Latha P. and Vandana K.R. / International Journal of Advanced Pharmaceutics / 1 (1), 2011, 19-29.

International Journal of

Advanced Pharmaceutics
www.ijapjournal.com

MESOTHERAPY A REVIEW
* P. Latha and K.R.Vandana
*SreeVidyanikethan College of Pharmacy, Tirupati-517102, Andhra Pradesh, India.
ABSTRACT
Mesotherapy involves multiple intradermal or subcutaneous injections of a mixture of compounds (plant extracts,
homeopathic agents, pharmaceuticals, vitamins, and other bioactive substances) in minute doses, using very fine gauge
needles, to treat medical (mainly local) and cosmetic conditions. The proposed mechanism of action of mesotherapy is that
solutions that are injected intracutaneously remain in the area longer than they would if delivered via deeper injection because
they are cleared more slowly by the general circulation. In addition, it is felt that these superficially injected solutions continue
to penetrate into the deeper tissues. The more superficial the injections, the longer the solution remained in the area.
Mesotherapy proponents base their claims that mesotherapy is safer than liposuction on the fact that mesotherapy is a
nonsurgical procedure. However, liposuction is FDA-approved and -regulated, while many uncertainties surround
mesotherapy.
Keywords: Mesotherapy, mechanism of action, Mesotherapy Injection Techniques.
INTRODUCTION
The term 'meso' also means 'middle' and 'mean',
hence variably explained with reference to the injection
route (into the middle layer of skin or 'intradermotherapy')
and the mean dose of the medication used (dose in
between allopathy and homeopathy). Mesotherapy
involves multiple intradermal or subcutaneous injections
of a mixture of compounds (plant extracts, homeopathic
agents, pharmaceuticals, vitamins, and other bioactive
substances) in minute doses, using very fine gauge
needles, to treat medical (mainly local) and cosmetic
conditions. The term mesotherapy was suggested by Dr.
Pistor (Father of mesotherapy) in1958. The prefix mesooften raises some questions. For the author, his therapy
was only effective on derivatives of the mesodermis,
however, the effect on the tissues of the mesodermis is so
important that these treatments deserved the global name
of mesotherapy (vessels, tendons, conjunctive tissues) [1].

Corresponding Author:-P. Latha

Mesotherapy does not denote a treatment of any

condition in particular; it simply describes a method of
drug delivery.
Mesotherapy is a medical technique
1. Performing it requires medical knowledge and
practice
2. An accurate diagnosis is essential, using clinical and
instrumental(?) tests
3. The efficacy of the treatment is not linked to the
amount of drug given but to the choice of drug
4. This requires precise pharmacological criteria
Mesotherapy requires
1. A sensible indication
2. A correct clinical assessment
3. Flawless technology
4. Proper technique
5. Suitable drug combinations

Email:-lathaudayan94@gmail.com

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Mesotherapy is one of many treatment modalities

that we should master in order to be accomplished
cosmetic medicine practitioners.
MECHANISM OF ACTION
It has been suggested that the skin acts as a
natural time-release system when drugs are injected by
mesotherapy. The proposed mechanism of action of
mesotherapy is that solutions that are injected
intracutaneously remain in the area longer than they would
if delivered via deeper injection because they are cleared
more slowly by the general circulation. In addition, it is
felt that these superficially injected solutions continue to
penetrate into the deeper tissues. The more superficial the
injections, the longer the solution remained in the area [2].
Mesotherapy Injection Techniques
Each session of mesotherapy involves superficial
injections of medications using specialized short needles
and specific techniques directly over the sites of the
affected structures. Several hundred injections are given,
though the number may vary depending upon the
indication. In general, 1-3 sessions in acute cases, such as
sports injuries and 10-15 with maintenance sessions every
6 months or a year for chronic conditions such as
''cellulite'' may be required.
Commonly three different techniques are used.
1. Point by point
First described by Dr. Pistor, involves injection
of 0.02 ml to 0.05 ml of drug solution perpendicular to the
skin (4 mm deep), given 1 cm to 2 cm apart.
2. Nappage (French for "covering")
Involves more superficial (2 mm deep) injections
with a 4-mm needle, covering a large area. Injections are
given at a 45 degree angle from the skin while applying
light, constant positive pressure on the plunger, the
practitioner rapidly flicks the wrist (mimics shaking a salt
shaker or the action of a sewing machine). At each site, a
drop of solution is introduced. Relatively, this is a more
discomforting procedure to the patient [3].
3. Epidermic
The most superficial (1 mm deep) of all the
techniques in which the basal layer of skin is not
penetrated. Needle size of 27 to 31 gauges is used with the
bevel oriented away from the skin and dragged along with
light, positive pressure applied to the plunger. It is done in
a grid pattern at 1-cm intervals over the entire affected
area. Multiple injections of small doses of medications, in
precise locations, in a single sitting are highly demanding
to the therapist. To overcome this difficult task, many
practitioners in Europe and South America use a device
called 'mesogun'. The benefits of mesogun include faster
injections, precise dose delivery, consistent depth of

penetration and more comfort for the physician and

patient. Some experts use a special technique [4].
USES
The medical benefits include improved blood flow to
the area, dissolving excess fat deposits, removing fibrotic,
hardened connective tissue and improving lymphatic
drainage.
It is highly effective in treating arthritis, joint and
liver disorders. By puncturing the skin and injecting a little
medication right below the surface in the affected area,
(the needles used are only between 0,16 and 0,51 inches
long), the substance does not have to pass through the
blood, the liver and the stomach, resulting in the desired
effects being far more powerful and quickly obtained.
Mesotherapy in cellulite patients
Celluliteis a condition where collections of fat
push against the connective tissue causing cosmetically
unacceptable lumpy, dimpled appearance of skin
resembling cottage cheese.
Cellulite treatment
Mesotherapy is a technique that can be used to
treat cellulite. Keep in mind the following:
There are four stages in the treatment for cellulite
1. Reducing lipoedema
Use benzopirone plus procaine
2. Restoring efficient microcirculation
Use derivatives of the flavonoids, which offer a
particularly beneficial vasculo-protective effect
Pentoxiphylin
Vitamin C is essential for neutralizing the effects of
free radicals generated in the newly oxygenated tissue
Procaine
3. Lipolysis
use Theophylline + Caffeine + L-Carnitine +
Yohimbine+ Procaine
4. Restructuring and protecting the connective tissue
Silicium (Conjonctyl) stimulates the regeneration of
connective tissue
A cellulite mesotherapy treatment requires at
least 3 months time. In treating cellulite, for better
clinical results, it is important to use a combination of
different techniques, including mesotherapy. To be
effective, these techniques have to work first on the extra
cellular matrix, the microcirculation (arteriolar, capillary,
venous) and the lymphatic system, and finally, on the fat
tissue [5].

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The approved use for pentoxifylline is for the

treatment of intermittent claudication. The drug improves
microcirculation by decreasing the bloods viscosity and
by improving erythrocyte flexibility. Pentoxifylline has
been shown to increase leukocyte deformability and
inhibit neutrophil adhesion and activation. Tissue oxygen
levels have been shown to significantly increase with
therapeutic doses of pentoxifylline in patients with
peripheral arterial disease. Mesotherapists believe that by
increasing microcirculation of localized tissue beds, the
elimination of metabolic waste is facilitated. Injecting
pentoxifyllinemesotherapeutically is believed to exercise
the drugs therapeutic effect for a longer period of time
compared to other routes of administration [6].
For cellulite treatment and localized fat reduction,
practitioners use compounds that efficiently remove fat
from cells and move this fat into the general circulation, to
be burned during metabolism or excreted.
Phosphatidlycholine, or lecithin, is one such
compound, and is widely used.
Caffeine, L-carnitine and the asthma drug
aminophylline are other compounds used for fat reduction.
Natural compounds such as artichoke stimulate
lymphatic flow to remove fat.
Tiratricol, a drug that was originally developed to
treat some types of thyroid cancer, is also an efficient fat
burner.
Hyaluronidase and collagenase disintegrate the
bands of fibrous tissue formed between fat lobules in
cellulite. Glycolic acid exfoliates the skin (peels). Vitamin
A regulates cell turnover of skin and keratinization;
Vitamin C enhances the synthesis of collagen and reduces
hyperpigmentation as it inhibits melanin production;
Vitamin E, an antioxidant, aids in anti-aging of the skin;
Vitamin K affects clotting mechanisms and thus regulates
the microcirculation of the skin; DMAE cause myofibril
contraction and smoothen the lax skin; while trace
elements are important for regulating turnover and repair
of skin cells.
Mesotherapy provides a route of administration
that allows for delivery of low doses of medication with
minimal complications. In Europe and South America,
many practitioners choose to use mesotherapy guns for
injections. The benefits of using mesotherapy guns
include:
1. Speed: Faster than manual injections
2. Precision: Delivers precise doses of medication per
injection
3. Consistency: Achieves the same depth of penetration
on each injection
4. Comfort: More comfortable for the physician and
patient

Unwanted fat removal and skin rejuvenation

Mesotherapy, when used for skin rejuvenation,
infuses the dermis with potent vitamins and anti-oxidants
to rejuvenate and revitalize the skin. The results are skin
that is firm, radiant, youthful and glowing. Initially a
series of 2-4 treatments are performed a week apart.
Results are maintained by twice a year touch-up sessions.
When the correct cocktail is used and injected into the
dermis it is an effective skin strengthener. The vitamins
stimulate collagen and hyaluronic acid stimulates new cell
growth. Simply by puncturing the skins surface blood
growth factors are released which stimulate new cell
formation. The fat beneath the skin melts and shrinks the
fat cells in the Scarpas fascia layer. The fat dissolves and
is excreted by the kidneys. A series of treatments (5-15) is
given, spaced one week apart. Results are considered
permanent as long as the patient adheres to a proper
nutrition and exercise regimen. Occasional touch-ups may
be required [7].
Many patients who develop unevenness, divots,
or lumps after undergoing liposuction find that these areas
can be successfully treated with Mesotherapy. The scar
tissue that forms under the skin after liposuction is directly
targeted and dissolved. Doctors are even combining
Mesotherapy withEndermologieto maximise the results.
Most of the conditions treated such as cellulite and
wrinkles have multifactorial causes and due to this it is
necessary to use multiple ingredients to treat the condition
effectively. For mesolifts or facelifts using mesotherapy,
several drugs are available for injection under facial skin
to improve skin tone and reduce the appearance of
wrinkles [8].
Estrogen derivatives such as 17 B-estradiol stimulate
new collagen formation.
Glycosaminoglycans are a natural compound that
forms linkages between collagen fibers.
Naturally occurring alpha hydroxy acids such as
glycolic acid are also used for mesolifts.
The drugs found to be very effective in the
elimination of unwanted fat deposits and skin rejuvenation
include
phosphatidylcholine
(PC),
L-carnitine,
aminophylline, hyalorunidase, collagenase, glycolic acid,
retinoic acid, multivitamins (A, D, E, K), trace elements
[minute quantities of zinc, copper, selenium, chromium
and
manganese],
an
acetylcholine
analog
dimethylaminoethanol (DMAE), lidocaine etc.
Mechanism
The proposed mechanisms for the various
compounds in removal of unwanted fat are as follows. PC
has lipolytic activity by affecting the permeability of the
adipocyte membrane and subsequent fat mobilization.
Some add small quantities of sodium deoxycholate

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to increase the fat-dissolution effectiveness of PC through

disintegration of adipocytes. Thyroid preparations,
aminophylline and isoproterenol are supposed to stimulate
insulin release which helps in breaking down of fat cells
[9].
Pain
Mesotherapy was traditionally employed for pain
relief, in conditions like fibromyalgia, gout, headache,
neuralgia,low back ache, sports injuries (i.e., sprains,
strains, bursitis, tendinitis),and dental procedures.The
procedure involves multiple small volume injections of an
analgesic i.e. NSAID (commonly piroxicam or ketorolac),
surrounding the painful area e.g. inflamed tendon. Skeletal
muscle relaxants like baclofen or diazepam are also
commonly co-administered. Another widely employed
drug in France, for chronic pain disorders, is salmon
calcitonin (sCT) which is already used in conventional
medicine as an analgesic in painful bone disorders ranging
from osteoporosis to cancer [10].
NSAID
The subjects were divided into three groups.
The first group received intraepidermic papules of a
diluted NSAID,
The second group received subcutaneous injections of
the same solution using 4mm needles, and
The third received deep intramuscular injections of
the same solution.
At 1 and 3 hourspost injection, venous blood
draws were performed to determine serum levels of the
NSAID. It was found that uniformly, the shallower the
injection, the lower the level of the substance present in
venous circulation at both 1 and 3 hours post injection.
Alopecia
Injections of minoxidil, finasteride, lidocaine,
multivitamins, T3/T4 are used in treatment of alopecia. In
house publications and company brochures suggest that
injections of "cocktails" of natural plant extracts,
homoeopathic agents, vasodilators, finasteride and
minoxidil and vitamins are carried out with a mesogun
once in 2-4 weeks. Of these, only minoxidil and
finasteride have an established role in the management of
pattern hairloss. Both the mechanism of action and the
efficacy of other agents are not established and are
doubtful. Further, a recent publication of guidelines on
esthetic practices in Singapore listed mesotherapy as a List
B procedure (List B procedure indicates procedures with
low or very low evidence or local medical expert
consensus that procedure is neither well-established nor
acceptable) [11].
In view of these data, the current position on the
use of mesotherapy in pattern hairloss can be summarized
as follows.

1. Data on its safety and efficacy in pattern hairloss have

not been adequately and critically evaluated and
documented in proper, peer-reviewed clinical trials.
2. Data evaluating the rationale and pharmacology of the
combination of herbal and allopathic medicines used are
not adequate. There are no clear-cut guidelines on the
dosage and efficacy of the products.
No Needle Mesotherapy
It is discomfort for the patients as needles are injected
1cm apart in the entire area. Another way to incorporate
mesotherapy into a spa or salon without a nurse or a
doctor is by using the new no-needle mesotherapy
devices.
No-Needle Mesotherapy Equipment (Beauty Skin
Equipment)
This needle free meso therapy beauty instrument is a new
design for skin care and fat loss.
No-needle Mesotherapy
System Characteristics:
1. No-needle mesotherapy works more effective by
customizing the cosmetic solution according to
characteristic of specific skin.
2. No-needle mesotherapy uses the latest bio-tech
production technology to select the small molecular
weight ingredient that can be rapidly absorbed by skin.
3. No-needle mesotherapy features over 1000 times of
absorption rate comparing with ordinary cosmetic
products by using ultra micropenetration technology with
which effective nutrimental ingredients can directly reach
the most demanding part of the skin.
4. Mesotherapy produces long lasting efficacy, thanks to
th unique bio-packet technology that carries the
biologically active ingredients into skin cells via
capillaries, and gradually release them to continuously
stimulate the cell rejuvenation for lively and youthful skin
[12].
Treatment Range:
1. Dissolve fat quickly
2. Remove wrinkle safely
3. Reduce cellulite
4. Skin whitening and spots removal
5. Complement water and keep moisture
6. Restore skill
Product Description
No-needle mesotherapy beauty skin equipment is
a high-tech and effective alternative to the injection based
mesotherapy method using pulses of electrical energy
especially designed to relieve congested tissue, ours has
the following obvious functions. Four wave shape for

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individualtreatment:Skin rejuvenation, moisture locking,

wrinkles removal and freckles reduction, as well fatness
dissolving, cellulite treatment etc according to different
drug injection. Another four Chinese traditional physical
therapy:Acupuncture, cupping, hypnosis and massage
Delegated to nurse or technician Pain free with no
swelling or bruising Standardized drug cocktails Average
treatment time 30 minutes Body and face treatments. Noneedle Mesotherapy Equipment is high-effect, woundless
and safe treatment, completely removes the traditional
needle and micro-needle injection. It takes electrophoresis,
(introduced into Europe markets in 2000 by the Italy
company, Microlab Biomedical, got FDA approval in
2005, Nobel Prizes Winner in Chemistry in 2007), uses
the electroporation and electroosmosis, by orientation,
layer-oriented, ration to supply nutrition to the deep-seated
cells, assist to melody the muscale, lymph drainage,
promote metabolism, lymph and blood circulation, so as to
decrease, wrinkles, whiten skin and keep moisture,
improve cellulite, quicken fat dissolving and weight loss.
Comparing it with the single skin care products,
effectively absorb products higher 2000 times, thoroughly
solve the problem of products only staying in the
epidermis, can keep skin young for a certain term and
shorten the period of treatment. No-needle Mesotherapy is
truly the brightness of beauty equipments in 2008 [13].
FEATURES
Solve 3 troubles in beauty field
1. With no use any injectors, by orientation, layeroriented, ration, to transmit many kinds of nutrition into
deep-seated cells, let skin whitening, wrinkle and freckle
removal and skin thinning at one-step.
2. The absorption effect is higher over 2000 times than
the traditional skin care products.
3. It can be designed by the customers original liquid
containers, let the equipment match with the skin care
products, very special.
Features
1. Greatly enhance penetration of natrual substance into
skin
2. RF enhances the face contour result, which is
solidified by LED
3. Provide wide applications according to different
cosmetic products
4. Touch screen, set operation time freely
5. Upgradable platform
Mechanism
FUSION MESOTHERAPYis a new concept in
non-invasive aesthetic medicine. A new mesotherapy
approach based on breakthrough systems and products.
Fusionmesotherapy(needle-free)isa radio

frequency (RF) based device.It enhances the transdermal

transport of topical products, through the epidermis to the
dermis. The radiofrequency (RF) produces a cellular
electroporation reducing the permeability of the skin and
opening cellular pores. At the same time the radiofrequency (RF) increases the skin temperature of 5 to 7C
to stimulate the collagen synthesis and skin tightening.
Fusion mesotherapy, consists in combining sub-cutaneous
injector (conventional mesotherapy MESO-PEN device)
and the radiofrequency (RF) device. This technique
improves the effectiveness of injected products and the
results. It has been demonstrated by clinical study to be
very effective for lipolysis offering a real alternative to
plastic surgery lipoplasty and lipo-lasers [14].
Main indications: Skin rejuvenation, expression
wrinkles, wrinkles, skin tightening, whitening, acne, anticellulite, lipolysis, sport medicine etc. Electroporation and
Electroosmosis Electroporation: Directly act on the skin,
instantly enhance skin tissue penetration. Under the
function of electroshock, there will be formed holes in the
lipid mobilization of cells, at the same time, the
hydrophile molecule which have not been absorbed
originally can penetrate into cells inner. Once the holes
forming, withing several seconds to several minutes, it
will keep the opening state according to the length of
electroshock.
Electroosmosis: Mainly act on the substance
molecule which will be dispersed, help it freely to
penetrate into skin inner. Same quality electric charges are
mutual repulsion, so it can throw positive current onto
positive nutrition molecule, push untritin molecule into
skin tissues. At the same time, the neutral molecule also
will penetrate into skin inner [15].
ADVANTAGES OVER OTHER THERAPIES
When taken orally, the liver and stomach will
destroy part of the drugs and other parts will diffuse
everywhere in the body, which can cause undesired side
effects and only a small amount will arrive in the required
area. Furthermore, the amount of medication, either
conventional or homeopathic, to be used can be greatly
reduced; the quantity injected can be as little as only 1%
of the quantity used in normal treatments, which again
reduces the side-effects and also avoids the body
becoming resistant to certain drugs.
The combination of vitamins, herbal products and
medication that is injected is tailored specifically for each
patient to optimize results. Many factors are taken into
consideration to determine the most effective combination
including genetics, gender,liposuction, type of fat, age and
medical history [16].

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The FDA and Mesotherapy: A Shaky Relationship

The FDA and mesotherapy have had a shaky
relationship throughout the years. Mesotherapy was a
popular procedure in Europe long before it came to the
United States. However, since it arrived in the US in the
1990s, it has been riddled with doubt towards its
effectiveness and safety. The Food and Drug
Administration, or the FDA is the organization that
approves the food and drugs that we use and assures that
they are safe for use. It is important to note that FDA and
mesotherapy have not come to common terms with each
other - the FDA has not approved mesotherapy, although it
has the support of some very influential dermatologists
[17].
Many of the drugs used in mesotherapy were not
created especially for their mesotherapeutic purposes. For
example, the commonly use drug in mesotherapy
injections, Aminophylline, was originally approved as a
bronchodilator drug for those with several lung conditions,
such as chronic bronchitis or emphysema. It is used in
mesotherapy as it is proven to help improve blood flow in
patients with respiratory problems and the hope is that it
will do the same with those who have cellulite. Yohimbine
is a commonly used drug approved by the FDA, but not
for mesotherapy. It was actually originally used to treat
erectile dysfunction. It works in a manner similar to
aminophylline, as it causes vasodilation, thus increasing
blood flow. It is believed that increased blood flow
reduces fluid retention, and reduced fluid retention can
possibly lead to less cellulite [18].
Procaine is another very popular drug used in
mesotherapy. It is a local anesthetic also known as
novocaine and is used to relieve the burning and itching
sensations that sometimes come with mesotherapy
injections. Other anesthetics used in mesotherapy include
lidocaine and marcaine, both which are also FDAapproved. They are used in hospitals and are injected in
patients with pain, the same purpose it holds in
mesotherapy. However, anesthetics can be deadly when
the proper precautions are not taken, so make sure any
local anesthetic that is injected during mesotherapy is
under the supervision of a certified doctor or nurse. Other
compounds do not have FDA-approval for any sort of use,
as they are not considered drugs and are thus beyond the
scope of the FDAs regulation. This includes vitamins and
minerals, such as those found in the local pharmacy.
Mesotherapy practitioners often use liquid solutions of
these compounds and inject them directly into the skin
[19].
L-carnitine, a drug used in mesotherapy, is FDAapproved, not recommended for those who are pregnant or
nursing; not advised for those with impaired kidneys. It is

naturally present in the body as a fat-burning component

of metabolism [20].
Biotin is actually a type of B vitamin sometimes
called vitamin H or B7. It is a water-soluble nutrient and
even though it is usually left out of Nutrition Facts labels,
it is essential for cell growth and metabolism of fats and
amino acids. It is also sometimes used in mesotherapy,
although it is not approved (not considered a food or a
drug) [21].
Minoxidil is another drug FDA-approved for
topical use. This drug is actually the generic name for
Rogaine. The product used by men (and women) who are
losing hair. It is part of a not-too common method of
mesotherapy that involves injecting minoxidil into the
scalp with a Skin & Scalp Roller (a medical instrument) to
encourage hair growth [22].
Unlike many other drugs used in mesotherapy
which are approved for oral consumption, retinoic acid has
FDA-approval for topical treatment. It is widely used in
beauty products because it has been proven to be an
effective tool against numerous skin problems, from acne
to wrinkles. A similar compound, alpha lipoic acid is also
approved for topical use; however the FDA has warned
that it often leads to increased sensitivity of the skin to the
sun.
Phosphatydlcholine is one drug used in
mesotherapy that the FDA actively lobbies against,
because it is a drug that the FDA is able to regulate and is
not approved by the administration for any sort of use.
Despite this, it is still a very popular component in many
mesotherapy kits, sold under the name Lipostabil. It is also
commonly abbreviated as PC or PPC.
ASPS Guiding Principles for Mesotherapy
The terms "mesotherapy" and "injection
lipolysis" are often used interchangeably. While somewhat
different, both therapies are advertised as a non-surgical
alternative to liposuction. As the promotion and popularity
of mesotherapy and injection lipolysis has increased, so
too has the controversy surrounding their use. Questions
regarding the safety and efficacy of these therapies and
whether or not their use is in violation of federal or state
regulations abound. Before pursuing mesotherapy or
injection lipolysis use in a practice, plastic surgeons
should be aware of, and carefully consider, the numerous
medico-legal aspects associated with these therapies.
1. Background
Originally developed in Europe, mesotherapy is a
general term describing a technique that utilizes a series of
injections
of
pharmaceutical
and
homeopathic

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medications, plant extracts, vitamins, and other ingredients

into subcutaneous fat. While mesotherapy has been touted
for the treatment of a wide variety of ailments, one of its
notable indications is for dissolving localized fat
accumulations. The term injection lipolysis is used
specifically in reference to the practice of injecting various
phosphatidylcholinedeoxycholate
formulations
into
subcutaneous fat deposits. The injections are generally
administered over multiple treatment sessions. There are
no standard formulations for either mesotherapy or
injection lipolysis.
2. Regulatory Environment
Food and Drug Administration (FDA)
Approval:Currently, there is no known PDA-approved
injectible solution or pharmaceutical preparation for
mesotherapy or injection lipolysis. Thus, physicians who
wish to perform this therapy for adipose reduction may be
subject to some degree of liability as the FDA may review
individual occurrences on a case-by-case basis for
enforcement action.
Compounding:The FDA regulates drugs bought
and sold in the United States as well as establishes
protocols for compounding drugs, the process of mixing
drugs by a pharmacist or physician to meet the unique
needs of a patient. Phosphatidylcholine and sodium
deoxycholate are both FDA approved for uses other than
mesotherapy or injection lipolysis. However, the legality
of compounding them for the purpose of injection lipolysis
is controversial, because combining phosphatidylcholine
and sodium deoxycholate would produce a "new drug"
that is not approved by the PDA for subcutaneous
injections. As part of a statement issued February 1, 2008,
the PDA clearly stated that most compounded drugs are
not PDA-approved drugs. 1 Physicians pursuing this
compounding approach to administer injection lipolysis
may be subject to enforcement actions by the PDA if their
practices do not meet the criteria outlined in the PDA
Compounding Compliance Policy Guide.2 In addition,
medical providers and pharmacists are bound to adhere to
State regulations governing compounding, which are
determined by individual state regulatory bodies.
Off-label Use:Compounded drugs should not be
confused with the "off-label" use of drugs. PDA approval
of a drug indicates use of the drug for a specific purpose.
Once a drug is approved by the PDA, a licensed physician
may prescribe a drug for uses other than the indicated
purpose, provided there is scientific evidence / literature to
support such use. However, because the mixture of drugs
and other ingredients in mesotherapy formulations
produce a new drug that is not PDA approved for any
purpose, its use would not be considered "off-label" use.

State Regulation:The PDA shares regulatory

authority over the use of drugs with individual states. Both
Kansas and Nebraska have taken steps to limit the
utilization of mesotherapy by physicians. On March 12,
2008, the Kansas Board of Healing Arts voted to prohibit
use of phosphatidylcholine and/or sodium deoxycholate
unless part of an PDA-sanctioned clinical trial or an
individualized prescription from a compounding pharmacy
for a specific patient. The ban also prohibits bulk
purchases of the products. On February 19, 2008, the
Nebraska Legislature introduced a bill that prohibits the
administration
of
subcutaneous
injection
of
phosphatidylcholine or sodium deoxycholate, or any
combination of the substances for the purpose of
eliminating or reducing local fat accumulation. Upon its
recess in April 2008, the Legislature indefinitely
postponed the bill.
3. Scientific Evidence
There is very limited scientific evidence available
on mesotherapy or injection lipolysis for fat reduction. A
thorough search of the literature found 14 references for
mesotherapy for fat reduction or injection lipolysis. Based
on a critical appraisal of the relevant literature, the
majority of articles were found to be levels IV and V, the
lowest levels of validity for scientific studies. Three of the
fourteen articles were not rated due to the fact they were
too poorly designed; and, were therefore rated to be of low
quality. 3-15 Furthermore, these studies do not offer
comparable information on formulations and dosages of
key ingredients, which are two elements necessary to
compare safety and efficacy of treatments. The low levels
of validity and quality of the literature does not allow
ASPS to support a recommendation for the use of
mesotherapy/injection lipolysis for fat reduction [23].
4. Guiding Principles
It is the individual physician's responsibility to
understand and abide by all applicable Federal, State, and
local regulations.
Only PDA-approved uses of drugs may be
commercially advertised; it is illegal to commercially
advertise any non-approved or off-label use.
Each physician must ensure that a means for
providing the appropriate informed consent for each
patient has been established prior to the treatment. The
consent should include the fact that there is very limited
scientific evidence available to verify the efficacy of
mesotherapy and/or injection lipolysis for the treatment of
dissolving fat accumulations.
Because safety and efficacy cannot be ascertained
from the available body of English literature, ASPS

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Latha P. and Vandana K.R. / International Journal of Advanced Pharmaceutics / 1 (1), 2011, 19-29.

believes further scientific testing of fat reduction

mixtures is needed before recommendations on their use
may be formally issued.
Physicians administering mesotherapy treatments
should be aware of the chemicals/drugs being injected,
dosages, particular side effects, and potential interactions.
Records of injected substances and dosages
administered should be available in the patient's medical
record and accessible to other treating physicians.
When interpreting and applying these guiding
principles to their individual practice, physicians should
use their personal and professional judgment.
These guiding principles should not be construed as a
rule and are not meant to serve as the standard of medical
care.
Common Complicationsand Adverse Reactions in a
Mesotherapy Practice
Mesotherapy complications may be broken down
into 3 categories: untoward reactions to pharmaceuticals,
pigmentation problems, and necrosis Allergic reactions to
biologicals are seen fairly often. The enzymes
hyaluronidase, collagenase, and phosphatidylcholine are
the only drugs causing allergic reactions that we have
seen. Hyaluronidase can create a wheal and flare reaction
of the immediate or delayed hypersensitivity type. In the
immediate type, the reaction is seen within 15 minutes and
consists of a raised, erythematous wheal that is intensely
pruritic. A skin test will reveal this immediate
hypersensitivity reaction before the patient undergoes a
treatment containing hyaluronic acid. The delayed
hypersensitivity reaction to hyaluronidase has the same
appearance but may not reveal itself until after multiple
treatments. As many Hymenoptera contain hyaluronidase
in their venom, an allergy to these insects should alert the
mesotherapist to the likelihood of a wheal and flare
reaction occurring when this ingredient is used.
Collagenase hypersensitivity may also be seen
either in the immediate post-treatment period or as a
delayed reaction. It presents as a series of raised patches
that are tender to the patient but not pruritic.
Phosphatidylcholine allergy is much less likely but has
been seen after an initial treatment. It appears as a fine,
pruritic, maculopapular rash distant from the treated area.
In all these allergic instances the reaction responds to
parenteral or oral diphenhydramine in dosages of 25-50
mg. A protocol we have used is 25 mg of
diphenhydramine every 6 hours for 2 days along with 30
mg of prednisone initially, followed by 5 mg of
prednisone every 6 hours also for 2 days. When a patient
has an allergy to hyaluronidase, collagenase, or
phosphatidylcholine, pretreatment beginning the day
before mesotherapy with 5 mg of prednisone followed by
10 mg of prednisone on the day of the treatment has
prevented or severely reduced the reactions. Occasionally,

in
a
patient
pretreated
with
corticosteroids,
diphenhydramine will also be required following
treatments if there is continued pruritus.
Aminophylline is commonly used in adiposesculpting mesotherapy formulae. This drug has a narrow
therapeutic index with problems encountered at dosages
around 250 mg in most patients. Nausea, vomiting and
diarrhea are the most common complaints with onset
occurring 4 to 8 hours postprocedure.3 When serum levels
increase to greater than 20 mg/mL cardiac arrhythmias and
seizures are possible.3 Repeated dosages of aminophylline
may also decrease serum potassium over time.3 In patients
with risk factors for potassium wasting, this electrolyte
should be monitored, and any patient experiencing muscle
cramping should have this electrolyte assayed
immediately. Some mesotherapists will administer a preprocedure parenteral anti-emetic in select patient
populations. Hyperpigmentation problems status postmesotherapy procedures have also been noted. In the highmelanin Fitzgerald skin types V and VI, postinflammatory hyperpigmentation has occurred. Topical
preparations containing, singly or in combination, kojic
acid, hydroquinone and/or glycolic acid have been helpful
in resolving this unfortunate complication over months. Of
greater concern, and which may occur irrespective of
Fitzgerald skin type, is urticariapigmentosa. We have seen
this only following wheal and flare reactions in the skin.
In the resolution of the wheal, a purplish to brownish
discoloration appears in the subcutis and remains for
months despite all efforts to eradicate it. Over time these
have gradually improved, but we have found no way to
hasten their resolution. Hyperpigmentation of any type is
not common in our practice, the incidence being 0.87%.
Nonetheless, pigmentation problems, although not serious,
can be very distressing to patients.
In summary, hypersensitivity reactions are
common and easily managed. Adverse drug reactions,
although not frequent, may also be anticipated or treated
with common-sense protocols. Hyperpigmentation
complications are not medically serious, but many patients
become concerned when these develop and wish to
discontinue treatment. Tissue necrosis is rare, but serious.
With attention to appropriate drug selection and delivery
protocols, mesotherapists are unlikely to encounter this
situation [24].
Dangers of Mesotherapy
If you're desperate to lose fat from one stubborn
area, or if you're tired of trying to hide your cellulite,
mesotherapy may seem like the answer. Many people
claim it's a miracle cure for fat. However, you should be
wary of so-called miracles. Mesotherapy is unregulated,
and the American Society of Plastic Surgeons warns that it
could be dangerous.

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Latha P. and Vandana K.R. / International Journal of Advanced Pharmaceutics / 1 (1), 2011, 19-29.

1. Identification
Mesotherapy is a nonsurgical treatment to
remove fat. Proponents call it an alternative to liposuction.
Mesotherapy treatments begin by discussing your goals
with your doctor. He then creates an individualized
mixture of medicines and plant extracts to inject into the
layer of fat tissue during your mesotherapy sessions. The
mixture removes fat cells and evens out cellulite.
You'll receive between three and 15 sessions of
mesotherapy, given every other week, before your
treatment is done.
2. Benefits
Those who support mesotherapy claim it is both
safer and cheaper than liposuction, which is currently the
only other medical method to remove fat cells from the
body. It can be done in a doctor's office, and the recovery
time is shorter. It also provides help for those whose
weight problem isn't bad enough to be eligible for
liposuction. Mesotherapy reduces cellulite as well, while
liposuction doesn't.
3. Side Effects

The most prominent side effect of mesotherapy is

swelling and bruising around the area of the injections. In
most cases, this goes away within a week or so. Some
people have allergic reactions to the medications used,
either immediately or later. You may see skin
discoloration or a rash. Mesotherapy can also cause
infection.
4. Dangers
Mesotherapy is not regulated by the U.S. Food
and Drug Administration, and the FDA has not approved
many of the drugs used in the procedure. A different
combination of drugs is used for each patient, so it can be
difficult to test the treatment's efficacy. The Device and
Technique Assessment Committee of the American
Society of Plastic Surgeons warns patients to be cautious
about mesotherapy until more testing can be done. No one
is sure what happens to the fat cells after they are
removed, and no one is sure what effect the mesotherapy
drugs have on the rest of the body's systems. Mesotherapy
methods are not standardized, and long-term effects
haven't been studied [20,24].

Fig1.Mesotherapy - Face after treatments

Fig 2.Mesotherapy Targeted fat cells

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Latha P. and Vandana K.R. / International Journal of Advanced Pharmaceutics / 1 (1), 2011, 19-29.

Table 1. Mesotherapy and LipoDissolve Ultra Treatments

Mesotherapy/ LipoDissolve Ultra is a non-surgical treatment to help dissolve unwanted areas of fat tissue ... similar to
liposuction but without the surgery and downtime.

LipoDissolve Ultra can effectively treat areas such as the

flanks (love handles), the lower tummy "pouch" just below
the belly button, upper hips, and upper outer thighs (saddle
bags), upper arms, double chins and jowls.

Pre-treating the area with an ultra-sound massage increases

the fat cells' receptivity to the LipoDissolve Ultra treatment
solution.

When micro injections of the mesotherapy-LipoDissolve

Ultra solution is administered into the targeted area, the
solution is quickly absorbed into the fat cells.

Immediately after treatment, the target areas are once again

treated with ultrasonic massage for increased comfort, to aid
in even distribution of solution and to minimize post
treatment edema.

Within the target areas, the treatment causes fat cells to

dissolve.

The dissolution products of the fat cells are removed in a

natural manner, similar to the way blood is removed within a
bruise. Inflammation of the overlying skin causes the skin to
retract, tighten and become smooth. Fat cells that are
dissolved by the process are permanently lost.

pg. 28

Latha P. and Vandana K.R. / International Journal of Advanced Pharmaceutics / 1 (1), 2011, 19-29.

CONCLUSION
Mesotherapy proponents base their claims that
mesotherapy is safer than liposuction on the fact that
mesotherapy is a nonsurgical procedure. However,
liposuction is FDA-approved and -regulated, while many

uncertainties surround mesotherapy. Proponents' claims

that mesotherapy is cheaper than liposuction aren't
necessarily true, either. Mesotherapy costs between $1,000
and $1,500 per session; depending on how many sessions
you need, that can quickly add up to the cost of surgery.

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