Title: Dermalive
1Dermadeep Neues Konzept der Augmentation am
Anfang des 21. Jahrhunderts
?
GÄCD 2004
2AGE Control
Altern gehört zum Leben, die Frage ist nur, wie
sehr es einem schadet.
Hyaluronic Acid
Dr. med. M. E. Cornely Düsseldorf Wagnerstrasse
Dr. Harrer, Nürnberg
3Hollow cheeks with Dermadeep
Before treatment
After injection
4Soft-tissue fillers main injectable products
available on the market
gt Resorbable
gt Non-resorbable
- Collagen
- Hyaluronic acid
- Autologous fat
- Polylactic acid
- Silicone
- PMMA (collagen) Artecoll
- Acrylic Hydrogel (hyaluronic acid)
- Dermalive Dermadeep
- Poly-acrylamid
5Dermadeep
- Acrylic hydrogel (40)
- Non resorbable material
- Hyaluronic acid (60)
- Biodegradable injection vector
Suspension of flexible and non-resorbable
fragments of Acrylic Hydrogel in a sterile
non-pyrogenic and physiological solution of
slightly cross-linked Hyaluronic Acid of
non-animal origin.
6Acrylic Hydrogel
- Belongs to the Acrylate family
- Inert and elastic non-resorbable material,
renowned for its high biocompatibility - Its name "hydrogel" is derived from its high
water content (26) which is stable in the
long-term (the water molecules are trapped inside
the acrylic hydrogel molecules). - Particles are flexible, elastic and resistant
(elongation of 400 before breaking)
7Indications of Dermadeep remodelling facial
contours
- Filling very pronounced nasolabial folds
- Restoring volume to the cheeks and cheekbones
- Remodelling the chin contour
- Improving final outcome of Facelift
8Placement of Dermadeep
9Nasolabial folds with Dermadeep
Before treatment
After injection
10Clinical resultsDr. Harrer, Nürnberg
- Treated areas(2)
- Nasolabial folds 45
- Lips (contouring and perioral) 21
- Glabellar lines 13
- Cheeks and cheekbones augmentation 12
- Scars 8
- Chin folds 1
- 2 Total is gt100 as several areas may have been
treated simultaneously
11Clinical resultsDr. Harrer, Nürnberg
- Efficiency of the implant after 6 years
- ? In 96 of the cases, patients were satisfied
- with the results.
- ? 4 of the patients were dissatisfied or
- considered the results to be unsufficient.
12Clinical resultsDr. Harrer, Nürnberg
- A clinical study conducted in 1440 patients
during more than 6 years has shown the very good
tolerance and the efficiency of Dermalive
Dermadeep. - A total of 1630 syringes of Dermalive or
Dermadeep has been injected (on average 1-2
syringes per patient). - Complications only 6 out of 1440 patients
developed inflammatory granuloma
13Clinical results
- Long-term side-effects
- Since 1998, no necrosis, no immediate
hypersensitivity reaction and no case of allergy
or implant migration have been reported. -
14DERMADEEP 80-120 microns
In the INFANCY of FILLER TECHNOLOGY, SEMIPERMANENT
FILLERS HAVE BEEN ASSOCIATED WITHNUMEROUS
COMPLICATIONS eg granulomas, nodules
- microparticles larger than 40 microns have a
lower chance of being phagocytised and therefore - less likely to initiate an inflammatory reaction
when injected into the dermis and subdermis as a
filler substance
Morhenn, Lemperle and Gallo Phagocytosis of
different particulate Dermal Filler Substances by
human macrophages and skin cells. Dermatol Surg
200228484-490
15DERMADEEP
40 Hydroxyethyl methacrylate (HEMA)
microfragments 80-120 microns in size with 60
crosslinked hyaluronic acid of bacteriological
origin
WOFFLES WU MD CAMDEN MEDICAL CENTRE SINGAPORE
166 Midface Hollow Zones - Wu
Number of patients
Zone 1 - medial infraorb rim 66
Zone 2 - middle infraorb rim 125
Zone 3 - lat infraorbital rim 178
1
3
2
6
Zone 4 - Infraorbital hollow 582
4
5
Zone 5 - submalar hollow 222
Zone 6 - Malar highlight 57
Nasolabial grooves 601
Chin 129
17complications
- Complaints of visible swelling, palpable
lumpiness in - 10/683 0.00826
- 9 in NJG (8 within 1month, 1 after 2 years)
- 1 in NLG, (clinically unable to detect by
physician) - all resolved with Kanakort injections
- No redness at injections sites
- No infection
- No persistent granulomas
- No migration
18THE IDEAL FILLER
- Particulate, biocompatible material
- Chemically inert
- No migration, non liquid
- Complete encapsulation and incorporation into the
tissues - Minimal inflammation, No granuloma formation
- Easy to inject
- Long lasting NATURAL feel
19gt Dermalive
- With a five-year follow-up, a global complication
rate of less than - 2 per 1,000 (0.2) has been recorded for
Dermalive. - In most of these reported cases, this was due to
a misuse of the - product or a non-respect of the
contraindications. - Observed complications appear as nodules, oedema
and - induration at the injection site after six months
in average. - Early medical treatment in the form of
intralesional injections - (corticoids, 5FU) have been reported to be
successful.
gt Dermadeep
On 10,000 patients treated with Dermadeep, only
two side-effects have been reported to Dermatech
(4 year follow-up).
20Contraindications
- Linked to the injection site
- - Not to be injected in the Dermis
- - Not for periorbital zone, forehead wrinkles,
glabellar frown lines and lips and superficial
wrinkles - - Avoid site where another implant is already
present - - Not to be used in association with laser,
chemical peeling or dermabrasion - Linked to the individual patient
- - Tendency to develop hypertrophic scars
- - History of autoimmune disease or under
immunotherapy treatment - - Tendency to develop inflammatory and/or
infectious skin problems - - Multiple allergies
- - Known hypersensitivity to sodium hyaluronate
21Clinical Results
- Results of independent clinical studies have
confirmed the very good tolerance, the safety and
the efficiency of Dermadeep. - After 4 years of use, no necrosis, no immediate
hypersensitivity reaction - and no case of allergy or implant migration have
been reported. - However,
- the occurrence of an adverse reaction several
months or years after the injection is possible - with all implants (resorbable or non-resorbable),
- i.e. inflammatory granuloma or delayed
hypersensitivity.
22 Available since 1999, Dermadeep has been
already used successfully for treating more than
10,000 patients worldwide and has proven to be
safe and efficient for soft-tissue
augmentation. With a four-year follow-up,
only two side-effects have been reported to
us.
231. Never without clarification about the risks
2. Never transmuscular 3. Never inject
under surgery 4. Fillers only in the hands of
medical professionals
- Disinfection the area to be injected
- Dermadeep has to be slowly injected into the
epiperiostal layer or the hypodermis by using the
linear withdrawing or criss-cross technique, in
order to create a volume in the desired area by
accumulating fragments of Acrylic Hydrogel - In any case, it must not be injected into the
dermis!!!
- Do not overcorrect
- After the injection, massage the treated area for
an even distribution and a perfect integration of
the particles into the surrounding tissue - Respect a minimum 3 month period between two
injection sessions
24Hollow cheeks with Dermadeep
Before treatment
After injection