The FDA has approved Sanofi-aventis US’ anti-wrinkle product SculptraAesthetic for the correction of shallow to deep nasolabial fold, also called smile lines, contour deficiencies and other facial wrinkles with the appropriate injection technique in healthy patients. SculptraAesthetic works gradually to offer natural-looking results that can last up to two years.

The FDA has approved the use of Sculptra Aesthetic long acting facial filler that builds collagen. Sculptra Aesthetic (injectable poly-L-lactic acid) has been approved for use by a trained physician to correct shallow to deep nasolabial fold (smile lines) contour deficiencies and other facial wrinkles. The injectable dermal filler works gradually to offer natural-looking results that can last up to two years. The treatment was available in Europe for a decade.

The Physicians Coalition for Injectable Safety has issued a warning against the growing popularity of cosmetic injectables being offered as prizes or gifts. The Coalition leader, Renato Saltz, MD, of Salt Lake City, Utah, says that these injectables are medical treatments and should be taken only if prescribed by a physician.

In late January, a consumer group called Public Citizen filed a petition with the FDA requesting labeling alterations for botulinum toxins (Botox(R)) or Myobloc(R)) marketed in the U.S. The American Society for Aesthetic Plastic Surgery (ASAPS), which is the sole plastic surgery organization devoted completely to the advancement of cosmetic surgery, said that “the safety references in the petition are already satisfactorily addressed in the manufacturer labeling with detailed information and guidance, including approved indications, contraindications, warnings, drug interactions, precautions, and reported adverse event information.”

The ASAPS added that the product is “safe and efficacious,” while recommending its continued use as indicated.