FDA Issues More Warnings About LipoDissolve Injections
Posted by Cosmetic Surgery Review on April 16, 2010
LipoDissolve, also known as mesotherapy and LipoZap, has been available at hundreds of medical spas, cosmetic surgery centers and fitness centers around the United States for several years. The procedure works by injecting certain compounds directly into the fat cells, and encouraging fat cell breakdown within the body.
The types of compounds used in the treatment vary by practitioner, and are relatively unregulated, and now the U.S. Food and Drug Administration is cracking down on companies and surgeons that are offering the procedure.
The FDA recently sent out warning letters to six medical spas and a company in Brazil that have been making claims that LipoDissolve can eliminate fat. The compounds used in this procedure have not been approved, evaluated or deemed safe for eliminating fat in any capacity, and there is currently not enough scientific documentation to indicate that the treatment is effective or safe for eliminating fat permanently.
Most forms of the treatment contain varying concentrations of deoxycholate, phosphatidylcholine, vitamins, herbs and mineral extracts. These compounds are injected direclty into the fatty tissue, and work by breaking down the fat cells so that they can be eliminated naturally.
According to a story in American Health and Beauty, “The FDA is not aware of any credible scientific evidence that supports the effectiveness of these substances for fat elimination, and their safety when used alone or in combination is unknown.”
The spas that received the warning letter have just 15 days to provide a response to the FDA and indicate how they are correcting any claims that LipoDissolve can eliminate fat, and what they are doing to prevent future violations.
Some of the reported side effects of LipoDissolve and mesotherapy injections, include excessive and permanent swelling, skin discoloration, painful knots under the skin and excessive scarring.