Thank goodness! The U.S. Food and Drug Administration today issued warning letters to six U.S. based medical spas and a company in Brazil for making false or misleading statements on their Web sites about drugs they claim will eliminate fat in a procedure called “lipodissolve,” or for otherwise misbranding lipodissolve products. These companies involved have made claims that the drugs they use for their lipodissolve procedures are safe and effective; however, these products have not been evaluated or approved by the FDA for this use. Check out the Associated Press report that has my commentary on the topic featured on USA Today.
Lipodissolve is a procedure involving a series of drug injections intended to dissolve and permanently remove small pockets of fat from various parts of the body. It also is known as mesotherapy, lipozap, lipotherapy, or injection lipolysis. The most commonly injected drugs are phosphatidylcholine (a component of cell membranes in humans and other organisms) and sodium deoxycholate (actually bile salts), usually in various combinations with one another.
In some cases, other ingredients, including drugs or components of other products such as vitamins, minerals, enzymes, antibiotics, and herbal extracts are added to the mixture. Injectors usually get these cocktails formulated at compounding pharmacies, which adds to the lack of standardization in the mixtures from practitioner to practitioner. The FDA is not aware of any 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 press release states that it is requesting a written response from the U.S. companies within 15 business days of receipt of the warning letters stating how they will correct these violations and prevent similar violations in the future. Each U.S. company has been informed in its warning letter that failure to promptly correct the violations may result in legal action. Each of the companies involved has 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 more permanent fat loss procedures, including liposuction.
The FDA and other doctors have received reports of adverse effects in persons who have had the procedure using these drugs, including permanent scarring, skin deformity, and deep painful knots under the skin in areas where the lipodissolve products have been injected. I have seen contour abnormalities and firmness of the tissues in people who have undergone these procedures, or just no change at all in regard to their weight or contour. I do not perform these lipodissolve procedure, but see patients who may have tried it elsewhere after spending thousands of dollars with little to no result, and then seek the more clinically proven procedure of liposuction.
The warning letters were issued to the following U.S. companies: Monarch Medspa, 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, Fl.; and All About You Med Spa, Madison, Ind. The Brazilian company receiving a warning letter markets lipodissolve products on two Web sites: zipmed.net and mesoone.com. The procedures may also be offered by persons without sufficient medical training, thereby putting patients at risk of harm.
Patients seeking fat dissolving treatments should be educated about the lack of clinical data supporting these treatments and cautioned to wait until there is reliable information to guide their decision. I am glad to see the FDA cracking down on sham procedures and unqualified practitioners rendering aesthetic medical treatments. It's a step in the right direction if you ask me.
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