8/30/06
The Advanced Lipo Dissolve Center, Las Vegas, is marketing an alternative to liposuction. However, the US Food and Drug Administration (FDA) and the American Society of Plastic Surgeons (ASPS) are not too fond of the procedure.
The treatment is a type of mesotherapy that consists of a series of injections that contain a combination of biosalts that the company claims permanently dissolve fat cells in the problem area. The injections are intended to change the body’s shape over a course of several weeks. There is no surgery and each treatment takes less than 1 hour.
Alan Matarasso, MD, spokesman for the ASPS, says the procedure has some potential, but there is no science to support it yet.
“While mesotherapy is very intriguing, it is an unknown, unproven commodity,” says Matarasso. “Liposuction is the only recognized safe, proven procedure to remove fat cells.”
The FDA shares Matarasso’s concerns. Spokeswoman Laura Alvey says that although the agency does not regulate medical procedures or methods, it does control the drugs and devices that are used in the procedures.
Phosphatidylcholine, a drug used in the injections, is not FDA-approved, and the agency issued a cease-and-desist letter to a New York company that marketed the drug for similar use in 2003.
The FDA has done a preliminary review of Advanced Lipo Dissolve’s marketing information, but could not determine whether the company violates any regulations. The material has been passed on to FDA’s compliance division.
The treatment takes four to six treatments before patients see results. A treatment package, which costs about $2,000, includes up to nine treatments.
The American Society of Aesthetic Plastic Surgery is currently conducting clinical trials on the procedure.
[www.lasvegassun.com, August 29, 2006]
