Restylane is a FDA-approved dermal filler made of a biodegradable, non-animal stabilized hyaluronic acid (NASHA). Hyaluronic acid is a natural substance found in all living organisms and provides volume and fullness to the skin.
Restylane is a gel of hyaluronic acid generated by Streptococcus species of bacteria. It is produced biotechnologically by natural fermentation in a sterile laboratory environment. This significantly diminishes the risk of transmitting diseases between species or of eliciting allergic reactions in patients who are sensitive to common foods, such as beef, chicken and eggs. Restylane does not require any allergy or skin test prior to injection.
Restylane is indicated for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Restylane is also indicated for submucosal implantation for lip augmentation in patients over the age of 21.
Restylane is formulated as a clear gel and uses a dual mechanism of action to correct moderate to severe wrinkles and folds. Upon being injected beneath the skin’s surface, Restylane gel integrates into dermal tissue then attracts and binds to water molecules to help maintain volume. Restylane is gradually degraded by the body’s own mechanism and disappears without any residue. Results can be seen immediately following Restylane treatment and for up to six months. Some patients may achieve results that last longer than six months, depending upon injection site.
Restylane is a gel of hyaluronic acid generated by a Streptococcus species of bacteria. As opposed to other hyaluronic acid products, NASHA is not derived from animal sources. It is produced biotechnologically by natural fermentation in a sterile laboratory environment. This significantly diminishes the risk of transmitting diseases between species or of eliciting allergic reactions in patients who are sensitive to common foods, such as beef, chicken and eggs. Restylane does not require any allergy or skin test prior to injection.
Restylane is also marketed and sold in more than 65 countries outside the United States where it has been used in more than ten million procedures.
Restylane is contraindicated:
- in patients with severe allergies, including allergies to gram positive bacterial proteins
- in patients with bleeding disorders
- for implantation in anatomical spaces other than the dermis or submucosal implantation for lip augmentation
- Delay use of Restylane at sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present
- Short-term minor or moderate (7-14 days) injection site reactions to Restylane have been observed. Injections of greater than 1.5 mL per lip (upper or lower) per treatment session significantly increases the occurrence of injection site reactions. If a volume of more than 3 mL is needed to achieve optimal correction, a follow-up treatment session is recommended.
- Restylane must not be implanted into blood vessels
- Delayed onset inflammatory papules have been reported following the use of dermal fillers. Inflammatory papules that may occur rarely should be considered and treated as a soft tissue infection
Side effects may include:
- Injection site scabbing
Rare Post-Marketing Serious Adverse Events
- Delayed hypersensitivity reactions
- Immediate-onset allergic reactions and anaphylactic shock
- Vascular accidents and necrosis
For complete administration, dosing and safety information refer to the manufacturers package labeling for Restylane.