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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Cosmetic Tissue Augmentation Product
PMA Applicant: Anika Therapeutics, Inc.
Address: 236 West Cummings Park Woburn, MA
Approval Date: December 20, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050033a.pdf
What is it? 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, especially around the nose and mouth (nasolabial folds). Hyaluronic acid is a protective, lubricating and binding gel substance that is produced naturally by the body.
How does it work? CTA works by temporarily adding volume to facial tissue and restoring a smoother appearance to the face. The effect lasts for about 6 months.
When is it used? CTA is injected by a doctor into areas of facial tissue where moderate to severe facial wrinkles and folds occur. The gel temporarily adds volume to the skin and can give the appearance of a smoother surface.
What will it accomplish? CTA will help smooth moderate to severe facial wrinkles and folds. In a clinical study most patients needed one injection to achieve optimal wrinkle smoothing; about one-quarter of the patients needed more than one injection to get a satisfactory result. The smoothing effect lasted about six months.
Side effects of CTA include:
When should it not be used? CTA should not be used in patients who have:
- severe allergies marked by a history of anaphylaxis ( hypersensitivity to the ingestion or injection of a drug or protein)
- severe allergies to gram-positive bacterial proteins or lidocaine
CTA should not be used for:
- implantation into bone, tendon, ligament, or muscle
- implantation into blood vessels, because it may obstruct blood flow
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050033