The FDA announced it had sent warning letters to six medical spas in the United States for making false or misleading statements on their Web sites about drugs used in the procedure. “We are concerned that these companies are misleading consumers,” says Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “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 FDA for fat removal.”

FDA is alerting consumers that:

• it has not evaluated or approved products for use in lipodissolve
• it is not aware of evidence supporting the effectiveness of the substances used in lipodissolve for fat elimination
• the safety of these substances, when used alone or in combination, is unknown
• it is not aware of clinical studies to support medical uses of lipodissolve

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

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

Consumers and health care professionals may report serious side effects with the use of lipodissolve products to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.

• online: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm4
• by regular mail: Use postage-paid, pre-addressed FDA form 35005
• by Fax: (800) FDA-0178
• by phone: (800) FDA-1088