FDA warns against selected mesotherapy to eliminate fat
The US Food and Drug Administration issued warning letters to 6 US-based medical spas and a company in Brazil for making false or misleading statements on their Web sites about drugs they claim “eliminate fat” in a procedure called “lipodissolve.”
Lipodissolve is also known as mesotherapy, lipozap, lipotherapy, and injection lipolysis.
First, the details.
- Lipodissolve is a procedure involving a series of drug injections intended to dissolve and permanently remove small pockets of fat from various parts of the body.
- The most commonly injected drugs are phosphatidylcholine (aka lecithin) and deoxycholate (a bile acid), usually in various combinations with one another.
- Sometimes, other drugs, vitamins, minerals, and herbal extracts are added to the mixture.
Here’s the problem.
- The FDA is not aware of credible scientific evidence supporting the effectiveness of any of these substances for fat elimination.
- Furthermore, their safety when used alone or in combination is unknown.
- The FDA has received reports of side effects in people who had the procedure using these drugs.
- Permanent scarring
- Skin deformation
- Deep painful knots under the skin where lipodissolve products were injected
The bottom line?
The warning letters were issued to the following companies.
- Monarch Medspa, King of Prussia, Pennsylvania
- Spa 35, Boise, Idaho
- Medical Cosmetic Enhancements, Chevy Chase, Maryland
- Innovative Directions in Health, Edina, Minnesota
- PURE Med Spa, Boca Raton, Florida
- All About You Med Spa, Madison, Indiana.
The Brazilian company markets lipodissolve products on 2 Web sites: zipmed.net and mesoone.com.
Healthcare professionals and consumers may report serious side effects or quality problems with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, mail, fax, or phone.
4/8/10 15:32 JR