Lipodissolve involves a series of medicated injections that providers claim melt away unwanted small, localized areas of fat. Lipodissolve proponents say this technology can reduce fat pockets in the upper and lower abdomen, thighs and upper arms, as well as get rid of love handles, saddlebags, muffin tops, bra rolls, residual fat deposits from liposuction, fat pads under the eyes or chin, cellulite, stretch marks and scars. Some say this technology can improve skin tone and elasticity, as well as increase the production of collagen, a protein that keeps the skin firm.
While the ingredients used in lipodissolve may vary depending on the doctor and the area being treated, the chemical cocktail typically includes phosphatidylcholine/deoxycholate (PCDC), enzymes, plant extracts, multivitamins, and alpha lipid acid,. Phosphatidylcholine is a soybean extract, and deoxycholate is a bile derivative. While phosphatidylcholine is FDA-approved to break down blood fats that may increase risk for heart disease, the FDA has not approved phosphatidylcholine for injections for any purpose.
Some doctors may also add non-steroidal anti-inflammatory medications, antibiotics and hormones to the mix. These chemical cocktails typically are prepared in compounding pharmacies, which specialize in customizing formulations of drugs based on a doctor's orders.
During lipodissolve, your doctor injects the chemical cocktail into the fat layers and connective tissue. The injection is relatively painless, with no need for anesthesia. The medication produces a chemical reaction in conjunction with the body's physiology to dissolve localized areas of fat. Typically, benefits are seen within three weeks of the treatment. Several treatments, four to six weeks apart, are often required to produce the optimal result. There is no down-time after lipodissolve.
Between 50,000 and 100,000 lipodissolve treatments have been performed in the United States and Europe, according to statistics from the American Society of Nonsurgical Aesthetics, a trade group.
Lipodissolve: The Problems
Lipodissolve injections do liquefy fat, but where the fat goes is anyone's guess. Potentially it could be filtered through the liver, creating a fatty liver. Such excess fat in the liver can result in inflammation and possible scarring and liver failure.
The liquefied fat may also wind up in the blood vessels, where it could add to existing fatty plaque and increase the risk of heart attack or stroke.
Also, no studies have demonstrated where the medication travels or how it may affect organs. Nor does research exist on the optimal ingredients, proper dosages or short-term side effects. The American Society for Aesthetic Plastic Surgery (ASAPS) reports that infection, disfiguring masses of inflamed tissue and tissue death can occur after lipodissolve, especially when the procedure is performed by laypeople. Buyer beware: Some plastic surgeons are seeing indentations and divets (depressions) in the skin of people who have undergone lipodissolve. Such defects can be extremely difficult to correct.
Lipodissolve should not be used in pregnant women, nursing mothers or obese individuals; or in people with diabetes, autoimmune diseases, vascular (blood vessel) complications or infections of any kind. It is not an appropriate treatment for large areas of fat.
* Lipodissolve is billed as a non-surgical alternative to liposuction.
* It comprises a series of medicated injections that may dissolve small pockets of fat.
* Lipodissolve is not FDA-approved.
* The benefits and safety profile of lipodissolve are not firmly established.
* The American Society for Aesthetic Plastic Surgery (ASAPS) is studying the safety and effectiveness of this procedure.
Lipodissolve: Current Status
Lipodissolve is experimental. It is not approved by the FDA. Clinical studies in the United States that look at the safety and efficacy of lipodissolve are underway. Some medical practices that offer lipodissolve are also working toward establishing the right protocols for the procedure. Stay tuned.
At this time, neither ASAPS nor the American Society of Plastic Surgeons recommends the use of this technology. What's more, at least two states, Kansas and Nebraska, are in the process of enacting legislation to ban lipodissolve. Specifically, mesotherapy is temporarily banned in Kansas unless it is done as part of an FDA-approved clinical trial. Legislation in Nebraska is seeking to ban this procedure until it receives FDA approval. The state of Nevada is also considering such a ban.
And that is just in the United States. ANVISA, the Brazilian FDA, banned the use of phosphatidylcholine-based products for injectable fat removal because they have never been approved for cosmetic use. And Health Canada, the Canadian FDA, has ordered physicians to stop marketing and administering the products.
Lipodissolve: Study Update
ASAPS recently started a study of mesotherapy. The study protocol includes standardized ingredients and aims to look at safety and efficacy in a controlled and scientific fashion. In this study, 20 people will have half of their lower abdomen injected with phosphatidylcholine/deoxycholate (PCDC) up to four times, with a minimum of two times. The treatments will be spaced out eight weeks apart.
Study participants will have the option to get the other side of their abdomen treated if they are pleased with the results at the study's end. As of mid-June 2008, 10 people were enrolled.
Protect Yourself: What to Ask Your Surgeon Before You Choose Lipodissolve
Plastic surgeons and dermatologists may have experience with lipodissolve by participating in clinical trials. There may also be other types of doctors who are investigating the use of lipodissolve through study participation. Before you consider lipodissolve:
* Review the doctor's credentials, education, training, type of certification held and the number of times that he has performed the treatment.
* View before-and-after photos of patients with similar conditions who received lipodissolve and alternative treatments such as liposuction. As mentioned above, liposuction, a surgical procedure, is the only method that is scientifically proven to remove fat cells permanently.
* Ask about the ingredients in the medication and the amount of medication to be used in your procedure.
* Ask the doctor to estimate the number of treatments required to achieve and maintain the benefit.
* Ask about any possible interactions with your medical conditions or with medications you are already taking or plan to take.
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 eyes or chin will cost less than removal of saddlebags. The amount of medication required also depends on the area to be treated.
Sold on the Internet and used by some spas, lipstick is a procedure that its proponents claim will eliminate fat. U.S. companies claim that the drugs used in the procedure are safe and effective, but these products have never been approved by the FDA, the agency said."We are concerned that these companies are misleading consumers," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a prepared statement. "It is important for anyone who is considering this voluntary procedure to understand that the products used to perform lipstick procedures are not approved by the FDA for fat removal."Lipstick involves several injections that supposedly dissolve and remove small pockets of fat from areas of the body. Lipstick is also known as meshes, Lisa, lipstick, or injection lips. The drugs most often used are combinations of phosphate and deodorants. Sometimes other ingredients such as vitamins, minerals and herbal extracts are added into the mix, the agency sailboat, there is no "credible scientific evidence that supports the effectiveness of any of these substances for fat elimination, and their safety when used alone or in combination is unknown," the FDA said. The FDA has asked for a written response from the U.S. companies within 15 days outlining how they plan to correct the violations and prevent future violations. Failure to correct the violations could result in legal action, the agency said. Each company has been cited for a variety of violations, including making "unsupported claims that the products have an outstanding safety record and are superior to other fat loss procedures, including lipstick," the FDA said. Also, some of these companies have claimed that lipstick can treat certain medical conditions, such as male breast enlargement, benign fatty growths called lips, excess fat deposits and surgical deformities. "The FDA is not aware of clinical evidence to support any of these claims," the agency said. FDA officials have received reports of negative side effects from people who have tried the procedure, including permanent scarring, skin reformation, and deep painful knots under the skin in areas where lipstick drugs were injected. Warning letters were sent to: Monarch Med spa, King of Russia, Penn.; Spa 35, Noise, Idaho; Medical Cosmetic Enhancements, Chevy Chase, Md.; Innovative Directions in Health, Edna, Minn.; PURE Med Spa, Boa Eaton, Fla.; and All About You Med Spa, Madison, Ind. The Brazilian company receiving the warning letter sells lipstick products on two Web Sites: zipped and messing
the FDA said. The FDA also has issued an import alert against these Internet sites to prevent the drugs from being imported and distributed in the United States.