RESTYLANE® DEFYNE 0.3% LIDOCAINE
Active Substance(s): Hyaluronic acid, lidocaine
Strength: 20mg/ml, 3mg/ml
Pack Size: 1-1ml prefilled syringe
Accessories: Package insert, 2-27G 1/2” needles, 2 traceability labels
Other Known Names: EMERVEL DEEP
WHAT IS RESTYLANE DEFYNE?
Restylane Defyne is a dermal filler designed to correct mild to pronounced deep facial wrinkles and/or folds, targeting marionette lines and nasolabial folds in particular. This product is made of hyaluronic acid gel for maximum lifting capacity and uses specially designed cross-linking XpresHAn Technology for seamless integration with the skin, resulting in natural flexibility and the ability to express a full range of emotion. Manufactured by Galderma as part of the Restylane line of products and formerly known as Emervel Deep, this cosmetic dermal filler rejuvenates the skin and revitalizes the face for a youthful, radiant look with lasting results.
WHAT IS IT USED FOR?
Use this injectable solution for the lower half of the face, targeting the folds that form at the bottom of the nose toward the mouth, and the lines that travel from the corners of the mouth down to the chin. As the skin ages and the hyaluronic acid naturally depletes, these laugh lines, also known as the nasolabial folds and the marionette lines, become more prominent. Restylane Defyne helps to correct these signs of aging by adding volume and restoring moisture to the skin. It is best suited for moderate to severe correction of deep folds and should only be used on patients over the age of 21.
HOW DOES THIS DERMAL FILLER WORK?
Restylane Defyne provides added volume and contouring to facial wrinkles and folds through injection into the mid-to-deep layers of the dermis. Restylane’s specially formulated XpresHAn technology, also known as Optimal Balance Technology, allows the particles in the formula to cross-link with each other for optimal smoothness. With added lidocaine for increased comfort and pain relief, this sterile, viscoelastic, non-pyrogenic gel replaces the hyaluronic acid in the skin that naturally depletes over time. As this substance is found in all living organisms, it is completely biocompatible and is slowly metabolized by the body over time. Due to this gradual process of decomposition, touch ups will be required after a period of time for continued results.
HOW TO INJECT
This product is only to be injected by a licensed medical practitioner and the patient’s medical history should always be disclosed before treatment. Inform your patient of all possible side effects and reactions. Thoroughly wash and prepare the area of treatment with an antiseptic. Use a 27G hypodermic needle. Upon injection, a small amount of the solution should be expressed before a brief break of a couple seconds, in order for the lidocaine to fully take effect. Determine the technique, the depth of injection, as well as the volume of filler based on the patient’s needs. A retrograde liner threading technique or serial puncture technique—or a combination of both—will offer the best results.
Do not inject too superficially so as to avoid any visible lumping or discoloration. Apply the gel slowly with even pressure as you pull the needle slowly backward out of the skin; however, the injection should cease before the needle is pulled out of the skin completely. The manufacturer recommends the use of about 1.4ml per treatment site for the correction of moderate to severe nasolabial folds, and approximately 0.7ml for optimal retreatment. Gently massage the treated area to ensure even distribution.
HOW LONG DOES IT LAST?
The duration of the results vary based on the patient, though they can last up to 12 months on average. In clinical trials, 70% of patients reported continued results after 6 months and 65% of patients reported results up to 12 months. However, results may depend on the individual’s age and lifestyle, as well as the application technique used.
IS THIS PRODUCT SAFE?
Restylane Defyne is sterile and biodegradable, and the safety and effectiveness has been well-established. There are some mild risks associated with the procedure, including risk of infection. The manufacturer does list precautions to keep in mind for safest results, including using caution when treating patients with bleeding disorders or who are undergoing immunosuppressive therapy. It is also suggested not to use this dermal filler on any site that has been treated with permanent implants or on any area other than those indicated. This filler is not recommended to use for patients who are pregnant, breastfeeding, or under the age of 22.
RESTYLANE DEFYNE SIDE EFFECTS
There are some mild side effects or possible reactions that may be experienced by individuals being treated with Restylane Defyne. Side effects typically resolve themselves within a few days, and patients should advise a medical professional if they experience effects lasting longer than 7 days or reactions other than those listed in the informational leaflet. Any unexpected or prolonged reactions should be reported to the manufacturer directly. Several contraindications are listed, and the product should never be used: on individuals with a history of severe allergies or anaphylactic shock; in patients with a history of allergies to gram-positive bacterial proteins or lidocaine; or in areas that show signs of skin disease, such as inflammation, infection or tumors.
The manufacturer also cautions that there may be an increased risk of reactions for individuals who: have a history of severe scarring or pigmentation disorders; have recently received or are planning other laser treatments or chemical peeling near the treatment site; or are on any medications that may prolong bleeding, such as aspirin or warfarin.
COMMON SIDE EFFECTS:
RARE ADVERSE REACTIONS:
- Superficial Necrosis
- Herpetic Eruption
WHAT IS IT MADE OF?
Restylane Defyne is made of hyaluronic acid concentrated to 20mg/ml in a phosphate buffered saline at pH 7. It also contains 3mg/ml lidocaine hydrochloride, which acts as an anesthetic to minimize discomfort during treatment.
Warning! The product is intended solely for professional use in a medical environment and under professional supervision. The product is supplied to medical professionals who specialize in aesthetic medicine (plastic surgery, facial treatments) and work under individual medical licenses as aestheticians or in dedicated clinics. Unprofessional use by individuals without a medical background may lead to severe adverse effects and health harm.