On April 7, 2010, FDA announced it had sent warning letters to six medical spas in the United States—and a cyber letter to a company in Brazil—for making false or misleading statements on their Web sites about drugs used in the procedure, or for otherwise misbranding lipodissolve products.The U.S. medical spas receiving warning letters make various unsupported claims about lipodissolve, such as assertions that the products used in lipodissolve
- are safe and effective
- have an outstanding safety record
- are superior to other fat-loss procedures, including liposuction
- None of the drugs/products used in the procedure have been evaluated or approved by the FDA.
- The FDA is not aware of evidence supporting the effectiveness of the substances used in lipodissolve for fat elimination.
- The safety of the substances used in lipodissolve, when used alone or in combination, is unknown.
- The FDA is not aware of clinical studies to support medical uses of lipodissolve.
- permanent scarring
- skin deformation