Saturday, August 30, 2008

Health

USN Current Issue

A Shot to Melt the Fat?

The treatment sounds great, but it's unproven

By Deborah Kotz
Posted 6/10/07

Corrected 6/20/07. A previous version of this story included an incorrect spelling of phosphatidylcholine.

Want to get rid of your stubborn fat bulges without endless spinning classes or going under the knife? A new fat-fighting procedure billed as liposuction without the risks is fast becoming popular at "rejuvenation clinics" and "medi-spas" throughout the country. Lipodissolve, as it is widely known, entails injecting small amounts of soy lecithin and bile salt directly into problem areas on the hips, waist, thighs, and buttocks, and voilà! the fat supposedly melts away. Sensing the next Botox, doctors from pediatricians to dermatologists have taken a weekend seminar and opened fat-dissolving clinics. "What once was a dream is now a reality," claims the website of LipoNOW clinic in Scottsdale, Ariz. "Expect to lose between 1 to 2 inches of fat with no invasive surgery," promises MedSculpt, a lipodissolve provider in Rockville, Md.

If it sounds too good to be true, that's what the competition thinks. The "body sculpting" procedure, virtually unheard of in the United States two years ago but practiced in Europe for decades, has raised the hackles of plastic surgeons, who argue that removing fat surgically is the proven option. Last month, the American Society for Aesthetic Plastic Surgery put out a statement saying that the scientific evidence doesn't exist to show that injection fat-loss treatments do any good or that they're safe. Unfortunately, "people often suspend reality when it comes to dealing with fat," says Alan Matarasso, a clinical professor of plastic surgery at Albert Einstein College of Medicine in New York who has researched the use of injections for dissolving fat.

No question, the injections are stealing business. "You have the perfect storm of desire for a nonsurgical procedure, easy availability, and ads promising painless fat removal," Matarasso says. Since 2005, when it first began offering its Advanced LipoDissolve treatment, the St. Louis-based company fig. (short for figure) has treated more than 11,000 patients at its nine clinics in six states; the company plans to have 20 clinics open by the end of this year, each overseen by a plastic surgeon. AestheticMD, a company that runs training sessions in the procedure, has taught some 2,000 doctors how to perform it since 2003.

Those who've tried the treatment give it mixed reviews. "My size 6 pants were so loose afterward that I had to get them altered. That's how I know it worked," says 32-year-old Noelle Stegmeyer of St. Louis, who spent about $3,500 two years ago to have Advanced LipoDissolve on her thighs and buttocks and was so grateful that she now does free testimonials for fig. By contrast, Angie Ross, 33, is hoping to take advantage of a money-back guarantee. Ross decided to have injections to her abdomen last November, thinking she could avoid the painful two-week recovery that her sister had endured after liposuction. After paying $4,000 and receiving several months of injections, the photographer from Overland Park, Kan., says she experienced abdominal swelling, weight gain, and an allergic reaction that sent her to the emergency room with hives all over her body.

Ross is seeking to get her money back. Jean Shepherd, fig.'s vice president of marketing, said in an E-mail that in such a situation, "the patient would be entitled to a refund and it would be processed in a timely manner." The company and the industry, she said, continue to study why some people don't respond to treatment.

One problem, says Bart Eastman, chief executive officer of AestheticMD, is that customers expect miracles when the technique produces subtle results. It can make a visible difference under the eyes and chin and in bra-line bulges, he says, but it won't remove as much fat as liposuction.

Pinpricks. The typical treatment consists of a series of injections that feel like pinpricks, given every two weeks in an average of six to eight visits. The substances supposedly destroy the fat cell wall, and the cell's contents are metabolized and excreted. Customers are told to expect mild bruising, soreness, and itching, which lasts a day or two, and some swelling, which can last up to three days. Any results can be expected to show up in several weeks, after the first two or three treatments. The fig. clinics charge $2,400 for one problem area, $4,000 for two areas, and $6,000 for three areas. LipoNOW charges $800 to $1,000 per area, and the MedSculpt patient typically pays $1,800 to $2,400.

Practitioners say that the fat-loss injections—which are sometimes referred to as mesotherapy—are less risky than liposuction because they're noninvasive and don't require anesthesia. With liposuction, "there's also the possibility that the cannula used to remove the fat will penetrate an organ," points out David Caplin, a plastic surgeon and the national medical director of fig. He says he's seen patients who have lost several inches around their hips, waist, and thighs after the injections and that recovery is quicker.

But the combined substance used in the injection isn't an approved drug. Although the individual ingredients are, like food, regulated for safety, they're not approved by the Food and Drug Administration to be injected for fat loss. But federal law allows pharmacists to compound chemicals into medications that are prescribed by doctors for individual patients. The most popular fatbusting mixture contains a combination of phosphatidylcholine (soy lecithin) and sodium deoxycholate (bile salt). Companies have their own proprietary formulas, so there can be variation in how the product is made.

"There's no uniform agreement among practitioners on what kinds of substances should be injected, in what concentrations, and in what combinations," says Alan Gold, president-elect of the ASAPS and a clinical associate professor of surgery at the Weill Medical College of Cornell University. What's more, he says, doctors who oversee the clinics may not administer the injections themselves but allow assistants, who may not be doctors, to do them. In May, Kansas began requiring physicians who administer lipodissolve to do an initial exam and write a prescription for the compound for each patient rather than ordering bulk quantities.

Even when clients can count on a good standard of practice, they have to go on faith that the injections actually work. Unlike liposuction, whose results can be stuck on a scale and weighed, lipodissolve's effectiveness is more subjectively measured as inches lost, weeks or months after treatment. Gold says that no one knows how much fat is shed or whether it winds up clogging other organs. A planned ASAPS-funded clinical trial comparing injections of phosphatidylcholine and sodium deoxycholate against placebo injections may yield some answers in the next year or two. The rate of side effects is unknown, too, but they include allergic reactions, skin ulcerations, scarring, and infections, according to Roxanne Guy, president of the American Society of Plastic Surgeons.

In most states, the fat-loss injections are considered a medical procedure that must be done under a licensed doctor's supervision. But that isn't always the case. An Ohio hair stylist, Richard Annabella, was arrested in April for practicing medicine without a license after he opened his own Liposolve spa and began treating patients. More than 60 customers, who suffered bleeding, infections, and ice burns from the numbing beforehand, have so far come forward to the police, according to Ray Arcuri, a lieutenant with the Westlake Police Department who is handling the case.

"I kept going thinking maybe it would work," says one former client, Cindy Strickland. "It was painful and left little cuts on my legs, but I wanted the end result." Annabella says that he administered phosphatidylcholine as a body wrap skin infusion, not as injections.

The bottom line, say plastic surgery experts, is that consumers should pass on the injections until they're proven safe and effective. "We really can't endorse the use of these injections at this time," says Guy. If liposuction seems too major and you can't make peace with the love handles, there's always the old standby: eating less and working out more.

This story appears in the June 18, 2007 print edition of U.S. News & World Report.

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