Restylane® Contour – P140029/S032
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: Restylane Contour
PMA Applicant: Q-Med AB
Address: Galderma Research & Development, LLC, 14501 North Freeway, Fort Worth, TX 76177
Approval Date: June 28, 2021
Approval Letter: Approval Order
What is it?
Restylane Contour is a gel implant (dermal filler) injected into specific areas of facial tissue. It consists of crosslinked hyaluronic acid made by a species of Streptococcal bacteria and formulated to a concentration of 20 mg/mL with 3 mg/mL of the drug lidocaine hydrochloride as a numbing agent.
How does it work?
A doctor (dermatologist or plastic surgeon) injects Restylane Contour into the cheeks or midface to temporarily add volume and fullness.
When is it used?
Restylane Contour is indicated for use in cheek augmentation and correction of shape or volume differences in the midface region (contour deficiencies) in people over the age of 21.
What will it accomplish?
Restylane Contour may help improve the midface fullness by temporarily adding volume. In a clinical study, Restylane Contour performed as well as an approved dermal filler for cheek augmentation. Ninety-one percent (125/137) of patients saw improvement in midface fullness 12 weeks after injection. The results may last up to 48 weeks.
When should it not be used?
- Restylane Contour should not be used in patients with history of:
- Severe allergies that lead to whole-body allergic reaction or anaphylaxis
- Multiple severe allergies
- Allergies to gram-positive bacterial proteins
- Allergies to lidocaine