DESCRIPTION: Until now, there were no products approved by the FDA to treat facial lipoatrophy. However, that is all changing with the introduction of Sculptra™ in the United States, offering an effective option to treat the effects of lipoatrophy. Sculptra™ (poly-L-lactic acid) has been safely used outside the United States since 1999 in over 150,000 patients under the trade name New-Fill™.
Facial fat loss, or lipoatrophy, is the loss of fat beneath the skin, which can result in sunken cheeks, indentations, and hollow eyes. 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.
TREATMENT TIME & RESULTS: After the first treatment, it may appear that Sculptra™ worked immediately. Typically, patients will experience some degree of edema associated with the injection procedure, which will give the appearance of a full correction by the end of the injection session (within about 30 minutes). The patient should be informed that the injection-related edema typically resolves in several hours to a few days, resulting in the "reappearance" of the original contour deficiency. Sculptra™ takes time to gradually correct the depression in the skin.
Each patient should be evaluated individually. More than one treatment session may be required. Patients with severe facial fat loss may require 3 to 6 treatment sessions.
Treatment effects will differ for each person. In a clinical study, the treatment results lasted for up to 2 years after the first treatment session, in most patients. Touch-up treatments may be needed to maintain the desired effect.
AFTER CARE: Most patients feel comfortable going back to their normal activities following treatment. Make-up may be applied a few hours after treatment if no complications are present (e.g., open wounds or bleeding).
The most commonly observed product-related adverse event has been the delayed occurrence of subcutaneous papules (5 mm or less), which were typically palpable, asymptomatic, non-visible, and confined to the injection site area. Other reported side effects of Sculptra™ include immediate and transient injection-related events such as bleeding from the injection site, discomfort, erythema or inflammation, ecchymosis, and edema. Patients should be advised to report any side effects to their health care provider.