Can Shots Safely 'Melt Away Fat'?

By Sandra G. Boodman
Washington Post Staff Writer
Tuesday, June 26, 2007



Physicians Spar Over Injections Touted As an Easy Alternative to Liposuction



Beauty sometimes demands toughness, as many women discover, but Suzanne Thomas had never imagined she would agree to have 72 injections of a fat-burning chemical cocktail in her neck and chin.
Yet that is the treatment called lipo-dissolve that the 35-year-old Fairfax County preschool computer teacher underwent -- twice -- several months ago to eradicate the jowls and double chin she had long hated. Thomas said the discomfort was worth it because "I absolutely love my results."
"I just really didn't want to do anything invasive like liposuction," said Thomas, who, with three children younger than 6, would have little time to recuperate from cosmetic surgery. Her procedures, which cost a total of $1,000, were performed at MedSculpt, a six-month-old center in Rockville that specializes exclusively in the controversial fat-loss technique.
Marketed as a safer and less invasive alternative to liposuction, proponents say lipo-dissolve is useful for treating small "problem areas" such as love handles, bra fat and a softening jaw line. A growing number of doctors, nurses and even spa personnel are offering the procedure known in medical circles as injection lipolysis -- and more colloquially as the "flab jab."
But critics, among them officials of the American Society of Plastic Surgeons, the American Society of Dermatologic Surgery and the American Society for Aesthetic Plastic Surgery (ASAPS) say there is no convincing evidence that lipo-dissolve is effective -- or safe -- and they warn patients to stay away from fat-loss shots.
The procedure is similar to mesotherapy, an older treatment that involves injections of various drugs, vitamins or herbs to banish the dimpled flab known as cellulite. Lipo-dissolve injections typically contain two ingredients believed to work synergistically. As with mesotherapy, the formula, which is not approved by the Food and Drug Administration, is prepared by compounding pharmacies, which are subject to little regulation.
Lipo-dissolve "is catching on because it works," said Robert Adrian, one of the Washington area's best-known and busiest cosmetic dermatologists, who says he has treated 400 patients in the past three years. Adrian, whose Web site says the procedure "literally melts away fat in just a few short treatment sessions," maintains that most of his patients have achieved good long-term results.
Roger Friedman, a well-known Maryland plastic surgeon who is medical director of MedSculpt, which is set to open a second center in Tysons Corner on Thursday, says the procedure appeals to patients looking to lose inches without surgery.
"It's something plastic surgeons need in their armamentarium," said Friedman, who performs both lipo-dissolve and liposuction.
Officials of ASAPS, whose membership includes cosmetic dermatologists and plastic surgeons, vehemently disagree. Fat-loss injections, the group cautioned recently, are "scientifically unproven," lack approval from the FDA and use "poorly defined ingredients." The group cited "numerous reports of complications . . . including bacterial infection, granulomas [disfiguring masses of chronically inflamed tissue] and localized necrosis [tissue death]." To assess its safety and efficacy, the society is sponsoring a small placebo-controlled study of the procedure under the supervision of the FDA.
Medical experts aren't the only ones who have reservations. Kansas recently became the first state to regulate the treatment, sparked by concerns about the rapid proliferation of clinics and spas performing lipo-dissolve and the qualifications of practitioners.
Science or Snake Oil?

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"There is no real evidence that this is an advance over snake oil," said Alastair Carruthers, president of the dermatologic surgery society and a clinical professor at the University of British Columbia in Vancouver. What some proponents tout as impressive results, he said, appear to be temporary. And patients who shell out thousands of dollars of their own money for fat-loss injections, critics note, are more likely to watch what they eat and to exercise, which may explain why lipo-dissolve patients say they are satisfied with their results.
Safety remains a paramount concern, according to Carruthers. He said he recently treated a woman in her 40s who nearly lost both lower eyelids after she developed a potentially sight-threatening complication following lipo-dissolve injections administered by a physician. The shots killed tissue under her eyes.
Cosmetic dermatologist Elizabeth Tanzi of Washington said she has treated several patients with red lacy discolorations on their legs caused by lipo-dissolve. It is not clear whether the marks are permanent, she said.
Lipo-dissolve typically contains a mixture of phosphatidylcholine, which is derived from soybeans, and sodium deoxycholate, a bile salt that aids waste removal.
This cocktail, often dubbed "PCDC," is prepared in compounding pharmacies, which typically make small quantities of drugs for specialized treatments. Quality control and sterility can be spotty or nonexistent, experts say.
Using a fine needle, the PCDC solution is injected into fat deposits, typically in the abdomen, face, hips or back.
For large areas such as the stomach, as many as 120 injections may be required at one time. Sometimes the shots are administered using a rapid-fire instrument called a "mesogun" rather than a syringe. Numbing cream may be used first.
PCDC shots cause redness, temporary burning or pain and considerable swelling. The injections are believed to trigger an inflammatory response that results in the breakdown and excretion of fat; proponents say the mechanism by which this occurs is unknown. Two to six treatments are usually required, each of which costs $300 to $1,500.
When performed by experienced physicians, Adrian said, lipo-dissolve is safe and effective. Many doctors critical of the procedure, he contends, lack "basic scientific knowledge" and have ulterior economic motives.
"Lipolysis represents a significant threat to anyone who does liposuction," Adrian said. Typically plastic surgeons, not dermatologists, perform liposuction.
"This is not a procedure developed in some garage behind a house," he added, noting that it has been widely used in Europe.
To Friedman, the opposition to lipo-dissolve is reminiscent of the hostility that greeted liposuction when it was introduced in the United States in the 1980s. It has since become one of the most popular cosmetic procedures, and studies have demonstrated its safety and effectiveness, he said.
Safety Concerns

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The debate about lipo-dissolve mirrors the controversy surrounding mesotherapy, which was invented in France more than half a century ago. It is used to treat a host of problems including headaches, gout and cellulite.
Mesotherapy has been associated with serious complications. Brazil, known for its freewheeling attitude toward cosmetic medicine, banned injections of phosphatidylcholine, a common mesotherapy ingredient, in 2003 after the treatment had become so popular that shots were being given in gyms and beauty salons.
Two years ago the Centers for Disease Control and Prevention investigated the cases of 14 patients in the Washington area who developed prolonged swelling and skin ulceration from infections caused by mesotherapy injections administered by a man who claimed to be a physician from Colombia but did not have a valid medical license.
Although Friedman and others say that lipo-dissolve and mesotherapy are different, Carruthers said he fails to understand the distinction.
Michael Olding, chief of plastic surgery at George Washington University Medical Center and a spokesman for the American Society of Plastic Surgeons, said it is unclear what's in lipo-dissolve. "There is no accepted standard of what is included in these injections," he said.
In March, three people died after receiving injections of a drug made in a compounding pharmacy in Texas that was administered to patients at an alternative medicine clinic in Portland, Ore. Investigators found that the medicine, used to treat back pain, was 10 times more potent than the label indicated.
And two years ago, a contaminated solution used in open-heart surgery was linked to the death of four patients at Mary Washington Hospital in Fredericksburg. The solution was made by a large compounding pharmacy in Maryland; federal officials subsequently found significant contamination at the plant.
Lipo-dissolve proponents, including MedSculpt officials and Adrian, say that no deaths have been reported anywhere from the procedure and that their shots are carefully prepared in reputable pharmacies.
But in Tanzi's view, basic questions about the treatment remain unanswered.
"I had a baby two months ago," she said. "If I thought it worked and was safe, I'd have it." ·

Fonte: http://www.washingtonpost.com/wp-dyn/content/article/2007/06/22/AR2007062201870.html - 26/06/07