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 Defyne
PMA Applicant: Q-Med AB
Address: Galderma Laboratories, L.P.
14501 North Freeway
Fort Worth, TX 76177
Approval Date: 01/29/2021
Approval Letter: Approval Order
What is it?
Restylane Defyne is a gel implant (dermal filler) injected into specific areas of facial tissue. It consists of crosslinked hyaluronic acid made by a species of bacteria and formulated to a concentration of 20 mg/mL with 3 mg/mL of the drug lidocaine hydrochloride as a numbing agent.
This product was previously approved for injection into facial tissue to improve the appearance of smile or laugh lines (nasolabial folds) in patients over the age of 21. This approval expands the use of this product to include the chin region.
How does it work?
A doctor (dermatologist or plastic surgeon) injects Restylane Defyne gel into the chin area to temporarily add volume and fullness.
When is it used?
Restylane Defyne is indicated for injection into the chin region to improve the chin profile appearance in patients over the age of 21.
What will it accomplish?
In a clinical study, 12 weeks following treatment, Restylane Defyne was found to improve the chin profile appearance in 86.1% of patients. Effects were observed as long as 48 weeks after treatment in 73.7% of patients.
Common side effects include:
- Lump/Bump formation
When should it not be used?
Restylane Defyne should not be used in patients with history of:
- Severe allergies that lead to anaphylaxis
- Multiple severe allergies
- Allergies to gram-positive bacterial proteins
- Allergies to lidocaine
Additional information (including warnings, precautions, and adverse events):
- Summary of Safety and Effectiveness Data (SSED)
- Patient Labeling
- Physician Labeling
- PMA Database Entry