Background
Treatments most properly called “injection lipolysis” have been commonly associated with the term “mesotherapy” to reduce or eliminate unwanted local accumulations of fat. Various terms for treatments that purport to “dissolve” fat seem to be used interchangeably, although “mesotherapy” has gained prominence in the public vernacular.
Injection lipolysis is typically done with trade-named products such as Lipodissolve™ and Lipostabil™ or with proprietary formulations provided by compounding pharmacies. The one common ingredient in all injection lipolysis formulations is phosphatidylcholine (PPC).
In the United States, sodium deoxycholate (DC), a constituent of bile, is a second major ingredient used to keep the PPC soluble and in an injectable form without precipitating out of solution.
Phosphatidylcholine (PPC) and sodium deoxycholate (DC) are both phospholipids, emulsifiers, and surfactants. PPC is the most abundant phospholipid component of cell membranes, a precursor to acetylcholine, and a constituent of lipoproteins. DC is a constituent of bile. Both substances are naturally present in the human body.
In contrast to injections into the mesoderm, injection lipolysis treatments are delivered into the subcutaneous fat. In both cases, the depth of injection is critical to prevent damage to fascia. It has been hypothesized that treatment with PPC and DC reduces subcutaneous fat by adipocyte necrosis due to direct toxic or surfactant effects.
Phosphatidylcholine (PPC) and sodium deoxycholate (DC) are both approved by the U.S. Food and Drug Administration (FDA) for use as surfactants and drug carriers, among other applications, but neither is approved for subcutaneous injection. Lipodissolve™ and Lipostabil™ are not approved by the FDA.
Proprietary formulations of PPC / DC and other drugs have been manufactured by compounding pharmacies, yet such formulations lack standardization in terms of good manufacturing practices and sterility.
The FDA is well aware that injections to reduce fat deposits are performed, but the agency thus far has not exercised its enforcement power to restrict the use of compounded PPC / DC.
Safety and Efficacy of Injection Lipolysis
To date, reports on the safety and efficacy of injection lipolysis have been anecdotal. Any clinical study involving subcutaneous injection of these drugs requires FDA approval of an investigational new drug (IND) application plus IRB approval.
Reports of adverse events, including mycobacterium skin infections have been reported following the injection of compounded preparations for injection lipolysis.
Recommendations Regarding Injection Lipolysis
Patients must be informed that this procedure uses compounded drugs that are not approved by the FDA for injection.
The use of a PPC/DC combination is permitted in the context of a clinical trial operating under a FDA-approved IND (investigational new drug) study protocol.
Physicians may order individualized prescriptions from a compounding pharmacy designed for a specific patient for the purpose of injection lipolysis. “Bulk” purchases of the compounded drugs will not be possible. There is the risk of FDA investigation and sanctions involving compounded drugs that are not approved by the FDA.
Lipodissolve™ and Lipostabil™ are not approved by the FDA. It is illegal to import or use them.
-Adopted October 2007