RestylaneŽ
Restylane® is a safe and natural cosmetic
dermal filler that restores volume and fullness
to the skin to correct facial wrinkles and folds,
such as nasolabial folds.
Restylane is a cosmetic dermal filler made of
hyaluronic acid, a natural substance that already
exists in the human body. The hyaluronic acid in
Restylane is a crystal-clear gel called NASHA™
or Non-Animal Stabilized Hyaluronic Acid. NASHA
is completely biocompatible with human hyaluronic
acid.
Restylane maintains its shape using the body's
own moisture. The hyaluronic acid in Restylane
is hydrophilic or "water loving." As
hyaluronic acid gradually degrades, each molecule
binds to more water and over time, the same volume
can be maintained with less hyaluronic acid. This
ability of hyaluronic acid to bind to water is
what helps provide lasting results.
Unlike rooster-derived hyaluronic acids and bovine
collagen products, Restylane is free from animal
proteins. This limits any risk of animal-based
disease transmissions or development of allergic
reactions to animal proteins.
What can I expect?
You should take a few precautions before being
treated with Restylane®. One week prior to
treatment with Restylane, avoid taking St. John's
Wort, high doses of Vitamin E supplements, aspirin,
and other non-steroidal anti-inflammatory medications,
such as ibuprofen. These agents may increase bruising
and bleeding at the injection site. Also, if you
have previously suffered from facial cold sores,
there is a risk that the needle punctures could
contribute to another recurrence.
Restylane is injected directly into the skin
in tiny amounts by an ultrafine needle, resulting
in minimal discomfort. The procedure is simple
and convenient and results are practically instantaneous.
To optimize your comfort during the short procedure,
your physician may decide to numb the treatment
area
Is Resylane safe ?
Since 1996, over 3 million Restylane® treatments7
have been safely administered by dermatologists
and plastic surgeons in more than 70 countries.
This innovative treatment is now approved in the
U.S. for the treatment of facial wrinkles and
folds.
Restylane has a highly favorable safety profile.
It's composed of Non-Animal Stabilized hyaluronic
acid. Hyaluronic acid is a substance found naturally
in the human body. Restylane is fully biocompatible.
There is limited risk of animal-based disease
transmission or development of allergic reactions
to animal proteins. No allergy testing is required
before use.*
Based on clinical studies3, Restylane treatments
produce a low occurrence of adverse events. The
most commonly reported side effects were temporary
redness and swelling at the injection site. These
effects typically resolve in less than seven days.
Precautions
• The safety of Restylane for use during
pregnancy, in breastfeeding females or in patients
under 18 years has not been established.
• The safety of Restylane in patients with
increased susceptibility to keloid formation and
hypertrophic scarring has not been studied. Restylane
should not be used in patients with known susceptibility
to keloid formation or hypertrophic scarring.
• The patient should be informed that he
or she should minimize exposure of the treated
area to excessive sun and UV lamp exposure and
extreme cold weather until any initial swelling
and redness has resolved.
• If laser treatment, chemical peeling or
any other procedure based on active dermal response
is considered after treatment with Restylane there
is a possible risk of eliciting an inflammatory
reaction at the implant site. This also applies
if Restylane is administered before the skin has
healed completely after such a procedure
What are my post-treatment instructions?
Your healthcare professional should discuss what
to do after your treatment. However, be sure to
review the information below and discuss any concerns
with them.
Post-Treatment Checklist
Please observe the following after treatment
with Restylane®.
• After your treatment, you might have
some redness or swelling. This will normally last
less than seven days. Sunbathing and cold outdoor
activities should be avoided until any redness
or swelling disappear. If you are pregnant, breastfeeding,
or under 18, you shouldn't use Restylane.
• Avoid touching the treated area within
six hours following treatment. After that, the
area can be gently washed.
• Sunbathing and cold outdoor activities
should be avoided until any redness or swelling
disappear.
• If you have previously suffered from
facial cold sores, there is a risk that the needle
punctures could contribute to another recurrence.
Speak to your physician about medications that
may minimize a recurrence.
• Avoid exercise and alcohol for six hours
after your treatment.
• Having a follow-up treatment before
the product has fully dissipated may enhance the
lasting effect. Please be sure to consult your
physician about recommendations for touch-up or
follow-up treatments.
• One week prior to your next treatment
with Restylane, avoid taking St. John's Wort,
high doses of Vitamin E supplements, aspirin,
and other non-steroidal anti-inflammatory medications,
such as ibuprofen. These agents may increase bruising
and bleeding at the injection site
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