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Poly-L-lactic acid: Poly-L-lactic acid is a biodegradable, biocompatible man-made polymer. This material has wide
uses in absorbable stitches and bone screws. Poly-L-lactic acid is a long lasting filler material that is given in a series
of injections over a period of several months. The effects of Poly-L-lactic acid generally become increasingly apparent
over time (over a period of several weeks) and its effects may last up to 2 years.
SCULPTRA® Aesthetic (injectable poly-L-lactic acid)
SCULPTRA ®Aesthetic is an injectable implant containing microparticles of poly-L-lactic acid (PLLA),
carboxymethylcellulose (USP), non-pyrogenic mannitol (USP) and sterile water for injection (USP). SCULPTRAAesthetic
is available in 367.5 mg dose vials and is to be reconstituted prior to use by the addition of 5 mL of Sterile Water for
Injection, USP (SWFI) to form a sterile nonpyrogenic suspension. SCULPTRA Aesthetic is indicated for use in
immune-competent people as a single regimen for 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 is injected into the facial tissue to correct shallow to deep smile lines (nasolabial fold) contour
deficiencies and other facial wrinkles. Sculptra Aesthetic works by initially filling a wrinkle with small PLLA beads. As the
beads break down, the body may produce collagen where Sculptra Aesthetic is injected. Sculptra Aesthetic is injected by
a doctor in persons with healthy immune systems as a one-time treatment regimen of up to 4 injection sessions that are
scheduled about 3 weeks apart when a deep dermal grid pattern (cross-hatch) injection technique is appropriate.
Sculptra Aesthetic helps to correct and smooth shallow to deep nasolabial fold contour deficiencies and other facial
wrinkles. In a clinical study, patients were injected in a single regimen of up to 4 sessions (at 3 week intervals) over a 9
week period of time. The smoothing effect lasted for up to 25 months in some patients depending upon the initial severity
of the facial wrinkle and fold contour deficiency.
Side-effects include localized swelling, localized tenderness, localized redness, post-injection site pain/discomfort,
localized bruising, bleeding from site(s), localized itching, delayed reactions such as small bumps and lumps. Sculptra
Aesthetic should not be used in patients who are allergic to any components of Sculptra Aesthetic, and those have a
known history of or are susceptible to scarring which is unusually massive, colored or may itch or be generally painful.
The Food and Drug Administration, on August 3, 2004, approved Sculptra, an injectable filler to correct facial fat loss in
people with human immunodeficiency virus (HIV). Sculptra is the first such treatment approved for a condition known as
lipoatrophy, or facial wasting, a sinking of the cheek, eye and temple areas of the face caused by the loss of fat tissue
under the skin which can affect HIV patients. FDA expedited review of the product because of its importance in treating
people living with AIDS.
The Food and Drug Administration (FDA) on August 3, 2004 also approved an injectable filler to correct facial fat loss in
people with human immunodeficiency virus (HIV) infection.