Treatment to melt fat has officials worried

The drug used in the injections is not approved by the FDA.
SCRIPPS HOWARD
LAS VEGAS -- The Advanced Lipo Dissolve Center in Summerlin, Nev., markets an alternative to liposuction with the slogan "it doesn't suck."
The Food and Drug Administration and the American Society of Plastic Surgeons, however, are not so sure.
The treatment, a type of mesotherapy, consists of a series of injections that the company claims permanently dissolve fat. As the slogan suggests, there is no surgery, and each treatment takes less than an hour.
If this sounds too good to be true, some think it may be.
Dr. Alan Matarasso, a spokesman for the American Society of Plastic Surgeons, said 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," Matarasso said. "Liposuction is the only recognized safe, proven procedure to remove fat cells."
Mesotherapy is a general term that describes injections beneath the surface of the skin in the mesoderm.
The FDA shares some of Matarasso's concerns. Spokeswoman Laura Alvey said that though 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.
Here are concerns
Alvey, in an e-mail to the Las Vegas Sun, explained some of the agency's concerns about the drug: "Phosphatidylcholine is sometimes used as a synonym for lecithin, but is, in reality, a natural component of commercial lecithin. Lecithin is found in all living organisms, but the commercial product is a crude mixture that can be extracted from various things."
The FDA has done a preliminary review of Advanced Lipo Dissolve's marketing information but could not determine if the company violates any regulations. However, the FDA has passed the material on to its compliance division.
Matarasso drew the comparison of a doctor recommending a pill that was not made or tested by a major drug company, not FDA-approved and about which the physician didn't know the long-term effects. Under such circumstances, he said, few would even consider the medication, but the rules change when people consider their self-image.
"When it comes to talking about fat, people suspend their beliefs, and it probably should be the opposite," he said. "You have something that's nonessential like fat removal or cellulite removal; it probably should bear higher scrutiny."
For healthy people only
Matarasso points out that the procedure is not performed on morbidly obese people whose weight causes a health risk but rather on generally healthy people.
Victor Ojeda, a spokesman for Advanced Lipo Dissolve, agreed the treatment is more for body sculpting than weight loss.
Dr. John Minoli, medical director for the Summerlin office, said patients with more serious weight problems are encouraged to lose that excess weight first.
Minoli said it usually takes four to six treatments for patients to see results. A treatment package, which costs about $2,000, includes up to nine treatments.
Biosalts contained in the injection infiltrate and kill the fat cells in the problem area, he said, and the body's shape changes over several weeks.
Ojeda said that although no results have been published, the American Society of Aesthetic Plastic Surgery is conducting clinical trials on the procedure.
Mike Odenthal of the organization confirmed that the trials had begun, but he could provide no details.