Lipodissolve called unsafe by FDA
"We are concerned that these companies are misleading consumers," said Janet Woodcock, M.D., director of the 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 the FDA for fat removal."
On April 7, the agency sent letters to six medical spas accusing them of making false and misleading claims about lipodissolve, including that it's better than other fat-loss procedures like liposuction. The letter also warns the businesses that they have 15 days to tell the agency how they will correct the violations and prevent similar violations. The spas are: Monarch Med Spa in King of Prussia, Pennsylvania, Spa 35 in Boise, Idaho, Medical Cosmetic Enhancements in Chevy Chase, Maryland, Innovative Directions in Health in Edina, Minnesota, All About You Med Spa in Madison, Indiana, and PURE Med Spa in Boca Raton, Florida.
A warning was also issued to a Brazilian company that sold the treatments directly to consumers through Web sites zipmed.net and mesoone.com.
The crackdown "is a great day for patient safety," says Dr. Renato Saltz, president of the American Society for Aesthetic Plastic Surgery (ASAPS). "I grew up in Brazil and am very familiar with the mess lipodissolve made there." ASAPS does not approve of lipodissolve, because "right now, there is no science and no data" to prove that it works. It issued its own warning to consumers back in 2007.
Lipodissolve -- also called lipozap, lipotherapy, mesotherapy or injection lipolysis -- claims to permanently melt fat by injecting a drug cocktail directly into the fatty area. The cocktails are a varying mix of vitamins, herbal extracts, minerals with chemicals like phosphatidylcholine (commonly called PC) and deoxycholate (DC).
The problem is that there is no standardization or oversight, says Dr. Anthony Youn, a board certified plastic surgeon based in Michigan. "Essentially a physician injects whatever concoction he or she believes works. These medications, although legal to use, have not been FDA approved as safe and effective for what these doctors are using them for."
As a result, the agency has received complaints about permanent scarring, lumpiness and skin deformation.
ASAPS has been working since 2007 on finding consumers the answer. It's conducting a FDA-approved clinical study on the safety and efficacy of one type of lipodissolve. Results of the study will be presented at the annual ASAPS meeting in two weeks, followed by a report to be presented to the FDA.
Dr. John Perrotti, a board certified Manhattan plastic surgeon and assistant clinical professor of surgery at New York Medical College, believes that a FDA-approved injectible solution is in the industry's future. Meanwhile, think twice, he says. "The medical industry has stayed away, especially plastic surgeons and dermatologists. You run the risk of running into some problems."