JUVÉDERM VOLBELLA® XC
In 2016, the U.S. Food and Drug Administration (FDA) approved JUVÉDERM VOLBELLA® XC, for use in the lips for lip augmentation and for correction of perioral rhytids, commonly referred to as perioral lines, in adults over the age of 21.
What is Volbella made of?
JUVÉDERM VOLBELLA® XC is a smooth gel formulation made up of a modified form of HA (Hyaluronic Acid). HA is a naturally occurring sugar found in the human body. The role of HA in the skin is to deliver nutrients and help the skin retain its natural moisture and softness. The gel formulation also contains a small quantity of local anesthetic (lidocaine) which helps minimize discomfort during injection.
In clinical trials, JUVÉDERM VOLBELLA® XC was found to effectively increase lip fullness and soften the appearance of lines around the mouth in a majority of subjects through one year. At three months, 80.3% of patients had at least a 1-point improvement in lip fullness and 96.1% of patients treated with JUVÉDERM VOLBELLA® XC reported improvement in satisfaction with their lips.
JUVÉDERM® Fillers are Number 1
Allergan first debuted this innovative VYCROSS® technology in the U.S. in 2013 with the FDA approval of JUVÉDERM VOLUMA® XC for age-related mid-face volume loss. Now JUVÉDERM VOLBELLA® XC is the latest addition to the JUVÉDERM® collection of fillers, the number one selling collection of dermal filler products in the world, to receive FDA approval.
Optimal treatment may require not only lip augmentation, but also correction of perioral lines. Research shows that patients are actually more interested in treating their perioral lines than their lips, making JUVÉDERM VOLBELLA® XC an especially valuable product.
The safety and effectiveness of JUVÉDERM VOLBELLA® XC has been demonstrated in several clinical trials including the U.S. pivotal study where 168 subjects were treated with JUVÉDERM VOLBELLA® XC. A 5-point scale was used to evaluate the effectiveness of the product for lip fullness and a 4-point scale to evaluate the effectiveness of the product for smoothing lines around the mouth.
Approximately two-thirds of subjects treated with JUVÉDERM VOLBELLA® XC showed improvement in lip fullness and perioral lines through 1 year. At 1 year, 61.8% (76/123) had a 1-point improvement in lip fullness and 66.2% (45/68) had a 1-point improvement in perioral lines severity.
Before and after photos
JUVÉDERM VOLBELLA® XC is available by prescription only.
IMPORTANT SAFETY INFORMATION
This product 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 this product.
• Do not inject into blood vessels. Introduction of this product 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
• In order to minimize the risk of potential complications, this product 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 the lips and perioral area for lip augmentation and correction of perioral rhytids with JUVÉDERM VOLBELLA® 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 VOLBELLA® XC in patients under 22 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 ma experience late onset adverse events with use of dermal fillers, including JUVÉDERM VOLBELLA® XC
- Last 9 months on average
- Volumizes lips and depending on cause may treat dark circles under eyes
- Minimal downtime
- Treats “laugh lines”, “smile lines”, “parentheses” (nasolabial folds), or “marionette lines”
- No allergy skin test required