FDA Cracks Down on Lipodissolve Procedures

Posted: April 8, 2010

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In addition, the FDA has reports of unexpected side effects in people who’ve undergone the lipodissolve procedure. These side effects include:

• permanent scarring;
• skin deformation; and  
• deep, painful knots under the skin in areas where the lipodissolve treatments were injected.

Actions taken by the FDA

On April 7, 2010, the 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. (Cyber letters are letters sent to companies whose U.S. online sales of products may be illegal.)

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; and 
• are superior to other fat-loss procedures, including liposuction.

Additionally some of the letters indicate that the companies have made claims that lipodissolve 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 U.S. companies receiving warning letters in regard to lipodissolve products are:

• Monarch Med Spa, King of Prussia, PA
• Spa 35, Boise, ID
• Medical Cosmetic Enhancements, Chevy Chase, MD
• Innovative Directions in Health, Edina, MN
• Pure Med Spa, Boca Raton, FL
• All About You Med Spa, Madison, IN