If you are unhappy with the sudden appearance of wrinkles, fine lines, sunken in cheeks and other common signs of aging, you might look to one or more of these to fill out those lines and plump up your cheeks or lips. They are called dermal fillers and that’s exactly what they do, fill out your skin. Dermal fillers and injectables, like the ever popular Botox, have become almost commonplace these days, all but replacing the scalpel and expensive surgical procedures by presenting a virtually painless, quick fix that can be catered to each patient’s individual needs.

Every dermal filler on the market has its strengths and weaknesses. Juvederm can fill in wrinkles, folds and improve that overall appearance of lose, sagging skin, but where Juvederm is more superficial and can be used almost anywhere, Juvederm Ultra volumizes deeper and is best used in specific areas. Restylane works best on fine lines and wrinkles. Juvederm Ultra Plus’ gel particles are bigger and can be injected deeper into the skin for a more long lasting result that may be sustained for up to 12 months. Most dermal fillers take only minutes to apply and last for a couple of months.

JUVÉDERM VOLUMA® XC, JUVÉDERM® XC, and JUVÉDERM® Ultra XC Important Information

Indications

JUVÉDERM VOLUMA® XC injectable gel is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face in adults over the age of 21.

JUVÉDERM® XC injectable gels (JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC) are indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).

JUVÉDERM® Ultra XC injectable gel is indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.

Important Safety Information

Do not use if you have a history of severe allergies/allergic reactions, or are allergic to lidocaine or gram-positive bacterial proteins used to make these products. The safety of use while pregnant or breastfeeding has not been studied. The safety for use in patients with excessive scarring or pigmentation disorders has not been studied and may result in additional scars or pigmentation changes. Unintentional injection into a blood vessel can occur and, while rare, could result in serious complications which may be permanent. These include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring. Tell your doctor if you are on medications to decrease the body’s immune response or prolong bleeding, such as aspirin, ibuprofen, or blood thinners. There is a risk of infection from skin injection procedures.

Contraindications

These products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to gram-positive bacterial proteins or lidocaine contained in these products.

Warnings

• Do not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, inject the product slowly and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur

• Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled

Precautions

• In order to minimize the risk of potential complications, these products should only be used by healthcare professionals who have appropriate training, experience, and knowledge of facial anatomy

• Healthcare professionals are encouraged to discuss the potential risks of soft-tissue injections with their patients prior to treatment and ensure that patients are aware of signs and symptoms of potential complications

• The safety and effectiveness for the treatment of anatomic regions other than moderate to severe facial wrinkles and folds with JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC, the lips and perioral area for lip augmentation with JUVÉDERM® Ultra XC, and the mid-face with JUVÉDERM VOLUMA® XC, have not been established in controlled clinical studies

• As with all transcutaneous procedures, dermal filler implantation carries a risk of infection. Follow standard precautions associated with injectable materials

• The safety for use during pregnancy, in breastfeeding females, and in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied

• The safety for use of JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC in patients under 18 years has not been established

• The safety for use of JUVÉDERM VOLUMA® XC in patients under 35 or over 65 years has not been established

• Use with caution in patients on immunosuppressive therapy

• Patients who are using products that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites

• If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or if the product is administered before the skin has healed completely, there is a possible risk of an inflammatory reaction at the treatment site

• Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events

• The safety of JUVÉDERM VOLUMA® XC injectable gel for use in patients with very thin skin in the mid-face has not been established

• Patients may experience late onset nodules with use of dermal fillers, including JUVÉDERM VOLUMA® XC

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Adverse Events

The most commonly reported side effects for JUVÉDERM® XC injectable gels were temporary injection-site redness, swelling, pain/tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® Ultra XC or JUVÉDERM® Ultra Plus XC, they were mostly mild or moderate in severity, with a duration of 14 days or less; and for JUVÉDERM VOLUMA® XC, they were predominantly moderate in severity, with a duration of 2 to 4 weeks.