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Thursday
Apr082010

FDA Warns 6 Medical Spas About Lipodissolve Marketing

Lipodissolve (or liposolve or mesotherapy) is a staple in any number of medical spas, but the FDA has just issued a warning letter to 6 clinics that they've crossed the line in marketing lipodisolve to patients.

My own experience with lipodissolve mesotherapy is something of a mixed bag. Clinics that I've been associated with have offered liposolve in the past and I'm aware of one really scary incident where a woman had been treated in Park City over a large area (thights and stomach as I remember) and then went golfing. She colapsed at the golf course and was rushed to the ER at the University of Utah.

She recovered but the administering physician faced some pointed questions from the ER docs about what he'd injected and why.

(The lipodissolve treatment causes fluid accumulation and swelling temporarly. That fluid comes from the blood stream and when there's a large treatment area, that can be a lot of fluid. This can affect the patient's blood pressure and volume, in some cases dramatically. This patient's recent treatment combined with golfing in the sun, walking, and dehydration was enough that she tipped over and (I think) lost conciousness for a few moments.)

If you're offering lipodissolve, leave a comment below and detail your experiences, results and thoughts... especially if you're from one of the 6 medial spas named below.

Anyway, here's the FDA story via USNews.com

FDA Issues Warning on 'Fat-Melting' Spa Injections

There's no proof the procedures work and serious side effects can occur, agency says

Claims by spas that "lipodissolve" injections can melt away fat are unsubstantiated and the procedures' safety also remains in question, according to warning letters issued Wednesday by the U.S. Food and Drug Administration.

The FDA warned six U.S. based medical spas and a Brazilian company to stop making false claims about the drugs used in these procedures.

Sold on the Internet and used by some spas, lipodissolve is a procedure that its proponents claim will eliminate fat. U.S. companies claim that the drugs used in the procedure are safe and effective, but these products have never been approved by the FDA, the agency said.

"We are concerned that these companies are misleading consumers," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a prepared statement. "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 the FDA for fat removal."

Lipodissolve involves several injections that supposedly dissolve and remove small pockets of fat from areas of the body.

Lipodissolve is also known as mesotherapy, lipozap, lipotherapy, or injection lipolysis. The drugs most often used are combinations of phosphatidylcholine and deoxycholate.

Sometimes other ingredients such as vitamins, minerals and herbal extracts are added into the mix, the agency said.

However, there is no "credible scientific evidence that supports the effectiveness of any of these substances for fat elimination, and their safety when used alone or in combination is unknown," the FDA said.

The FDA has asked for a written response from the U.S. companies within 15 days outlining how they plan to correct the violations and prevent future violations. Failure to correct the violations could result in legal action, the agency said.

Each company has been cited for a variety of violations, including making "unsupported claims that the products have an outstanding safety record and are superior to other fat loss procedures, including liposuction," the FDA said.

Also, some of these companies have claimed that lipodissolve can treat certain medical conditions, such as male breast enlargement, benign fatty growths called lipomas, excess fat deposits and surgical deformities.

"The FDA is not aware of clinical evidence to support any of these claims," the agency said.

FDA officials have received reports of negative side effects from people who have tried the procedure, including permanent scarring, skin deformation, and deep painful knots under the skin in areas where lipodissolve drugs were injected.

Warning letters were sent to: Monarch Medspa, King of Prussia, Penn.; Spa 35, Boise, Idaho; Medical Cosmetic Enhancements, Chevy Chase, Md.; Innovative Directions in Health, Edina, Minn.; PURE Med Spa, Boca Raton, Fla.; and All About You Med Spa, Madison, Ind.

The Brazilian company receiving the warning letter sells lipodissolve products on two Web Sites: zipmed.net and mesoone.com, the FDA said.

The FDA also has issued an import alert against these Internet sites to prevent the drugs from being imported and distributed in the United States.

Well, the zipmed and mesoone sites are both down and have this simple statement.

Due to the current facts, Mesoone.com and Zipmed.net do not sell Lipodissolve vials anymore. Thank you. For more information access www.fda.gov

Leave a comment below.

Reader Comments (9)

I'm so happy the FDA is finally stepping in do something about Mesotherapy! Personally, when I had one session of Meso in 2003, I developed a severe infection and the pain was considerable. Besides feeling like and idiot afterwards and being scolded for doing something so silly by my M.D. husband, I fell pray to some fancy marketing and just had to try out a session. I was one of the unlucky ones who developed a severe infection with considerable pain, and looked as if I had been in a major car accident. One long and miserable month later, when the bruising and swelling finally went down, I was left with some the same amount of fat I had around my abdomen to start with, except it was now clumpy and hardened. When I had liposuction in 2007, the fat was so hardened around my belly button from the Meso, I had to wait another 6 months then have the lipo again because they couldn't even out the hardened meso knots the first time around. I am suprised the FDA has not acted sooner because I know I am not alone in experiencing these extreme side effects.

Here's what Mayo Clinic has to say about Mesotherapy: (www.mayoclinic.com/health/cellulite/DS00891) "This procedure involves injecting a solution — which may contain a combination of aminophylline, hormones, enzymes, herbal extracts, vitamins and minerals — under the skin. This treatment can cause several unwanted effects, including infection, rashes, and bumpy or uneven skin contours." To treat Cellulite, Mayo Clinic recommends Diode laser energy or Radio Frequency.

04.13 | Unregistered Commenterwendyh

Don't "mix" Mesotherapy and Lipodissolve together.

Mesotherapy is a injection technique from France which is used with many different drugs for many different conditions, like cellulite, hair loss, but also headache and low back pain.

Lipodissolve is injection lipolysis which is using PPC/ DOC with some additions. There are a number of reliable studies already done. An experienced and trained physician is having good results with the right patient selection. Like everything in medicine, it did not work well on "every body". But incidents like described above you can prevent by drinking two extra liters of water the same day and cease exercises for 3 days.

I have good results with Mesotherapy and Lipodissolve, and there are tested drugs on the way. I just got a feasibility request for a phase III clinical study these days.

04.17 | Unregistered CommenterCutanis

Mesotherapy is indeed used in France and even more it is paid back by the French National Health security insurance to citizens who have mesotherapy act by their doctors.
Of course it is for medical reasons like explained above.
Doctors in Europe received proper diploma and education in mesotherapy at the University, since it is proven to be efficient

No matter how hard I try, I personally cannot find any conclusive, unbiased peer-reviewed clinical studies that meet the standards of an accepted medical journal that measures both the efficacy and safety of mesotherapy, liopdissolve, lipo shots, lipozap, ect… And hey, it looks like the FDA may agree with me on this one. If you can point me to the direction of any such clinical studies I can try to form a more objective opinion. In the meantime, all I have to go by is the month-long severe pain I suffered after having one session of mesotherapy performed on me. This pain was so horrible I can’t seem to block it out of my mind when anyone dares mention the word mesotherapy. Sorry guys, but these days I feel it is my life mission to warn others not to do this treatment.

04.21 | Unregistered Commenterwendyh

WendyH, I'm not sure if these studies meet the standard you requested, but there are more out there:

Salti G, Ghersetich I, Tantussi F, Bovani B, Lotti T. Phosphatidylcholine
and sodium deoxycholate in the treatment
of localized fat: A double-blind, randomized study. Dermatol
Surg. 2008;34:60–66.

Myers P. The cosmetic use of Phosphatidylcholin in the treatment of
localized fat deposits. Cosmet Dermatol. 2008;19:416-420

I feel sorry something went wrong with your treatment, but don't blame Mesotherapy,
since it may have not been Mesotherapy (like e.g. I do it).

04.23 | Unregistered CommenterCutanis

Researched extensively by scientists, Phosphatidylcholine has been shown to play a vital role in many important areas including maintaining cell structure, fat metabolism, memory, nerve signalling, as a precursor to important neurotransmitters, and liver health.

08.12 | Unregistered CommenterJared

Hi WendyH,
I had several sessions of meso in 2009 and also looked like I had been in a major car accident. Meso left me with 30 plus puss filled nodules all over my body which had to be surgically removed. I still have lumps under my skin that are very painful. Not sure where to go or who to talk to about the side effects and other symptoms I am experiencing. Please Help!

12.23 | Unregistered CommenterCarla

It is still amazing to me to see how easy it is to get $$CUSTOMERS$$$$ for procedures that the customer knows nothing about and can not find reliable information about. Perhaps they want the "promises" of the procedure so badly that they overlook the concept of "checking it out". NOBODY TOUCHES THIS TEMPLE I LIVE IN unless I am positive of the success rate and have a list of the side effects possible with it. Just because the "OPERATOR" wears a WHITE COAT does not make it true. They are lierally "fighting" to give their money away and there are plenty to take it.

SURGERY is ANY PROCEDURE THAT ALTERS THE STRUCTURE and/or FUNCTION OF THE AREA BEING TREATED.
Many of the customers do not realize they are undergoing SURGERY by unlicensed operators. I can understand why people do it but I can't comprehend why these people do not investigate the process more thoroughly. They are putting their life into someone elses hands.

12.24 | Unregistered Commenterlefty2g

Does anyone have experience using mesotherapy to diminish lipomas? I have a patient with multiple benign lipomas (over 100) confirmed benign by biopsy.

10.24 | Unregistered CommenterMcMillin

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