Important Safety Information
Indication: Restylane® Silk is indicated for
submucosal implantation for lip augmentation
and dermal implantation for correction of
perioral rhytids in patients over the age of 21.
Restylane Silk contains traces of gram-positive
bacterial protein and is contraindicated for
patients with allergies to such material or
for patients with severe allergies that have
required in-hospital treatment. Restylane Silk
should not be used by patients with bleeding
disorders, with hypersensitivity to amide-type
local anesthetics, such as lidocaine, under
the age of 22, or by women who are pregnant
or breastfeeding. Restylane Silk should not
be injected anywhere except the dermis or
lip submucosa.
Use of Restylane Silk at the site of skin sores,
pimples, rashes, hives, cysts, or infection
should be postponed until healing is complete.
The most commonly observed side effects
are swelling, tenderness, bruising, pain, and
redness at the injection site. These are typically
mild in severity and resolve in 2-7 days after
treatment. Serious but rare side effects include
delayed onset infections, recurrence of herpetic
eruptions, and superfi cial necrosis and scarring
at the injection site. Do not implant into blood
vessels. Use with caution in patients recently
treated with anticoagulant or platelet inhibitors
to avoid bleeding and bruising.
Treatment volume should be limited to 1.5 mL
per lip per treatment and 1.0 mL for perioral
rhytid correction, as greater amounts signifi cantly
increase moderate and severe injection site
reactions. The safety or effectiveness of treatment
in areas other than lips and perioral rhytids
has not been established in controlled
clinical studies.
Restylane Silk is only available through a
licensed practitioner. Complete Instructions for
Use are available at www.RestylaneSilk.com.
Restylane and Galderma are registered trademarks of Galderma S.A.
© 2015 Galderma Laboratories, L.P.
SLK-064A 02/15