BackgroundMesotherapy is the practice of injecting chemical preparations such as enzymes, hormones, plant extracts, vitamins, and/or other substances into the dermal layer of the skin (intradermal) or the deeper, subcutaneous tissue layer beneath the skin for cosmetic purposes.
Injection lipolysis is a type of mesotherapy using a nonsurgical procedure that involves administering a series of injections under the skin into the subcutaneous layer to break down fat cells in the areas around the injection sites. Preparations utilizing deoxycholic acid (DCA) and/or phosphatidylcholine (PPC) are known to be used for injection lipolysis. DCA and PPC are both emulsifiers and surfactants. PPC is the most abundant phospholipid component of cell membranes, a precursor to acetylcholine, and a constituent of lipoproteins. PPC works to disrupt the membrane of fat cells through the release of lipids. DCA is a bile salt that helps emulsify and break down fat as well as maintain PPC solubility for injection.
Currently, Kybella is the only FDA-approved fat-dissolving injectable drug. Its active ingredient is DCA and it is solely approved for reducing fat under the chin in adults.
Physicians may order individualized prescriptions from a compounding pharmacy designed for a specific patient for the purpose of injection lipolysis. However, there is a risk of FDA investigation and sanctions involving compounded drugs that are not approved by the FDA.
Safety and Efficacy of Injection LipolysisAny clinical study involving subcutaneous injection of these drugs requires Food and Drug Administration (FDA) approval of an investigational new drug (IND) application plus approval by an institutional review board (IRB).
Reports of adverse events have been documented following the injection of compounded preparations for injection lipolysis. These adverse events include mycobacterium skin infections, inferior alveolar nerve injury, skin ulcers, panniculitis, alopecia, nausea, diarrhea, and dizziness. The depth of injection lipolysis is critical to prevent damage to the underlying fascia layer.
The U.S. Food and Drug Administration has specifically noted significant risks associated with unapproved fat-dissolving injections.
Patients should be advised that unapproved fat-dissolving injections have been associated with serious complications. These include permanent scarring, severe infections, skin deformities, cysts, and painful knots. Many of these adverse reactions have occurred when injections were administered by improperly licensed personnel or when individuals attempted to inject themselves with products purchased online.
Recommendations Regarding Injection LipolysisInjection lipolysis is typically performed using FDA-approved products or with proprietary formulations provided by compounding pharmacies. The Board only supports injection of medications which are FDA-approved for injection lipolysis. While Board licensees are authorized to prescribe medications consistent with the established standards of care, regardless of approval by the FDA, they should avoid prescribing medications that have little scientific evidence. Licensees should be aware and inform patients of possible side effects before administering and prescribing any medication.
Healthcare providers should emphasize to patients that safe and effective use of these products depends on correct injection techniques, proper needle placement, and professional administration. Patients should never purchase ingredients for unapproved fat-dissolving injections or attempt to inject themselves.
-Adopted October 2007; Amended October 2, 2025