FDA Information on Lipodissolve
On April 7, 2010, the U.S. Food and Drug Administration issued warning letters to six U.S. medical spas (cosmetic medical businesses that operate under the supervision of a licensed health care professional) that they are making false and misleading claims about their lipodissolve products. Lipodissolve, also known as lipozap, lipotherapy, mesotherapy, or injection lipolysis, is a cosmetic procedure that involves a series of injections over a period of months with the intention of dissolving pockets of fat in the body.
The false and misleading claims about these lipodissolve products include statements that they eliminate unwanted fat, have an outstanding safety record, and are superior to other fat loss procedures. Some medical spas also claim that lipodissolve products can treat medical conditions, such as male breast enlargement, benign fatty growths, and surgical deformities. FDA is not aware of any credible scientific evidence to support any of these medical uses.
In addition to the actions, the FDA also issued a letter to the Brazilian firm Zipmed Mesoone for selling unapproved lipodissolve products directly to consumers over the internet, and an import alert was also issued to prevent the distribution and importation of lipodissolve drug products into the United States.
Those companies that do not adequately address the violations stated in the warning letters risk further enforcement action, including injunctions that prevent additional violations and seizure of violative drugs.
Below is some additional information on lipodissolve and the actions FDA is taking.
Q: What drugs are used in lipodissolve procedures?
A: The main ingredients typically used in the lipodissolve cosmetic procedures are phosphatidylcholine (PC) and deoxycholate (DC). Neither PC nor DC are approved drugs in the United States to eliminate fat. Any claim that PC or DC is being used "off-label" for a lipodissolve procedure is false.
Lipodissolve products may also contain other substances, including pentoxifylline, lidocaine, aminophylline, calcitonin, isoproterenol, caffeine, vitamins, minerals, and herbal extracts. The safety and effectiveness of PC, DC, or the combination of these two substances when used alone or in combination with other ingredients for fat elimination is unknown.
Q: Are there any FDA-approved drugs for use in lipodissolve procedures?
A: There are currently no FDA-approved drugs for injection for fat elimination. FDA cannot assure the safety and efficacy of these types of drugs.
Q: What are the safety concerns associated with lipodissolve products?
A: The overall safety of lipodissolve products is not known. There are reports in the scientific literature of complications and adverse effects ranging from injection-site reactions (e.g., prolonged swelling, redness, pain), skin reactions (e.g., panniculitis, ulceration, abscess, necrosis, scarring) and skin infections. These adverse events may be attributed to the drugs injected, injection technique, or the formulation of the solution.
The FDA has also received several reports of adverse events through the MedWatch program in persons who have had the procedure using these drugs, including permanent scarring, skin deformation, and deep painful knots under the skin in areas where the lipodissolve treatments have been injected.
There is concern regarding unknown interactions between the various combinations of drugs used in lipodissolve procedures and maintenance of sterility of these injectable products.In addition, there is a lack of standardized formula and protocol for the injection of lipodissolve products in cosmetic procedures.
Medical professionals and organizations, including the American Society of Plastic Surgeons (ASPS) and the American Society of Aesthetic Plastic Surgery (ASAPS) have also issued position statements regarding lipodissolve that raise the following important concerns: (1) amount of fat that is dissolved; (2) problems that might evolve from injecting an uncontrolled amount of PC into subcutaneous tissue; and (3) short- and long-term adverse effects.
Q: How widespread is the marketing of lipodissolve products for cosmetic procedures?
A: Lipodissolve products are used in cosmetic procedures throughout the United States. Many medical spas have established internet websites to promote and offer lipodissolve products for cosmetic procedures. However, it is impossible to know the volume of drug products used in lipodissolve procedures. Pharmacies or medical spas are generally not required to register with FDA, or to report the products they produce or use.
Q: What should a patient do if they experience an adverse event associated with lipodissolve products?
A: Anyone who received or is currently receiving injectable lipodissolve products for cosmetic procedures should report any complaints or adverse events to MedWatch, the FDA's voluntary reporting program, by calling 800-FDA-1088 or electronically at http://www.fda.gov/medwatch/report.htm.
Q: Where can people find more information regarding lipodissolve products?
A: For more information, please see the following websites: