Sculptra - Liquid Face Lift Association

Sculptra^® Aesthetic is a biocompatible, biodegradable dermal filler indicated for the treatment of facial lines and wrinkles. Sculptra^® is also indicated for treatment of the loss of fat beneath the skin that sometimes causes sunken cheeks, indentations and hollow eyes (facial lipoatrophy). Lipoatrophy is the loss of fat beneath the skin that leads to facial thinning, sunken cheeks, deep lines, prominent skin folds, and a gaunt appearance. Sculptra^® contains micro-particles of poly-L-lactic acid, a substance that has been safely used for more than 20 years in surgical products such as dissolvable sutures. Sculptra^® is suitable for a wide variety of reconstructive and cosmetic uses.

Sculptra^® has been used for many years internationally under the brand name New-Fill and was approved in Europe in 1999 for the correction of skin depressions such as nasolabial folds. Subsequently, the indication was expanded to include treatment of lipoatrophy. In the United States, Sculptra^® was approved by the Food and Drug Administration (FDA) in 2004 for the treatment of HIV-related lipoatrophy. In 2009, the FDA approved Sculptra^® Aesthetic for use in treating facial wrinkles.

Sculptra^® appears to work by stimulating a local immune response that leads to a very gradual absorption of the poly-l-lactic acid microparticles by white blood cells. This immune response to Sculptra^® also leads to production of fibrosis and collagen deposition under the skin. This combination of fibrosis and collagen production is believed to be the reason for the gradual increase in skin thickness and the longer durability of response to Sculptra^® compared with many other facial fillers.

Sculptra^® is considered by many to be a tissue volumizer, helping fill concave facial areas and improving facial contours. For instance, Sculptra^® may be effective in providing contour to flattened temple areas or sunken areas below the cheek pads.

Sculptra^® is typically administered in a series of treatments separated by 4 to 6 weeks in order to achieve optimal results. Depending on

the degree of facial atrophy, facial contouring or wrinkle correction goals, it may be necessary to perform between 2 to 6 sessions.

The contour improvement is usually reached after a few months and may last up to 2 years or more. Some of the factors that likely affect the durability of response include physician technique and experience, patient age, skin thickness and quality, and the degree of movement of underlying facial muscles. For sustained results, it is likely that periodic touch up treatments will be necessary on an as needed basis.

Most commonly reported side effects may include temporary injection-related events at the site of injection, such as tenderness or discomfort, redness, bruising, or swelling. Sculptra^® injections may also occasionally produce small bumps or nodules under the skin in the treated area. Generally these nodules are not visible and may only be noticed when pressing on the treated area. The chance of this complication may be minimized by thorough massage of the treated area immediately after the injection and then two to three times daily for one week following treatment. Consult your physician for a complete list of potential side effects.

Sculptra^® is a registered trademark of Dermik Laboratories, a business of sanofi-aventis U.S. LLC

Contributing Physicians:

William Heimer II MD & Melanie Palm MD, Encinitas, CA ~ Gerald Pierone Jr. M.D., Vero Beach, FL
Stuart B. Kincaid MD FACS, Temecula, CA ~ Victor G. Lacombe M.D., Santa Rosa, CA
Richard G. Asarch M.D., Englewood, CO ~ William Heimer II M.D., San Diego, CA
Allison Stocker M.D., San Antonio, TX ~ Christine A. Hamori MD, Nantucket, MA
Maurice P. Sherman M.D., Del Mar, CA ~ Jeffry B. Schafer M.D., Coronado, CA
Joel Shanklin MD FACS, Savannah, GA ~ Hayley DeGraaff MD, Huntsville, AL