Is Lipodiisolve Safe?

The American Society of Aesthetic Lipodissolve [ASAL]
objects to the inclusion of "Lipodissolve" in the recent
warning against injection therapy (MESOTHERAPY) for
localized fat reduction issued by the American Society of
Aesthetic Plastic Surgery [ASAPS].  The procedure,
Lipodissolve was introduced by the founders of ASAL in 2001
as distinct from "Mesotherapy".

The ASAL took care to include ingredients which were safe
and whose mechanism of action was understood. The ASAL
diligently limited training only to physicians and their
nurses to perform the procedure. The ASAL and its original
cohort, "Network Lipolysis", thus trained more than 300
physician in Europe, and so far, more than 200 physicians
in the United States.   ASAPS is incorrect in stating that
there are no data relative to the effectiveness and safety
of the procedure.

As it relates to Lipodissolve, several thousand treatment
sessions have been reported in European and American peer
reviewed journals demonstrating: a] objective evidence of
improvement, based on actual measurements and pictures, in
approximately 90% of the patients, and b] a paucity of
serious side effects.1-4,6,7 Serious side effects reported
with liposuction such as death, fluid overload, epinephrine
and lidocaine toxicity, thrombosis, fat embolism and
complications of general anesthesia have not been reported
with Lipodissolve therapy.5

The main ingredient in the Lipodissolve formula is
phosphatidylcholine [PC], a lipid. It is dissolved in a
bile salt [deoxycholate], which is how it exists in bile
where it helps to breakdown the ingested fat cells and
digests fat on a daily basis.  When injected in to the
unwanted superficial body fat, it similarly breaks down fat
cells and "digests fat", as it does naturally in proximal
duodenum. In the subcutaneous area the dead fat cells are
then gradually removed by the body's physiologic repair
mechanisms, the same way as after any trauma or even after
liposuction which leaves dead fat cells in the area to be
removed by similar physiologic processes. PC along with
other phospholipids are significant dietary source of
essential fatty acids. Mammalian cell membranes are
primarily composed of PC and other phospholipids mixed with
cholesterol esters and salts to maintain fluidity. In other
words it is not some foreign or toxic substance.

ASAPS's statement that this "procedure is not FDA approved"
is misleading. FDA approves drugs and devices, not
procedures. ASAL maintains that there is no FDA approval
requirement relative to phosphatidylcholine for two
reasons. One, it is a "supplement" and as such has been
used for years for liver health, cholesterol and other
possible benefits. Supplements do not require FDA approval
and can be administered by injection, (as are vitamins and
minerals as in Meyer's cocktail, intravenous nutrition or
hyper-alimentation consisting of amino acids, vitamins,
minerals, lipids, and others. Second, in Lipodissolve, the
ingredients are mixed by a compounding pharmacist upon a
physician's order for specific a patient, which does not
require FDA approval [FDA Modernization Act Section 503a
Compounding Pharmacy]. Lipodissolve is not a surgical
procedure. Accordingly, ASAL has compiled an advisory board
that includes highly credentialed physicians with diverse
but relevant backgrounds in the fields of dermatology,
aesthetic surgery and internal medicine.

These individuals are experienced clinicians, speakers,
writers, researchers and teachers, and provide advice
regarding the procedure and its evolution. They conduct
training workshops for other physicians in the U.S. So far
the North American advisers have performed more than 2,000
Lipodissolve procedures with satisfactory results in more
than 90% of the patients - without any serious side
effects. The ASAL has an on going monitoring process to
record these events.


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Barry A. S. Lycka is one of North America's foremost
authorities on cosmetic, skin cancer, reconstructive and
laser surgery of the skin. He is founder of The Ethical
Cosmetic Surgery Association (http://www.ecsaonline.com )