health views it to be a serious health risk. As you may recall, France was the birthplace of mesotherapy, about 50 years ago - so they probably know more than anyone about the technique.

It will be interesting to see what the reaction will be here. Lipodissolve methods have had a checkered past here in the USA, although there is starting to be some good science on compounds like ATX-101, which we've discussed in an earlier blog (link here).

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Could an asthma medication be the next fat-melter?

Answer: Maybe. Lithera, Inc. - a privately held pharmaceutical research group, recently presented some exciting results of a randomized, double-blinded study of their new injectable lipolysis drug, called "LIPO102" at the ASDS meeting.

In the study, volunteers were injected weekly in 22 locations in the abdomen and flanks with the drug, over 8 weeks. On average, the study group lost about 1/2" more of abdominal circumference than the control group did, without diet or exercise. Computerized 3-D imaging was used to take the measurements.

The fat reduction worked best in patients who were younger than 40 years and relatively thin.

Here's the interesting part: the ingredients in LIPO-102 are salmeterol xinafoate and fluticasone propionate. Asthma patients might recognize these medicines better as the very same ingredients that are used in Advair, the FDA-approved inhaler. The same beta receptors that are used to help relax the airways for asthma and COPD patients are also found on fat cells, where a beta agonist can trigger lipolysis. Dosing and administration, of course, are quite different between the two products.

Lithera isn't the only group with an injectable agent for melting fat, though. Kythera Biopharmaceuticals is also working on the same concept, with a totally different injectable formula called "ATX-101", which is also in the testing phase.

Impression: All very exciting, but very preliminary stuff. It may be the next generation of non-surgical body contouring, or it may turn out to be more trouble than it's worth. Much more research is needed.

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.

Recent bulletin on Carboxytherapy and Mesotherapy

Here is a recent press release from the Physicians Coalition for Injectable Safety - a group of 7 American, Canadian and International Surgery groups, including plastic surgeons, facial plastic surgeons and ophthalmic surgeons - who review & study the latest and best methods regarding injectable cosmetic products. For the record, I agree with this bulletin, and do not currently recommend mesotherapy and carboxytherapy, based on lack of proven efficacy.

PHYSICIAN GROUP URGES CONSUMERS TO BE AWARE OF NON-APPROVED COSMETIC INJECTIONS

July 29, 2009 - The Physicians Coalition for Injectable Safety today issued a consumer warning about carboxytherapy and mesotherapy injections. These products, touting everything from cellulite treatment to weight loss are not FDA approved, and do not have clinical data that demonstrates results or safety.

Carboxytherapy uses carbon dioxide gas injected under the skin to reduce the look of cellulite, treatment of dark under-eye circles, and stretch marks and is also touted for fat sculpting on the face and the body. “Although many websites or providers claim carboxytherapy is safe and FDA approved, it has not been clinically tested or FDA approved for these purposes,” says Coalition leader Robert Weiss, MD of Baltimore, MD. “Carboxytherapy for use around the eyes is especially dangerous. It could potentially release gas bubbles into blood vessels causing blindness. In addition, the risks of putting carbon dioxide in your body are currently unknown.”

Mesotherapy, also known as injection lipolysis, is a mixture of vitamins, drugs and enzymes that are compounded (mixed together) to make the injected substance. “There is no conclusive, authoritative information that exists, such as unbiased, peer-reviewed clinical studies that meets the standards of an accepted medical journal, measuring both the efficacy and safety of mesotherapy,” says Coalition leader Mark Jewell, MD, Eugene, Oregon. “We don’t know the safety or efficacy of these compounds and, until there exists credible evidence, consumers are advised not to have these injections.”

The Coalition urges consumers to be very selective about cosmetic treatments, and the individuals who provide them. “Only accept treatment prescribed by a qualified physician and administered under that physician’s supervision. Whether an injection or treatment is to treat aging conditions, to treat cellulite or a similar body contouring condition, whether it sounds reasonable or too good to be true, you should always be aware of false claims,” says Coalition leader Jeffrey Kenkel, MD of Dallas, TX. “Verifying that the drug or device that is recommended for your injection is FDA approved is an important first step. It should be approved specifically for cosmetic use as prescribed or similarly to what is prescribed for you.”