Restylane filler presentation

1. Restylane
“The Filler of the New Millennium”
Physician Name, MD

2. Introduction
“How Happy are You with Your Appearance”?
-Consumer Poll in March 2003
• Nearly half gave a score of 5 or less on a scale of
10
• Only 1 in 4 adults Americans consider themselves
attractive
• 30% indicate they would change something about
their looks

3. Epidemic of Aging
• Increasing percentage of US population
aged 45 years or greater.
• Population over 45 will increase 20% from
2000-2025
• 59.2 million people in America between the
ages of 45-59
• Aging Baby Boomers will have substantial
impact on aesthetic marketplace

4. Facial Aging
• Thinning of the dermis and atrophy of fat pads
• Loss of elasticity
• Greater visibility of bony landmarks, blood
vessels, wrinkles and furrows
• Transverse forehead lines
• Lowering of the eyebrows
• Descent of the corners of the mouth
• Ptosis of nasal tip

5. Aging in the Lower Face
• Increase prominence of the nasolabial folds
• Deepening of the nasolabial groove
• Ptosis of commissure
• Thinning of the lips
• Flattening and lengthening of the upper lip
• Lateral mandibular groove
• Prejowl depression
• Less defined cupids bow
• Perioral rhytids

6. The 4 “R”s of Facial Aesthetics
• Resurface
• Relax
• Refill
• Redrape

7. Recontouring with Fillers
Fillers provide patient with fuller, youthful face and
can soften the appearance of aging
• Permanent • Non-Permanent
-Lasting over 12 months – Lasting under 12
-Non-degradable months
-Remains in the tissues – Degradable
-Appearance can become – Temporary in case
distorted due to aging patient is not satisfied
process
– Side-effects usually
-Long-term side effects:
mild and transient
Granulomas, asymmetry,
lumpiness, migration – Animal vs. Non-animal
-Must be removed if effect
is undesirable

8. Permanent Fillers May Cause
Permanent Problems
Think twice before you ask your doctor for a
permanent solution:
“Forever is a long, long time”

9. Science of Hyaluronic Acids

10. History of Hyaluronic Acid
• 1934: Meyer and Palmer first isolated hyaluronic
acid from bovine vitreous humor
• 1970s: First used therapeutically in human
medicine and surgery
• First product containing HA (for use in eye
surgery) and (treatment of osteoarthritis)
• 1980s: Biomatrix, Inc. developed second-
generation hyaluronic acid derivatives (hylans)
through cross-linking (stabilization), greatly
increasing tissue residency

11. Hyaluronic Acid
• Has a simple chemical structure and is
identical in all species and tissues; thus is
non-immunogenic
• Found in all vertebrates and synthesized by
some bacteria
• Ideal biomaterial substance of use as a filler
• Highly hydrophilic – “Loves water”
• Rapidly metabolized in the body

12. Stabilization of HA
• Unmodified HA has a half-life in the body of
24-48 hrs
• Stabilization increases the length of time it
exists in the skin.
• Modification should be minimal so that the
body sees the material as native.
• HA must be cross-linked to stabilize the
molecule

13. Physiologic Functions of HA
• Important component of the extracellular space
• Maintains proper structure and tissue function by:
– Creating volume through high water binding capability
– Protecting and lubricating tissues, joints and tendons
– Affecting cell integrity, mobility and proliferation
– Filtration and regulation of protein distribution
– Transportation of nutrients to and from cells
• Importance of HA in the skin:
– Maintains volume and viscoelasticity
– HA concentrations decrease with age1
1. Longas MO et al. Carbohydr Res. 1987;159:127-136.

14. Concentration/Distribution of HA
. • Average concentration of HA in
human body: 200mg/kg
• Largest distribution of HA is in
skin: 56%
8%
1%
8%
Skin
Connective Tissue
Muscle
56% Intestines
27% Other
Distribution of HA

15. Differences between Animal and Non-
Animal Based HA Products
• Source and Purity:
– NASHA™ products (from bacteria) are more pure than animal-
based HA products (from chicken combs)
– Animal based products may require skin testing
• Stabilization:
– NASHA™ product modified 1%
– Hylaform® products modified 20%
• Biocompatibility:
– Due to lower degree of cross-linking, NASHA™ products are
more biocompatible than Hylaform® products
– Increased biocompatibility indicates longer tissue residency

16. Non-Animal Based HA Products
• NASHA™ - Patented form of non-animal based HA
– Source: Bacteria (streptococcus) fermentation process
– Purity: Minimal and well-defined impurities
– Stabilization: Achieved by adding small amount of
organic solvent
• Degree of cross-linking is 1%
• Product remains biocompatible
– Concentration: 20mg/mL of HA for all products
– Degradation: Maintains initial volume through process of
isovolemic degradation
• Bead contains 5x more HA than needed for volume maintenance
• As stabilization bridges (or cross-links) disappear, water bonds in
its place
• More volume is maintained with less product

17. NASHA-based on three considerations
• To provide pure hyaluronic acid
• To stabilize the molecule by the minimum
possible modification-for longer duration
and minimal tissue disturbance
• High clinical performance as well as safe
use with minimal side effects. The
hyaluronic acid is virtually unchanged and
therefore similar to native hyaluronic acid

18. Isovolemic degradation
• The NASHA-gel is slowly degraded over
time
• Isovolemic degradation. The initial volume
of the material is maintained throughout the
degradation phase
• The less concentrated the gel becomes – the
more water each molecule is able to bind

19. Isovolemic degradation

20. Restylane
“ The Filler of the New Millennium”
• Biocompatible • Stable after injection
• Non-antigenic • Non-migratory
• Non-pyrogenic • Long-lasting but
• Non-inflammatory resorbable
• Non-toxic • Natural looking
• Non-animal • Forgiving
• Not too expensive

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