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.
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 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 mid-face have not been established in controlled clinical studies
• The safety for use during pregnancy and in breastfeeding females has not been established
• The safety for use in patients under 35 or over 65 years has not been established
• As with all transcutaneous procedures, dermal filler implantation carries a risk of infection. Follow standard precautions associated with injectable materials
• The safety for use in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
• 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
• Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events
• The safety 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
Side effects in > 5% of subjects were temporary injection-site tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. They were predominantly moderate in severity, with a duration of 2 to 4 weeks.
To report an adverse reaction, please call Allergan Product Surveillance at 1-877-345-5372.
JUVÉDERM VOLUMA® XC injectable gel is available by prescription only.
I've been a patient of Dr. Kushner for years now, but I just visited the Farmingdale office for the first time. I had an amazing experience: the office is clean, crisp, and brightly lit. The office staff are friendly and helpful. My wait was negligible and as always, Dr. Kushner addressed my issue in a professional and efficient manner. Highly recommend
I love the accommodations and the heart felt care this office provides there patients. I have a very hectic work and mom schedule and they have always been able to work around my schedule. (Especially weekend office hours) On my most stressfull days with my illness they have always attended with kindness and concern for my care. Pharmacies have always been called the minute you are done with your office visit. Which shows me a prompt and responsible treatment they provide to there patients.
Dr Kushner has always been kind, dedicated and a fantastic doctor. I wouldn’t go anywhere else I took my husband who is in a wheelchair and cannot walk for a small procedure. Dr Kushner was patient and total professional with him Highly recommend Dr Kushner
The lady at the front desk, as well at the PA/MA were so great! I was very pleased with the PA, she was so nice, very honest and professional, specially in this time and date we need more medical professionals like her. I love your practice so much that I brought my daughter there, and made an appointment for my mother too who lives in Queens. Keep up the good work!
Love Doctor Kushner and her staff. I am a new patient and I was very pleased with my visit with her. Very patient, Dr Kushner took her time with me, I did not feel rushed. I love her pleasantness. Her staff is very pleasant and responsive to any questions you may have. Office is clean
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