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Aesthetic Dermatology Fillers
Figure 1: Subcutaneous Hyaluronic Acid Implant Sterilisation of cross-linked hyaluronic acid at 121ºC for 15 minutes
Varioderm Subdermal Three Months After Injection
does not change its properties or chemical composition.
2,3
(Rat 25, Group Three)
Impurities can also be expected in hyaluronic acid due to bacterial
fermentation. The determination of endotoxins is necessary. The
maximum allowed value should be less than 0.5IU/mg.
12
The protein content of hyaluronic acid should be tested in order to
rule out any immunological reactions. The content of nucleic acids
should be determined photometrically at 260nm (purines and
pyrimidines absorbing wave light).
Biocompatibility
When used as a filler, hyaluronic acid products of non-animal origin
have been proved not to have any sensitising effect.
4
An
immunological reaction is not to be expected when using hyaluronic
acid preparations that have been produced by means of bacterial
fermentation.
4
Pathological changes and acute or chronic sensitivity
have been observed after the use of cross-linked hyaluronic acid,
Figure 2: Cross-section of Hyaluronic Acid Gel Implant at with no systemic effects.
5
Animal experiments have confirmed
Low Magnification (Rat 25, Group Three)
that hyaluronic acid cross-linked by divinyl sulphone (DVS) is
compatible with blood.
6,7
Animal experiments with rats, rabbits,
monkeys and guinea pigs conducted over a period of 33 months
showed that cross-linked hyaluronic acid is biocompatible (non-
inflammatory, non-toxic, non-immunising).
13
The immunological
compatibility of the cross-linked acid has been demonstrated mainly
by the fact that the glycosaminoglycan chains contained within its
basic structure remain unchanged after chemical modification
(cross-linking with DVS).
13
The biocompatibility of Varioderm Subdermal has also been
extensively tested using the following test procedures according to
European Directive and ISO standard 10993: sensitisation, irritation,
The capsule (A) consists of a mesh-like connective tissue and includes many small
encapsulated gel particles (stained blue). On the bottom right is subcutaneous fat tissue (B). The latest development in the field
of hyaluronic acids is a highly cross-linked
Figure 3: 39 Patients Were Treated with
Different Indications
hyaluronic acid (over 70%) that has no
suspension at all and still has the best
Bitterness lines 6
injectability features.
Cheekbones 10
Cheeks
acute systemic toxicity, genetoxicity, mutagenicity and systemic
17
effect after subsutaneous implantation with three to six months of
Chin
follow-up. All results are similar to the above previous findings with
2
the DVS cross-linked hyaluronic acids, demonstrating the
Nasogenian
biocompatibility (non-inflammatory, non-toxic, non-mutagenic and
12
folds
non-genetoxic) of Varioderm Subdermal.
15
Figure 1 demonstrates
Scars
the durability in the subdermis after three months as encapsulated
2
hyaluronic acid does not migrate. In Figure 2, histological image
02468 10 12 14 16 18
at low magnification shows the capsule of the gel inclusion
consisting of a meshwork of connective tissue septa (reddish),
Number of patients
which includes many little gel zones (stained blue). Low-
The viscosity and elasticity of hyaluronic acid are affected by the inflammation cells are located in the connective tissue septa
number of bonds and rings in the molecular chains. Cross-linked around the gel zones and in the border zone towards the lumen of
hyaluronic acid has a significantly higher elasticity than non-cross- the big gel zone on the top left side. The gel was leaked from the
linked polymer with a significantly higher molecular weight.
8
big gel zone during preparation.
66 EUROPEAN DERMATOLOGY
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