Restylane® Kysse - P140029/S021
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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Restylane® Kysse
PMA Applicant: Q-Med, AB
Address: Galderma Laboratories, L.P.
14501 North Freeway
Fort Worth, TX 76177
Approval Date: March 26, 2020
Approval Letter: Approval Order
What is it?
Restylane® Kysse 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.
How does it work?
A doctor (dermatologist or plastic surgeon) injects Restylane® Kysse gel into the lips or the wrinkles located above the lips (upper perioral rhytids) to temporarily add volume and fullness.
When is it used?
Restylane® Kysse is indicated for injection into the lips for lip augmentation and the correction of wrinkes above the lips (upper perioral rhytids) in patients over the age of 21.
What will it accomplish?
A multi-center, randomized, evaluator-blinded, study was conducted to evaluate the effectiveness and safety of Restylane® Kysse for lip augmentation and correction of upper perioral rhytids. Results showed that eight weeks after injection with Restylane® Kysse, 88% of patients had an increase in volume and fullness to the upper and lower lips and 94% of patients had smoother wrinkles above the lips.
Common side effects include:
- Bruising
- Redness
- Tenderness
- Swelling
- Pain
- Itching
- Lumps/bumps
- Discoloration
When should it not be used?
Restylane® Kysse 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