Sculptra® Cosmetic is intended for volume restoration and/or correction of moderate to deep facial wrinkles and folds such as nasolabial lines or folds.
IMPORTANT SAFETY INFORMATION
Side effects of Sculptra® Cosmetic may include injection site discomfort, redness, bruising, bleeding, or swelling. Other side effects may include small bumps under the skin that are sometimes noticeable when pressing on the treated area. Larger lumps, with or without inflammation, have also been reported. In clinical studies the numbers of bumps and lumps was low and most resolved without treatment.
Sculptra® is approved by the FDA for restoration and/or correction of the signs of facial fat loss, or lipoatrophy,
in people with human immunodeficiency virus.
In a clinical study, the effects lasted for up to 2 years after the first treatment session in most patients. The results from Sculptra® are not immediate; Sculptra® provides a gradual increase in skin thickness. Your doctor will determine the number of additional injections needed.
Sculptra® is a safe, synthetic, and biocompatible material that is injected below
the surface of the skin in the area of fat loss. It provides a gradual and significant
increase in skin thickness, improving the appearance of folds and sunken areas. No skin
testing is required.
To learn more about treatment with Sculptra®, please talk to your doctor.
Sculptra® is injected into the skin for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.
You should not use Sculptra® if you are allergic to any ingredient of Sculptra®.
Sculptra® should not be injected while you have an active skin infection or inflammation
in the treatment area.
Side effects of Sculptra® may include the delayed appearance of small bumps under the
skin in the treated area. Generally these bumps are not visible and may only be noticed when
pressing on the treated area. Other side effects may include injection-related events at
the site of injection, such as bleeding, tenderness or discomfort, redness, bruising or swelling.
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Last Update: July 2009