|Avoid mesotherapy/injection lipolysis treatments until further research on safety, efficacy |
New York, NY (May 14, 2007) - The American Society for Aesthetic Plastic Surgery (ASAPS) released today a warning against the use of injection fat loss treatments. Patients are advised to avoid these procedures, which are commonly known as lipolysis, mesotherapy, or the brand names Lipodissolve and Lipostabil. Although marketed as fat loss treatments, these procedures are scientifically unproven, lacking any objective data on safety and efficacy. In addition, none of these procedures has received FDA approval, with the ingredients poorly defined. The procedures may also be offered by persons without sufficient medical training, thereby putting patients at risk of harm.
“Safety needs to come first. We do not have definitive information on injection fat loss treatments. All we have is a few small studies and anecdotal evidence. Until we know more, we cannot recommend these procedures to patients,” said Foad Nahai, MD, president of the Society. “The bottom line for patients is this: Don't allow yourself to be injected with an unknown and untested substance.”
Despite media and advertising claims that mesotherapy or injection lipolysis treatments can safely and effectively eliminate unwanted fat, published peer-reviewed scientific reports of properly performed controlled prospective trials to confirm either safety or efficacy do not exist. Furthermore, there is no objective data on how these treatments produce ‘fat dissolving' effects and there are numerous reports of complications documented in the medical literature, including bacterial infection, granulomas (disfiguring masses of chronically inflamed tissue) and localized necrosis (tissue death), particularly when injections were done by lay people.
“ Mesotherapy treatment centers are opening all over the country and these consumer outlets may not be staffed by trained medical professionals. Patients seeking fat dissolving treatments should be educated about the lack of clinical data supporting these treatments and cautioned to wait until there is reliable information to guide their decision,” said Alan H. Gold, MD, president of the Aesthetic Surgery Education and Research Foundation (ASERF). “For now, the only proven method for eliminating unwanted fat cells is suction assisted lipoplasty, a procedure that has a long and successful track record for both safety and effectiveness."
A placebo-controlled study is being sponsored by ASERF to demonstrate safety and efficacy—or lack thereof—of one type of injection lipolysis treatment. The formula that will be used for injection in this 20-patient study —phosphatidylcholine (PPC)/sodium deoxycholate (DC)— is one that has shown the most promise in small, published trials. The study, which will be conducted under FDA supervision, will follow patients for 46 weeks to evaluate the efficacy of PPC/DC for injection lipolysis and collect data on local and systemic reactions and any long-term complications. At present, n either drug being studied in this trial is FDA approved for subcutaneous injection for any purpose. Once completed, the results will be published in the Aesthetic Surgery Journal and presented at an annual ASAPS meeting.