Sculptra Aesthetic - P030050/S002
This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Sculptra Aesthetic
Applicant:Sanofi-Aventis U.S. LLC
Address: 9 Great Valley Parkway Malvern, PA 19355
Approval Date: July 28, 2009
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030050S002a.pdf
What is it? Sculptra Aesthetic is an implant of poly-L-lactic acid (PLLA) microparticles. It is injected into the facial tissue to correct shallow to deep smile lines (nasolabial fold) contour deficiencies and other facial wrinkles.
How does it work? Sculptra Aesthetic works by initially filling a wrinkle with small PLLA beads. As the beads break down, the body may produce collagen where Sculptra Aesthetic is injected.
When is it used? Sculptra Aesthetic is injected by a doctor in persons with healthy immune systems as a one-time treatment regimen of up to 4 injection sessions that are scheduled about 3 weeks apart when a deep dermal grid pattern (cross-hatch) injection technique is appropriate.
What will it accomplish? Sculptra Aesthetic helps to correct and smooth shallow to deep nasolabial fold contour deficiencies and other facial wrinkles. In a clinical study, patients were injected in a single regimen of up to 4 sessions (at 3 week intervals) over a 9 week period of time. The smoothing effect lasted for up to 25 months in some patients depending upon the initial severity of the facial wrinkle and fold contour deficiency.
- Short-term reactions such as:
- Localized swelling
- Localized tenderness
- Localized redness
- Post-injection site pain/discomfort
- Localized bruising
- Bleeding from site(s)
- Localized itching
- Delayed reactions include:
- Small bumps and lumps
When should it not be used? Sculptra Aesthetic should not be used in patients who:
- are allergic to any components of Sculptra Aesthetic.
- have a known history of or are susceptible to scarring which is unusually massive, colored or may itch or be generally painful.
- have a skin infection or inflammation in the treatment area.
Sculptra Aesthetic should not be injected into the red area of the lip or in the skin near the eyes.
Additional information: The Summary of Safety and Effectiveness and Labeling are available online.