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 fu
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