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: Perlane® Injectable Gel
PMA Applicant: Medicis Aesthetics Holdings Inc.
Address: 8125 North Hayden Road, Scottsdale, Arizona 85258
Approval Date: May 2, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040024S006a.pdf
What is it? Perlane® is composed of transparent, viscous gel particles of hyaluronic acid that are implanted into facial tissue to provide volume in or just under the skin to smooth wrinkles and folds, especially around the nose, mouth and under the edges of the mouth (nasolabial folds and oral commissures). Hyaluronic acid is a protective, lubricating and water-binding substance that is produced naturally by the body.
How does it work? Perlane® works by temporarily adding volume to facial tissue and restoring a smoother appearance to the face
When is it used? Perlane® is injected by a doctor into areas of facial tissue where moderate to severe facial wrinkles and folds occur as a result of loss of underlying volume. The gel particles temporarily add volume in and under the skin to restore surface contour and give the skin a smoother and more youthful appearance.
What will it accomplish? Perlane® will help smooth moderate to severe facial wrinkles and folds. In two clinical studies, 89% of the Perlane patients achieved optimal correction of midface volume loss that caused their wrinkles and fold (nasolabial folds and oral commissures). The surface contour improvement lasted for at least 6 months.
Immediate side effects of Perlane® include:
When should it not be used? Perlane is contraindicated for the following:
- Patients with severe allergies (manifested by a history of anaphylaxis or the history or presence of multiple severe allergies).
- Patients with a history of allergies to gram positive bacterial proteins.
- Patients with bleeding disorders.
Additional information: The Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p040024s006