LIPODISSOLVE | It’s aimed at that fat that just won’t go away

‘Flab jab’ is all the fad, but regulation is thin

By PAUL WENSKE

The Kansas City Star, October 1, 2006

DAVID EULITT | THE KANSAS CITY STAR A patient received injections from advanced registered nurse practitioner Kimberly Evans at the Advanced Lipo Dissolve Center in Overland Park.

You exercise and eat right — still you can’t get rid of those stubborn pockets of fat hugging your hips or clinging to your thighs.

But are you ready for a flab jab?

Lipodissolve is the latest craze in body sculpting. It involves poking a needle under the skin and injecting a mixture of solutions intended to dissolve fat cells and flush them out of your body. It can take two to six sessions to get the desired result at a cost of about $400 per treatment.

Thousands of folks willing to spend thousands of dollars on treatments think it’s worthwhile. And Lipodissolve centers are opening across the country.

But not a lot is known about the treatment because it’s so new, and people are wondering whether it works.

Kimberly Hulse of Spring Hill, Kan., says yes. She is undergoing the needle at the Advanced Lipo Dissolve Center in Overland Park to trim pockets of fat on her hips left from a pregnancy about two years ago.

“I just want to be the way I was before I had my daughter,” said Hulse, who is otherwise healthy and exercises. “I’d been trying for two years to get rid of it (fat) and couldn’t get it off. And with these five treatments it’s gone. It’s awesome. It just feels so good.”

Until now, the only person she had told about the treatments was her husband.

“It’s just been my secret,” Hulse said.

Only one place offered Lipodissolve — a trademark name — in metropolitan Kansas City in April. Now at least 10 do.

Advanced Lipo Dissolve, which also offers dieting programs, had 400 clients its first month in May. The St. Louis-based business now plans more centers in Houston and Denver.

So what’s the attraction? More skin-baring fashions heighten desires for a shapely body. Many women want a tighter midriff. Men want to be rid of those love handles. But that doesn’t mean you can’t get fat again if you don’t maintain a good diet and exercise routine.

“What we’re dealing with is body shaping,” said John Hiebert, a board-certified plastic surgeon and the medical director of Advanced Lipo Dissolve in Overland Park.

Lipodissolve, however, is not a treatment for obesity. It is aimed at those resistant globs of fat that won’t go away no matter how much exercising or dieting you do. For that reason, Hiebert said, Lipodissolve offers a much less painful and less time-consuming alternative to liposuction, still the most popular body-contouring treatment.

It does not require invasive surgery like liposuction, which involves making a small incision and using a tool to literally suck out fat. And while there is some temporary swelling, bruising and soreness, there is no real downtime. You can do it over a lunch break.

Lipodissolve has not been approved for treating fat by the U.S. Food and Drug Administration — nor are there any peer-reviewed studies showing it even works.

But operators of Lipodissolve clinics and medical practitioners who promote the procedure say it is safe, and anecdotal evidence suggests it has worked for at least 50,000 patients across the country. In Europe, where many American practitioners have trained, it has been used for years.

“I’ve been around a long time and seen a lot of flash in the pans come and go,” said Hiebert who has long used liposuction to treat his patients. “The advantage of this product is that it works and is safe.”

Hiebert acknowledged being skeptical of Lipodissolve, until he went through training and even treated himself.

Study under way

Not all medical experts, however, are as confident as Hiebert. At its conference in April, The American Society for Aesthetic Plastic Surgery announced a major study of the treatment.

At the time, Mark Jewell, society president, said, “Our goal is to provide physicians and their patients with the information they need to make good decisions.”

He said the association could not currently endorse the treatments because “we don’t have enough clinical data or FDA approval to support their use.”

Alan Matarasso, a New York City plastic surgeon and spokesman for the American Society of Plastic Surgeons, said his group also was looking carefully at the process.

“Maybe it’s worth a shot,” Matarasso said. “But there are no standardized formulas and no standard techniques. That doesn’t mean it’s not good. We just don’t know a lot about it.”

An FDA spokesperson would not comment on the Lipodissolve craze. But she noted the agency in 2003 blocked a Web-based business from marketing an injectable product called Lipostabil that also promised to dissolve fat.

The FDA said the Web site operation was marketing Lipostabil in a manner that brought it under scrutiny as an untested “new drug.” The agency said the Web site’s fat-reduction claims — that included among other things that consumers could lose five to 10 pounds — were misleading “because there is no substantial evidence that the product is generally recognized as safe and effective for its intended use.”

Lipodissolve practitioners say their professional clinics, where licensed medical personnel supervise the process, are a far cry from fly-by-night Web marketers that might sell unsubstantiated solutions directly to the public. The clinics say they deal only with licensed pharmacists.

The FDA, however, does not regulate the clinics. The medical professionals that operate them fall mainly under the purview of state medical licensing boards. In order to be able to administer the injections, the clinics need to have a staff person, physician or medical practitioner who is licensed to obtain prescriptions. Basically, that is the only requirement to open one.

How it works

Lipodissolve refers to the micro-injection of a mixture of chemicals into target areas of fat under the skin. Some experts differentiate it from another similar treatment called mesotherapy, which has been used with mixed results to treat cellulite just below the skin.

Lipodissolve injections, however, go deeper into subcutaneous fatty areas and rely on a mixture of two natural-occurring solutions.

One is phosphatidylcholine, a natural component of cell membranes that is also sold as a food supplement called lecithin. The form used for Lipoissolve is extracted from soybeans. The other solution is deoxycholate, a solvent that is secreted by the liver to break up fat that enters the small intestine.

The solutions are prepared by compounding pharmacies. A doctor or technician injects a mixture of the solutions into the target area of the body. Proponents say two things happen: The fat cells swell and ultimately burst, after which the dissolved fat is flushed through the liver and excreted from the body. The process can take days to weeks.

Proponents say the process works the same as when doctors use lecithin to dissolve fat blockages in blood vessels. A patient may feel pain and see reddening of the skin in the first few days after a treatment. Tissue under the skin can also harden temporarily as the fat cells swell.

Only a small area of the body can be worked at a time, meaning that the process is not a good weight-reduction method, despite the claims made by some centers.

“You notice the difference in inches — not pounds,” said Matt Taranto, one of the owners of AesthetiCare Medi-Spa & Lipodissolve Center in Leawood. “This is not a magic wand,” he said.

Taranto said some ads may mislead consumers, using before and after photos that show fat-bloated bellies now handsomely sculpted, without explaining that those results also include a strict diet and exercise regimen.

Even so, Taranto contends at least 90 percent of consumers respond to treatment.

“We’re not dealing with a revolutionary new drug,” Taranto said. “You’re using medication that’s been around for 50 years. You’re just making new use of it,” he said.

Caution advised

So far, there have been few if any serious problems reported anywhere with Lipodissolve. An Internet search turned up only isolated consumer complaints of bruising, poor practices, or a lack of success against selected centers.

Still, the complaints underscore the need for consumers to question practitioners about their expertise and training, said Matarasso of the American Society of Plastic Surgeons. He said those questions should include how a technician obtains the compounds, how they are mixed, in what quantities, and how well they are injected under the skin.

In addition, Matarasso said, honest doctors offer consumers a range of options. Fly-by-night operators may recommend whatever they are hyping at the time, rather than what is most suitable.

“Don’t get me wrong, there may be something here,” he said. “But if you’re asking me what to tell a consumer, I would say, go in with your eyes wide open.

“We suspend reality when we deal with fat.”

Tips

•Try diet and exercise first to lose fat.

•Don’t choose a provider based only on price. Look for a well-qualified one with a medical background who offers a range of treatment options.

•Don’t be swayed by unrealistic promises. Clearly understand any guarantees and what they cover.

•Understand the risks and side effects and fully disclose any medical conditions and medications.

•Ask for names of other clients and get recommendations.

About Lipodissolve

•What body parts is it best for? Lower eyelid, double chin, jowls , hips, buttocks, abdomen, inner thighs, upper arms, under and upper bra areas, knees, saddle bags, love handles.

•How many treatments are needed? Two to six in intervals of six to eight weeks.

•How much does it cost? About $400 a treatment.

•Who are the best candidates for treatment? Healthy and fit people who want to reduce small, localized areas of resistant fat.

•Who are not good candidates for treatment? People who are obese or who have a high body mass index, have insulin-dependent diabetes, take blood thinners or anti-coagulants, or have active skin infections.

•Where can I find more information? From The American Society for Aesthetic Plastic Surgery: http://www.surgery.org/; the American Society of Plastic Surgeons: http://www.plasticsurgery.org/; and the American Society of Nonsurgical Aesthetics: http://www.asal-meso.com/.