“Lunch time Lipo”

When it comes to getting rid of body fat, sadly, people have become desperate to try anything. While they may live in fear of eating or drinking something containing a tiny fraction in parts per billion of some contaminant, they’ll let someone inject unknown chemical cocktails into their bodies with the promise to melt away fat.

Perhaps you’ve seen the television commercials, or the more than 147,000 websites, promising to sculpt your figure and give you a more youthful neck, trimmer underarms and more slender waist — all without surgery or dieting. These “fat-dissolving injections” claim to melt away fat and take years off your looks. They go by brand names such as Lipodissolve and Lipostabil and may be called lipolysis, thin injections, Lipo-zap, Flab-Jab, lipotherapy or mesotherapy.

But, it turns out, Lipodissolve and the rest are not approved for use as fat treatments by the U.S. Food and Drug Administration.

In fact, the FDA has even issued warning letters against those marketing and distributing these injectable “fat-dissolving” products. In a July 22, 2003 warning letter, for instance, the FDA specifically said that claims that these products are legal to sell and inject because they are “nutritional supplements and hence don’t fall under FDA’s jurisdiction” were false. As John M. Taylor, Associate Commissioner for Regulatory Affairs at the FDA, explained: “Congress defined the term dietary supplement as a product that... is ingested, is intended to supplement the diet, [and] is labeled as a dietary supplement.” Since Lipodissolve is injected, it is a drug... and an unapproved one, at that.

Yet, Lipodissolve is growing in popularity. It’s proven irresistibly lucrative for the estimated 10,000 anti-aging spas and cosmetic plastic surgeon offices around the country now offering them.

Doctors can make $375 to $1,500 per treatment, with up to six treatments required, according to Dr. Alan Matarasso, M.D., FACS, a New York City board-certified plastic surgeon.

As Lisa Nicita reported in the Arizona Republic, since it’s unregulated, doctors don’t have to report adverse outcomes to anyone and also don’t have to be registered with a board:

[P]hysicians can be trained on the procedure at seminars, such as those held at the Academy of Aesthetic Medicine in Tempe, Ariz. For about $2,500, physicians receive eight hours of hands-on training, a certificate of training and a starter kit of supplies. Anyone can purchase a kit online for less than $400.

This week, a medical board in Kansas became the first in the nation to take responsibility to address this increasingly popular practice in order to protect patients. Under new regulations issued by the Kansas State Board of Healing Arts, Lipodissolve may not be administered to any patient unless it is part of an investigational clinical drug trial. In the new regulations, Article 22-Dishonorable Conduct, now says licensed medical professionals “shall not administer or authorize the administration of phosphatidylcholine or sodium deoxycholate, or any combination of these substances, by subcutaneous injection for the purpose of eliminating or reducing localized fat accumulation.”

Mark Stafford, the Board’s general counsel, told the Kansas City Star that the regulations were in response to complaints involving unscrupulous business practices and patients suffering side effects. “We have to protect the public from the potentially disastrous effects of unproven drugs,” he said.

Lipodissolve contains phosphatidylcholine (PPC) sodium deoxycholate (DC) along with any number of other ingredients, depending on the doctor or clinic, said Dr. Matarasso. Each doctor creates his/her own cocktail.

The New Technologies Subcommittee on Fat Transfer and Liposuction for the American Society for Dermatologic Surgery examined the research on these injectables and issued a Technology Report last year. They found that there was no standardization in formulas being used and they contain things like “prescription medications — vasodilators, antibiotics, the caffeine, aminophylline, hormones like calcitonin and thyroxin and the beta agonist, isoproterenol, enzymes (collagenase and hyaluronidase), herbal extracts, vitamins and minerals.” Most all, though, contain a soy lecithin extract, phosphatidylcholine, (Sanofi-Aventis):

Initially it was thought that this was the responsible agent for the nonspecific lysis of cell membranes — emulsification of fat cells (lipolysis) — and the cause for fat reduction. However, recent data suggests that the cell lysis may in fact be due to the action of deoxycholate, a natural detergent used in these formulations.

These solutions are injected into the subcutaneous fat using needles or mesoguns (which have also not been approved by the FDA for safe use in the U.S. But they don’t actually “melt” or “dissolve” fat as is claimed in advertising, according to the American Society for Aesthetic Plastic Surgery:

Instead, PPC and/or DC appear to kill (lyse) adipocytes. It has been hypothesized that treatment with phosphatidylcholine and deoxycholate reduces subcutaneous fat either by adipocyte necrosis due to direct toxic or surfactant effects, or by mobilization of triglycerides secondary to activation of hormone sensitive lipase. Studies have found that subcutaneous adipose tissue following PPC/DC treatments shows evidence of nodules of fat necrosis, threadlike strands of scar tissue, cell-wall disruption, focal inflammation, and collagen deposition.

To date, however, there is no objective data on precisely how these injections work, but there are numerous reports of complications documented in the medical literature, including bacterial infection, granulomas (disfiguring masses of chronically inflamed tissue) and localized necrosis (tissue death), said the ASAPS.

“[P]resently, there are no randomized, double-blinded controlled studies in the literature that unequivocally establish the safety and efficacy of this procedure for medical or aesthetic conditions,” concluded the ASDS Technology Report. Lipodissolve is currently being investigated in a randomized, double-blind, placebo-controlled clinical trial under FDA supervision.

"[T]he long-term effects of Lipodissolve have not been established,” said Dr. Matarasso. “Because different doctors use different ingredients, it is difficult to give a meaningful prediction of results from past procedures. There are no significant studies demonstrating where the medication travels or how it may affect organs, what the proper dosage or ingredient requirement is, the short term side effects, or long-term complications.” Until adequate safety and efficacy information is available, the FDA won’t approved it for cosmetic use. “The FDA requires much more supporting data than is required in Europe,” he explained. He especially cautioned that Lipodissolve “should not be used for pregnant women, nursing mothers, obese patients; or people with diabetes, autoimmune diseases, vascular complications, or infections of any kind.”

“Safety needs to come first. We do not have definitive information on injection fat loss treatments. All we have is a few small studies and anecdotal evidence. Until we know more, we cannot recommend these procedures to patients,” Foad Nahai, M.D., president of the ASAPS told Medical News Today. “The bottom line for patients is this: Don’t allow yourself to be injected with an unknown and untested substance.”

© 2007 Sandy Szwarc