The U.S. Food & Drug Administration (FDA) approved Sculptra (injectable poly-L-lactic acid) for the restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus (HIV). Facial lipoatrophy is the loss of fat beneath the skin, which can result in sunken cheeks, indentations, and hollow eyes. Lipoatrophy is common among HIV patients.

Sculptra is a synthetic and biocompatible material that is injected below the surface of the skin in the area of fat loss. Sculptra contains microparticle beads of poly-L-lactic acid, a biocompatible, biodegradable, synthetic polymer from the alpha-hydroxy-acid family. Sculptra provides a gradual and significant increase in skin thickness, improving the appearance of folds and sunken areas.

Visible results appear in the first few treatment sessions. Typically, 3 to 6 sessions are conducted and additional touch-up treatment may be needed. Over time, the beads break down and may be replaced with natural collagen. For most people who participated in a clinical study, the treatment results lasted for up to two years after the first treatment session. Assessments will be done 2 weeks or more after treatment to determine if additional injections are required.

Sculptra should not be used by those who are allergic to any ingredient of Sculptra. Sculptra should not be injected while there is an infection or inflammation in the treatment area.

Sculptra should not be used by those who are allergic to any ingredient of Sculptra, including poly-L-lactic acid, carboxymethylcellulose, and nonpyrogenic mannitol.

Sculptra should not be injected while there is an infection or inflammation in the treatment area. Sculptra should not be used if a patient has had or has risks for hypertrophic scarring or keloid formation. Tell your provider if you have an active skin infection or inflammation (i.e., cysts, pimples, rash or hives), or problems with hearing located close to the treatment site.

Patients who have coagulation defects or are using blood thinners or anticoagulants such as aspirin, warfarin, or Plavix may be at a greater risk of hematoma formation, bleeding or bruising at the injection site. NSAIDs may also increase the risk for bleeding/bruising.

Skin testing is not required prior to using Sculptra.

Studies of Sculptra for longer than 2 years has not been done. Also, safety and effectiveness in pregnancy or breast-feeding has not been done. Use of Sculptra in patients less than 18 years of age is not recommended.

Studies of the use of Sculptra with lidocaine for local anesthesia, or with other drugs or implants has not been completed. However, your healthcare provider may recommend the use of lidocaine for anesthesia.

There have been reports of an increased risk of papules and nodules after injecting Sculptra around the eye (periorbital) area.

After Sculptra treatment, avoid sun and UV lamp exposure until initial redness and swelling has subsided.

Chemical peels, laser treatment, or any other active dermal treatment given before or after Sculptra treatment may result in an increased inflammatory response at the Sculptra implant site, especially if the area of active dermal treatment has not healed.

Sculptra should not be injected into the red area of the eyes or of the lips.

If facial radiologic imaging, such as computed tomography (CT) scan or magnetic resonance imaging (MRI), is to take place, notify your physician in advance that you have had Sculptra treatments.