The FDA’s Center for Devices and Radiological Health has posted online information for three recently approved aesthetic products. The following is information provided to consumers on the FDA Web site, www.fda.gov.
• Radiesse is an injectable calcium hydroxyapatite implant in the form of a gel. It works by temporarily adding volume to facial tissue and restoring a smoother appearance to the face.
Radiesse is intended for restoration or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. It is injected by a physician into areas of facial tissue where moderate to severe wrinkles and folds occur. The smoothing effect lasts up to 6 months.
Side effects of Radiesse include bruising, redness, swelling, pain, tenderness, and itching. Radiesse should not be used in patients who are hypersensitive to any of the components of the product, have severe allergies manifested by a history of anaphylaxis, or history or have multiple severe allergies.
• ArteFill is a filler injected into the nasolabial folds around the mouth to smooth wrinkles. It contains small poly(methyl methacrylate) beads, collagen, and lidocaine. ArteFill is injected by a physician into the facial tissue around the mouth.
In a clinical study, most patients needed more than one injection to achieve optimal wrinkle smoothing. The average number of treatment sessions was 2.28.
Side effects of ArteFill include lumpiness at injection area more than 1 month after injection, persistent swelling or redness, increased sensitivity, and rash and itching more than 48 hours after injection.
ArteFill should not be used in patients who have a positive response to the ArteFill skin test, severe allergies with a history of anaphylaxis or presence of multiple severe allergies, allergies to bovine collagen or lidocaine, or susceptibility to form keloid or hypertrophic scars. It should not be used for implantation into blood vessels because it may obstruct blood flow and lip augmentation or injection into the vermilion or the wet mucosa of the lip.
• Cosmetic Tissue Augmentation Product (CTA) is a transparent hyaluronic acid gel with 0.3% lidocaine that is injected into facial tissue to smooth wrinkles and folds, around the nose and mouth. Hyaluronic acid is a protective, lubricating, and binding gel that is produced naturally by the body. CTA works by temporarily adding volume to facial tissue and restoring a smoother appearance to the face. The effect lasts for about 6 months.
In a clinical study, most patients needed one injection to achieve optimal wrinkle smoothing. About one fourth of the patients needed more than one injection to get a satisfactory result.
Side effects of CTA include bruising, redness, swelling, pain, and tenderness. CTA should not be used in patients who have severe allergies marked by a history of anaphylaxis or severe allergies to gram-positive bacterial proteins or lidocaine. It should not be used for implantation into bone, tendon, ligament, or muscle or implantation into blood vessels, because it may obstruct blood flow.
[FDA, January 29, 2007]