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Important Safety Information
(injectable poly-L-lactic acid)
is indicated for use in people with healthy
immune systems as a single regimen for the correction of shallow to deep
nasolabial fold contour deficiencies and other facial wrinkles in which
deep dermal grid pattern (cross-hatch) injection technique is appropriate.
Sculptra Aesthetic should not be used by people that are allergic to any
ingredient of the product or have a history of keloid formation or
hypertrophic scarring. Safety has not been established in patients who are
pregnant, lactating, breastfeeding, or under 18 years of age.
Sculptra Aesthetic has unique injection requirements and should only be
used by a trained physician. Contour deficiencies should not be
overcorrected because they are expected to gradually improve after
Sculptra Aesthetic should not be injected into the blood vessels as it may
cause vascular occlusion, infarction or embolic phenomena. Use at the site
of skin sores, cysts, pimples, rashes, hives or infection should be
postponed until healing is complete. Sculptra Aesthetic should not be
injected into the red area (vermillion) of the lip or in the peri-orbital
The most common side effects after initial treatment include injection site
swelling, tenderness, redness, pain, bruising, bleeding, itching and lumps.
Other side effects may include small lumps under the skin that are
sometimes noticeable when pressing on the treated area. Larger lumps, some
with delayed onset with or without inflammation or skin discoloration, have
also been reported.
Sculptra Aesthetic is available only through a licensed practitioner. View
the complete Instructions for Use.
Indication: Sculptra® Aesthetic (injectable poly-L-lactic acid) is indicated for use in people with healthy immune systems as a single regimen for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate.