Juvéderm Vollure™ XC

APPROVED USES

JUVÉDERM VOLLURE™ XC injectable gel is for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds in adults over the age of 21.

IMPORTANT SAFETY INFORMATION

Are there any reasons why I should not receive JUVÉDERM VOLLURE™ XC injectable gel?

Do not use this product if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or the Gram-positive bacterial proteins used in this product.

What precautions should my doctor advise me about?

  • Tell your doctor if you are pregnant or breastfeeding. The safety of this product for use during pregnancy or while breastfeeding has not been studied
  • The safety of JUVÉDERM VOLLURE™ XC in patients under 22 years has not been studied
  • The safety and effectiveness of JUVÉDERM VOLLURE™ XC in areas other than facial wrinkles and folds have not been established in clinical studies
  • Tell your doctor if you have a history of excessive scarring (e.g., hypertrophic scarring and keloid formations) or pigmentation disorders, as use of this product may result in additional scars or changes in pigmentation
  • Tell your doctor if you are planning other laser treatments or a chemical peel, as there is a possible risk of inflammation at the treatment site if these procedures are performed after treatment
  • Patients who experience skin injury near the site of injection with this product may be at a higher risk for side effects
  • Tell your doctor if you are on immunosuppressive therapy used to decrease the body’s immune response, as use of this product may result in an increased risk of infection
  • Tell your doctor if you are using medications that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners, as this may result in increased bruising or bleeding at the injection site
  • Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment

What are possible side effects?

The most commonly reported side effects with JUVÉDERM VOLLURE™ XC injectable gel included injection-site redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. Most side effects were mild or moderate and lasted 7 days or less.

One of the risks with using this product is unintentional injection into a blood vessel, and, while rare, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring.

As with all skin injection procedures, there is a risk of infection.