April 7th, 2010
07:03 PM ET

FDA warns about 'lipodissolve' fat-busting claims

By Val Willingham
CNN Medical News Producer

The Food and Drug Administration on Wednesday  issued warning letters to six U.S. medical spas and a company in Brazil, accusing them of making false or misleading statements on their Web sites about a procedure called "lipodissolve."

The companies allegedly made claims that the drugs they use for their lipodissolve procedures are safe and effective. Yet the FDA says these products have not been evaluated or approved by the FDA for use in the procedure.

Lipodissolve is a becoming a popular form of cosmetic treatment that claims to eliminate fat. But it remains controversial. The "fat melting" process is made up of a series of injections intended to dissolve away small pockets of fat from the body, permanently. The procedure is also known in the industry as mesotherapy, lipozap, lipotherapy, or injection lipolysis. The most commonly injected drugs used in lipodissolve are phosphatidylcholine and deoxycholate, usually in various combinations with one another. But they are experimental because neither of these drugs has been approved by the FDA for dissolving fat, either alone or together.

The warned companies claim other ingredients, including drugs or components of other products such as vitamins, minerals, and herbal extracts, are added to the mixture. And they advertise that their products as safe and they bust fat. The FDA warns it is not aware of any scientific evidence that finds these concoctions are effective or safe. "They make the procedures sound so good, so safe and that they work so well," says Kathleen Anderson, deputy director of the Division of New Drugs and Labeling Compliance, Office of Compliance, CDER. "And they just haven't been proven, there is no evidence they work," she continued. "People need to know that, "

The FDA has received five reports from people reporting serious side effects they've had from having liposdissolve, including scarring, painful knots under the skin and skin deformations.

The federal agency is requesting a written response from the U.S. companies within 15 business days of their intent to correct the violations, or they'll face legal action or fines.

The companies have been cited for a variety of regulatory violations, including making unsupported claims that the products have an outstanding safety record and are superior to other fat loss procedures, including liposuction. Additionally some of the letters indicate that the companies have made claims that lipodissolve products can be used to treat certain medical conditions, such as male breast enlargement, benign fatty growths known as lipomas, excess fat deposits and surgical deformities. The FDA says it has no scientific proof these products do what the companies claim.

"We are concerned that these companies are misleading consumers," said Janet Woodcock, M.D., director of the 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 the FDA for fat removal."

The warning letters were issued to the following U.S. companies: Monarch Medspa, King of Prussia, Pennsylvania; Spa 35, Boise, Idaho; Medical Cosmetic Enhancements, Chevy Chase, Maryland.; Innovative Directions in Health, Edina, Minnesota; PURE Med Spa, Boca Raton, Florida; and All About You Med Spa, Madison, Indiana. The Brazilian company receiving a warning letter markets lipodissolve products on two Web sites: zipmed.net and mesoone.com.

It is important to note these are not the only companies or clinics using lipodissolve. Many dermatologists and physicians across the country tout lipodissolve as a great way to get rid of fat and treat their patients with these injections right in their offices. As for now, the FDA is going after companies that make false claims about lipodissolve on their Web sites, but the agency did say lipodissolve is still available in other places and anyone getting the treatment is taking a chance.

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soundoff (14 Responses)

    I, personally had many of these procedures done over several months. As of this day, which has been several years ago since I had it done, I still have knots and sore spots where the injections took place. Several months after I stopped taking them the facility closed down and I'm still trying to get my money back. They assured that the procedure was "painless" , safe & guaranteed to "melt" the fat. First of all, the injections were excruciating let alone they injected me up to about 25 times per visit with the same needle. I guess they didn't realize I worked in the medical field for 30 years, (at that time). They also told me that they were safe, another lie and if I didn't lose the fat that I could get my money back. Well, I GAINED weight & am still trying to get my money back. The name of the facility was FIG. DON'T DO IT LADIES!!!

    April 8, 2010 at 01:21 | Report abuse | Reply
  2. Devilnuts

    When are people going to learn that there is no "miracle cure" for being healthy?

    You cannot buy a healthy lifestyle, you have to live it. And the celebrities who think they can throw a million dollars at some hack surgeon and become younger - you're only fooling yourselves.

    April 8, 2010 at 01:22 | Report abuse | Reply
  3. Medical Spa MD

    I just read about this on MedicalSpaMD.com


    It's been in the making for a while now since the FDA really does not like the fact that the components are unknown and it's being mixed and sold by individual physicians (or others) with no oversight, testing, or quality control. The FDA looks like they're serious.

    April 8, 2010 at 21:06 | Report abuse | Reply

    I received several of these treatments & did not see any results except for dark areas still on my thighs after 2 years. The treatments were very painful. I was told that I would see results immediately, but guess what, there were no positive results. I suffered & spent my family's hard earned money for nothing. I'm still paying on it!! I even drank the expensive FIJI water that they said would help the results. This was the biggest rippoff!!!

    April 14, 2010 at 15:07 | Report abuse | Reply
  5. Bill

    Try doing some PT everyday. Lipo, pills, gastric bypass....all panaceas for low self estemm, low motivation, lack of discipline, and poor eating habits. Start running. Start lifting. Stop stuffing your face. Up the workout, lower stuffing the piehole and alter your diet towards something healthy. It ain't rocket science.

    April 14, 2010 at 22:42 | Report abuse | Reply
  6. Eileen

    I had a series of mesotherapy treatments done a few years ago, and it was absolutely painful for several days afterward. I was told I had to do a treatment a week for 10 weeks. In the end, I did not see any results and thus wasted money and had to tolerate the pain. Don't do it!

    April 14, 2010 at 22:42 | Report abuse | Reply
  7. Jerrod

    Am I the only one who has had positive results?? I was so angry when the Fig office where I was getting my injections closed down. I literally went one day and boom, no office. Needless to say I was angered, but mostly because my results were 100% fantastic. Yes, they were painful (inner thighs and love handles), but with some pain meds and 48 hours of relaxation after the injections, I was good as new. I'm a triathlete who was always 10-12 lbs above where I needed to be and after just 4 months of treatments, I had my abs back, a smooth lateral ab area and reduction of fat on my quads. Fantastic treatment, worth the pain....

    June 10, 2010 at 21:47 | Report abuse | Reply
  8. Gregoria Pedaci

    The Spa exudes a surreal kind of zen-like feel. The facials are all so relaxing. I love the Himalayan Salt therapy room. I can't wait to come back with a group of girls for a ladies weekend retreat. http://www.facialmaniaspa.com. Hands down best spa in South Florida


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