FDA News

FDA Approves Investigational New Drug Application for 'Fat Melting' Injections

(Sept 04, 2007)-- The Aesthetic Surgery Education and Research Foundation (ASERF) announced that it has received approval from the U.S. Food and Drug Administration to initiate a clinical trial investigating the safety and efficacy of one type of injection lipolysis treatment.

Treatments most properly called injection lipolysis have been commonly associated with the terms mesotherapy or fat dissolving "Lipodissolve." These types of treatments claim to reduce or eliminate unwanted local accumulations of fat, but their ingredients and injection locations and techniques may vary slightly. There is also no standardized, consistent, and accepted injection protocol or chemical formulation, with many formulas being proprietary, and without scientifically valid studies documenting their safety or effectiveness or comparing one another.

Injection lipolysis involves the injection of various compounds into the subcutaneous fat, but is not currently approved by the FDA for subcutaneous injection for any purpose.

"We are pleased to finally have the approval to move forward on this important clinical trial," said V. Leroy Young, MD, chief investigator for the study. "This study is long overdue, and will go a long way toward
developing more standardized protocols and ultimately improving patient safety in this area."

The study, which was designed and funded by ASERF, will be conducted under FDA supervision and will follow patients for 46 weeks to evaluate the efficacy of one form of injection lipolysis and collect data on local and systemic reactions and any long-term complications. The study will include imaging, biochemical analysis and clinical measurements for objectiveevaluation of the efficacy and safety of the treatment.

"Although there are clinical reports of significant and positive results, they are all anecdotal, and unfortunately there is currently insufficient scientifically valid evidence to support the long term safety and efficacy of injection lipolysis. We hope that this study will provide the data needed to clarify some of the controversy and confusion
surrounding this potentially beneficial treatment. The more we know, thebetter we will be able to educate and inform our patients, and recommend to them, with confidence, the safest and most effective treatments to provide them with the best results," said Alan H. Gold, MD, president of ASERF.

According to the American Society for Aesthetic Plastic Surgery's 2006 Cosmetic Surgery Statistics, injection lipolysis procedures were performed last year on 28,901 Americans -- six times the number of procedures
performed the previous year.

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