from the Fall 2009 issue
In late July 2009, Sculptra® Aesthetic was approved by the Food and Drug Administration (FDA) for the correction of shallow to deep nasolabial fold (smile lines), contour deficiencies and other facial wrinkles which are treated with the appropriate injection technique in healthy people. Sculptra Aesthetic is a facial volumizer that gives your face a fuller, more youthful appearance. In some people, the damage caused by the sun over time can cause sunken cheeks, hollow eyes and facial indentations. Sculptra Aesthetic is perfect for treating this condition as it stimulates your own collagen production to gradually re-volumize these areas giving you natural-looking results that can last up to 2 years.
In 2004, Sculptra was approved for use in the U.S. by the FDA for the restoration and/or correction of the signs of facial fat loss (lipotrophy) in people with human immunodeficiency virus. In Europe, Sculptra has been used since 1999 under the name New-Fill™ to treat wrinkles and contour irregularities. Dr. Suzanne Bruce is one of the original 70 U.S. physicians selected and trained in the use of Sculptra, by its maker, sanofi-aventis. In 2004, she traveled to Frankfurt, Germany to learn the technique from Dr. Gerhard Sattler, Director of the Rosenpark Klinik. Since then, she, Dr. Kristel Polder and April Harrison, PA-C, have performed hundreds of Sculptra procedures – both medically and cosmetically.
The FDA approval for Sculptra Aesthetic was on the results of a 233-patient multi-center study where patients received Sculptra Aesthetic or a human-derived collagen dermal filler for treatment of their smile lines. Sculptra Aesthetic was administered in a single treatment regimen at 3 week intervals for up to 4 treament sessions for correction of shallow to deep nasolabial fold contour deficiencies using a specific deep dermal injection technique. Sculptra Aesthetic patients were followed for an additional 12 months, and the Sculptra Aesthetic treatment effects were maintained up to 25 months after the last treatment session. The human-derived collagen dermal filler was effective only up to 3 months.
Sculptra™ is a synthetic, injectable material known as poly-L-lactic acid, a bio compatible, biodegradable material widely used for many years in dissolvable sutures. It is injected below the surface of the skin in the area of fat loss. The injected material stimulates the body to produce new collagen, which results in a gradual increase in skin thickness. More than one treatment session spaced several weeks apart may be required to achieve the desired results.
Because it causes the body to produce its own collagen, Sculptra Aesthetic can last two years. Touch-up treatments may be needed to maintain the desired effect. The most common side effects with the use of Sculptra are injection-related issues at the site of the treatment, such as tenderness or pain, redness, bruising or swelling. These side effects generally resolve in a few days.
One possible delayed side effect with Sculptra Aesthetic can be small bumps under the skin in the treated area. These small bumps are not usually visible, and you may notice them only when you press on the treated skin. These bumps tend to happen within the first six-to-twelve months after the first treatment. Our experience has shown that careful, experienced injection can generally avoid these small lumps and bumps, which are usually not visible. We are in our 6th year of injecting Sculptra and now Sculptra Aesthetic, and our patients have been very pleased with the natural-looking results.
If you would like to schedule a free consultation with Dr. Kristel Polder or April Harrison, PA-C, to see if Sculptra Aesthetic is the right facial-rejuvenating treatment for you, please call 713.850.0240 and press 2.
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