There's no proof the procedures work and serious side effects can occur, agency says,,
WEDNESDAY, April 7 (HealthDay News) -- 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.
For more on lipodissolve, visit the American Society of Plastic Surgeons.
SOURCES: April 7, 2010, news release, U.S. Food and Drug Administration
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