Galderma / Q-Med AB
Restylane Kysse
A flexible hyaluronic acid filler approved in the US for lip augmentation and upper perioral lines.
Hyaluronic acid dermal fillerReviewed 7/30/2026Source recorded
At a glance
| Primary purpose | Add fullness to the lips and correct upper perioral rhytids in adults over 21. |
|---|---|
| Mechanism | Cross-linked hyaluronic acid gel with lidocaine is injected into lip or upper-perioral tissue to add temporary volume and smooth selected lines. |
| When results appear | Volume is visible immediately; assessment should allow early lip swelling to settle. |
| Typical sessions | One initial treatment with optional touch-up as clinically appropriate. |
| Downtime | Lip-site reactions are very common; swelling, tenderness, bruising, lumps, and firmness may remain visible for days and sometimes longer. |
| Longevity | In the FDA pivotal study, 60% of subjects were responders at week 48; this does not guarantee one-year correction for every patient. |
| Reversibility | May often be reduced with off-label hyaluronidase, but response is variable and complete reversal is not guaranteed. |
| Documented risks | Swelling, bruising, tenderness, pain, lumps, infection, inflammatory reactions, and rare intravascular injection with necrosis, vision impairment, or stroke. |
| Most common disappointment | Swelling can temporarily exaggerate the result, and the product is not designed to replace structural cheek or chin augmentation. |
| Common marketing misconception | A one-year study responder rate is not the same as a guaranteed one-year result. |
| What varies by provider | Lip anatomy, amount, symmetry, injection plane, technique, and management of vascular compromise. |
| Skin-tone considerations | The pivotal study included a Fitzpatrick-skin-type subgroup analysis; individual bruising and pigment response can still vary. |
| When this treatment may not be appropriate | Not appropriate for the Voluma-profile cheek, chin, or temple goals; avoid when label contraindications or active infection apply. |
| United States regulatory status | FDA-approved under PMA supplement P140029/S021 for lip augmentation and correction of upper perioral rhytids in patients over 21. |
| Canadian regulatory status | Health Canada MDALL lists Restylane Kysse under active Class III licence 95283. |
| Evidence status | High for formulation, labelled area, pivotal-study outcomes, and safety; long-term response remains individual. |
Sources
- FDA PMA P140029/S021FDA PMA record · regulatory-primary · supports 2 profile fields
- FDA Summary of Safety and Effectiveness Data P140029/S021FDA SSED · regulatory-primary
- Health Canada MDALL: Q-Med Restylane licencesHealth Canada MDALL · regulatory-primary
- Restylane Kysse Instructions for Useofficial manufacturer IFU · manufacturer-primary · supports 15 profile fields
- Restylane Kysse Patient Safety Informationofficial manufacturer patient labelling · manufacturer-primary · supports 8 profile fields
Related comparisons
See average treatment prices near you
Enter a US ZIP code or Canadian postal code to check our stored estimate for the surrounding market.