INTRODUCTION
The struggle to reduce the buildup of undesired adipose
tissue in the human body is a century old.1 After
the revolution brought about by Klein´s liposuction
innovations during the 90’s, development of treatments for
non-localized lipodystrophias blossomed and become wellestablished
while development of localized lypodystrophia
treatments stopped.2,3 A few years later, phosphatidylcholine
and sodium deoxycholate solutions gained recognition for their
great capability for achieving results4,5 and their relatively easy
application. New research results have intensified an already
established discussion6 regarding a mechanism of action that is
not 100% understood, even today.7 Theorization continued8 and
the local vs systemic effects analysis got most of the attention.9
The first effectiveness results started to appear,10 but “off-labelâ€
uses,11 sometimes even reckless, and the use of these products
by non-qualified personnel, undermined society’s confidence in
this kind of procedures.
Today, there is an adipocytolytic solution that has become the
starting point of a new generation of injectable products for
localized fat reduction. It is commercialized in Europe as a medical
device. New evidence for localized adiposity treatments
with sodium deoxycholate surfaces on a daily basis.12,13 However,
the data available is almost exclusively focused on clinical
results.14,15 Other than empiricisms,16 there is virtually no information
of any kind regarding this procedure. In spite of this, it
is important to stress that by the end of 2012 over 120,000 vials
of this product had already been injected in Spain and up to
that moment, to the best of the authors’ knowledge, there had been no reports of ulcers, skin necrosis, or irreversible functional
deficit due to the use of this specific product. The absence
of reports (even if the data is biased to some extent) after such a
huge number of applications suggests that this product is safe.
The primary aims of this study are to a) perform a descriptive
analysis of the side effects that occurred after treatment and
b) to evaluate the effect of the number of vials injected on the
side effects recorded. A secondary aim was to analyze whether
other variables such as gender, body mass index (BMI), age,
number of previous sessions, total number of injected areas,
and number of vials injected in each area may alter the influence
of the number of vials injected on side effects.
MATERIALS AND METHODS
In the present study, 331 sessions on 145 patients who received
treatment between July 1, 2011, and June 30, 2012, were analyzed.
Each patient who fulfilled the inclusion criteria and was treated
during this period was included. Inclusion criteria were as follows:
a) 25-65 years old; b) 19.5-29 BMI; c) no systemic pathologies;
d) not under chronic medication or treatment; e) not pregnant
or breastfeeding; f) no other treatment in the same areas within
a month prior to the first session; g) adipose panicle minimum
thickness: 1.5 cm; h) application areas were limbs and trunk. The
product injected was Aqualyx®, Ghimas S.p.a., Casalecchio di
Reno, Italy. as per the technical specifications.17 Each therapeutic
vial consisted of the 8 ml commercial presentation unit and 0.2 ml
of lidocaine 2% (no epinephrine) added to it. Special 100mm/24G
and 70mm/25G needles were used for injection.
