She loved it despite her ordeals
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 teacher underwent — twice — several months ago to eradicate jowls and a double chin. Thomas said the discomfort was worth it because “I absolutely love my results.” The procedures, which cost a total of $1,000, were performed at MedSculpt, a six-month-old center in Rockville, Md., that specializes in the controversial fat-loss technique.
If you don’t know about lipo-dissolve
Basically, Lipo-dissolve typically contains a mixture of phosphatidylcholine, which is derived from soybeans, and sodium deoxycholate, a bile salt that aids waste removal.
Just like Kybella, it is 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 colloquially as the “flab jab.”
How it is Administered
Using a fine needle, the PCDC solution is injected into fat deposits, typically in the abdomen, face, hips or back.
For large areas, 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.
Side effects should be expected
PCDC shots cause temporary burning and swelling. (See user comments at www.realself.com) The injections are believed to trigger an inflammatory response that results in the breakdown and excretion of fat.
Proponents agree this is a common effect but say exactly how this occurs is unknown. One study reported a more serious side effect “multisystem Organ Failure” following LipoDissolve Injections.
Procedure continues despite warnings
On April 7, 2010, the FDA scolded six U.S. spas and one Brazilian company for making false and misleading claims about fat-melting injections which included lipodissolve.
“They make it sound so good and so safe,” said Kathleen Anderson, the deputy director of the FDA’s Division of New Drugs and Labeling Compliance, during a news conference. “[They claim] it dissolves fat — melts it away with no side effects — and they have done thousands of procedures, and it really sells well,” she says. “We are really concerned because we have had reports of complications, and we have no good data that say this is safe and this is effective.”
“Side effects reported to the FDA include permanent scarring and deep, painful knots under the skin in areas where the lipodissolve cocktail has been injected”, she says.
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.
Lipo-dissolve “is catching on because it works,” said Robert Adrian, a dermatologist, 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 results.
Officials of ASAPS, whose membership includes cosmetic dermatologists and plastic surgeons, 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).”
Medical experts aren’t the only ones who have reservations. Kansas 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.
“There is no real evidence that this is an advance over snake oil,” said Alastair Carruthers, a clinical professor at the University of British Columbia in Vancouver. What some proponents tout as impressive results, he said, appear to be temporary.
Safety remains a big concern, according to Carruthers. He treated a woman 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.
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.
Michael Olding, chief of plastic surgery at George Washington University Medical Center, said it is still unclear what’s in lipo-dissolve. “There is no accepted standard of what is included in these injections,” he said.
“Right now, a lot of companies are pushing treatments with no data and no proof of safety, and devices approved by FDA are being used for other things. It’s a Wild West out there,” ….“Don’t be lured by fancy marketing, have a big dose of skepticism when you see ads, and ask someone qualified what the real scoop is.” says Felmont F. Eaves III, MD, the ASAPS president-elect and a plastic surgeon in Charlotte, N.C.
What is the current status of Lipodissolve?
Lipodissolve is still currently considered an experimental treatment. It is not approved by the FDA. Clinical studies in the United States that look at the safety and efficacy of lipodissolve are under way. Some medical practices that offer lipodissolve are also working toward establishing the right protocols for the procedure.
Costs for lipodissolve may range from $375 to $1,500 per treatment. Up to six treatments may be needed.
The extent of treatment also makes a cost difference. For example, fat removal under the chin will cost less than removal of “saddlebags.” The amount of medication required also depends on the area to be treated.
You personally know someone who has undergone successful Lipodissolve treatment and you also want to try it?
We advice you be careful. Here are some reminders and questions to ask your surgeon about Lipodissolve
Some plastic surgeons and dermatologists have experience with lipodissolve through clinical trial participation. Before you consider lipodissolve:
- Review the doctor’s credentials, education, training, type of certification held and the number of times that he or she has performed the treatment.
- Ask about the exact ingredients in the medication and the amount to be used in your lipodissolve procedure.
- Ask the doctor to estimate the number of treatments required to achieve and maintain the benefit.
If you have seriously made up your mind, we advise you to be a bit more open minded.While your next step might be consultation with a board-certified plastic surgeon or dermatologist who is familiar with Lipodissolve.
Discuss your concerns and goals with the doctor so he or she can better determine which treatment or treatments are right for you. If your surgeon suggests an alternative treatment such as liposuction, be sure to ask about all aspects of the procedure too.