FDA Warns Medical Spas to Stop Making False Claims About Lipodissolve

Perhaps you’ve seen online advertisements for a supposed “miracle cure” that will literally melt away unsightly fat from your body. Those advertisements undoubtedly featured Lipodissolve, a procedure typically performed at “medical spas” where a concoction of drugs are injected into the body. Typically, the drugs most commonly used in the procedure include phosphatidylcholine and deoxycholate, but other ingredients are not uncommon, either. For example, vitamins, minerals, and herbal extracts may also be incorporated. Overall, adverse events associated with these varying ingredients include injection-site reactions, prolonged swelling, redness, pain, itching, and mild to serious skin reactions (ulceration, abscess, scarring, and infections).

If, after reading the extensive list of side effects, you still think this sounds like a convenient and quick way to rid yourself of bulge, think again. The Food and Drug Administration recently issued warning letters to six United States-based medical spas as well as the company in Brazil who manufacturers the Lipodissolve products. Specifically, the FDA’s letters warned the medical spas and the manufacturer to stop posting false or misleading information about the procedure.

Yesterday, Dr. Kathleen R. Anderson, the deputy director of the FDA’s Division of New Drugs and Labeling Compliance, described the claims made about the effectiveness of Lipodissolve. For example, claims have been made that Lipodissolve can eliminate unwanted fat, has an outstanding safety record, and can also treat other medical problems including male breast enlargement, benign fatty tumors, and surgical deformities. She warned that the "FDA is not aware of any credible scientific evidence to support any of these medical uses”. Other medical associations, including the American Society of Plastic Surgeons and the American Society of Aesthetic Plastic Surgery have also issued statements regarding their concern about the short- and long-term effects of Lipodissolve.