April 7th, 2010
07:03 PM ET
By Val Willingham
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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