FDA warns medspas against advertising 'lipodissolve'

Key Points

His complication rate is low and his patients appear to be happy knowing that a board-certified dermatologist is treating them. He advertises his approach extensively, both in the local press and on his Web site. Patients seeking his treatments travel to his office from hundreds of miles away.

Dr. Cellulite uses a technique called "lipodissolve." He, like most healthcare practitioners doing this technique, uses a substance called deoxycholate. He advertises that his technique is both safer and more effective than liposuction.

Recently, a lawyer friend advised him to stop promoting this technique and perhaps even stop performing the procedure. Dr. Cellulite is resistant to such a notion, and notes that spas that offer the injections say they are safe and effective.

The attorney has informed him that public safety advocates have called for proof that mesotherapy works, have urged patients to think twice before paying thousands of dollars for an unproven procedure, and, most importantly, have become increasingly concerned about some of the complications reported at spas doing these procedures.

Dr. Cellulite refuses to change his ways. Is he making a mistake?

FDA warnings

In April, the Food and Drug Administration (FDA) issued a warning letter to six medical spas in the United States for making false or misleading statements on their Web sites about drugs they claim eliminate fat in the procedure called lipodissolve.

The FDA said the spas advertised that the drugs used in their lipodissolve procedures are safe and effective. However, the FDA noted that the drugs used by the spas had never been evaluated or approved by the agency. The most commonly used drugs are phosphatidylcholine and deoxycholate, usually in some sort of combination with other substances.

The spas notified were Monarch Medspa, King of Prussia, Pa.; Spa 35, Boise, Idaho; Medical Cosmetic Enhancements, Chevy Chase, Md.; Innovative Directions in Health, Edina, Minn.; PURE Med Spa, Boca Raton, Fla.; and All About You Med Spa, Madison, Ind.

A Brazilian company marketing its lipodissolve product on two Web sites ( http://www.zipmed.net/ and http://www.mesoone.com/) also received warning letters.

The FDA noted that not only have these substances not been approved, but also the involved companies have made claims that lipodissolve has an outstanding safety record and is superior to other fat-removal techniques, including liposuction. The letter to the Madison, Ind., spa stated that "the claims made for your lipodissolve products are false and misleading in that they are not supported by substantial evidence or substantial clinical experience."

Reports of adverse events

Moreover, some of the medical spa companies had advertised that the same products could be used to treat a variety of medical conditions such as gynecomastia, lipomas and some surgical deformities.

The FDA appeared to act, in part, because the regulatory agency had received reports of patient adverse events such as scarring, skin irregularities and painful subcutaneous nodules in the skin where the material had been injected.

FDA regulators called on the spas to stop making such claims and to notify the agency within 15 working days of steps they are taking to correct the violations.

Dr. Cellulite would be wise to heed his attorney friend's advice. Although he does not run a spa, his approach is the same as those spas that received the FDA warning letters.

David Goldberg, M.D., J.D., is director of Skin Laser & Surgery Specialists of New York and New Jersey, director of laser research, Mount Sinai School of Medicine, and adjunct professor of law, Fordham Law School.