FDA to MedSpas: Your Lipodissolve claims are misleading…
FDA to medspas: your lipodissolve claims are misleading
Posted Friday, April 09, 2010 New Beauty Magazine
After countless medical professionals have expressed concern over lipodissolve and the people performing it, the FDA has decided to start cracking down on medspas that offer this unproven “fat-melting” treatment.
Lipodissolve involves injections of phosphatidylcholine and sodium dioxycholate, often with vitamins and often compounded right on the premises, that purportedly dissolve fat deposits. However, this procedure and its pharmaceutical composition has not been proven effective or safe. Regardless, it is offered by many facilities that advertise it as an alternative to liposuction, and it is often administered by staff with little to no medical training.
This week, a handful of medspas around the country offering lipodissolve received warning letters from the FDA stating, “The claims made for your lipodissolve products are false and misleading in that they are not supported by substantial evidence or substantial clinical experience.”
The FDA has yet to see credible scientific evidence of lipodissolve’s benefits, but they’ve seen plenty of complaints from consumers who were left with lumps, scars and deformities after undergoing the treatment.
In addition to citing the medspas, the FDA has also sent warnings to a Brazilian company that offers the mixtures. Almost immediately, the company put up a message on their websites stating, “Due to the current facts,” they “do not sell Lipodissolve vials anymore.”
The medspas have two weeks to stop what they’re doing and notify the FDA of their efforts to correct their violations.
What the Expert Says
Dr. Michael A. Epstein | Plastic Surgeon
Lipodissolve has been an effective treatment in our office medspa for the last 2 years. This treatment is performed by myself or one of my registered nurses and we have not only not had any significant long term problems with the treatments, but we have had many satisfied patients with their results. If expectations are set appropriately and the treatment is performed by a competent provider, this can still be a useful tool in our aesthetic procedure armament. Many treatments that physicians provide in medical practices are not FDA approved. Medspas outside of a trained physician’s office should only be performing very controlled and limited treatments.
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