Fillers (Juvederm products, Radiesse, Belotero)
Indications and Important Safety Information
JUVÉDERM VOLUMA® XC, JUVÉDERM® XC, and
JUVÉDERM® Ultra XC Important Information
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
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.
• 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
• 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
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.
To report an adverse reaction with JUVÉDERM® Ultra XC, JUVÉDERM®
Ultra Plus XC, or JUVÉDERM VOLUMA® XC, please call Allergan Product Surveillance at 1-800-624-4261.
For more information, please see JuvedermDFU.com or call the Allergan Medical Information line at 1-800-433-8871.
JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM VOLUMA® XC injectable gels are available by prescription only.
Restore a more youthful look to your appearance with RADIESSE®, a volumizing filler. It provides instant lift, softening the appearance of wrinkles and folds while stimulating the growth of your own collagen.
Refresh your look today with RADIESSE which is FDAapproved for correction of moderate to severe facial wrinkles and folds, such as nasolabial fold.
RADIESSE, a volumizing filler, provides long-lasting and natural results by immediately restoring lost volume. It’s ideal for correcting the following facial areas:
- Smile lines, also called nasolabial folds, run from the sides of the nose to the corners of the mouth. Deep smile lines can give your face a tired and aged expression.
- Marionette lines, which begin at the corners of the mouth and extend down toward the chin. These lines can make you look like you’re scowling, even when you’re not.
- Corners of the mouth can begin to turn downward, giving the look of being tired, angry, or sad.
- Pre-jowl Folds form along the jaw-line. This area can look hollow as volume loss causes the skin to sag along your jawline and create folds.
- Chin wrinkles are lines across your chin that can distract from your smile and make you look older.
RADIESSE IMPORTANT SAFETY INFORMATION
Contraindications: RADIESSE injectable implant is contraindicated for patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies; patients with known hypersensitivity to any of the components; and patients with bleeding disorders.
Warnings: Use of RADIESSE in any person with active skin inflammation or infection in or near the treatment should be deferred until the inflammatory or infectious process is controlled. RADIESSE can cause injection reactions consisted mainly of short-term bruising, redness and swelling. RADIESSE should not be injected into the blood vessels.
Do not overcorrect (overfill) a contour deficiency with RADIESSE because the depression should gradually improve within several weeks as the treatment effect of RADIESSE occurs. The safety and effectiveness for use in the lips has not been established. There have been published reports of nodules associated with the use of RADIESSE injected into the lips.
Precautions: RADIESSE contains calcium hydroxylapatite (CaHA) particles that are radiopaque and are clearly visible on CT Scans and may be visible in standard, plain radiography. Safety of RADIESSE beyond three years has not been evaluated. The safety of RADIESSE in patients with a susceptibility to keloid formation and hypertrophic scarring has not been studied. Safety and effectiveness in the periorbital area or with concomitant dermal therapies or other drugs or implants has not been established.
As with all skin-injection procedures, there is a risk of infection with RADIESSE. Safety of RADIESSE for use during pregnancy, in breastfeeding females or in patients under 18 years has not been established.
Patients who are using medications that can prolong bleeding, such as aspirin or warfarin, may experience increased bruising or bleeding at the injection site. Patients should inform their physician if they are using such medications.
Interactions between RADIESSE with drugs or other substances or implants have not been evaluated. Patients should minimize exposure of the treated area to extensive sun or heat exposure for approximately 24 hours after treatment or until any initial swelling and redness has resolved.
RADIESSE is for Single Patient Use Only. Do not use if needle is bent, discard it and complete the procedure with a replacement needle. Do not re-shield used needles. Discard needles and syringes as if potential biohazards. Patients with a history of previous herpetic eruption may experience reactivation of the herpes.
Adverse Events: The most common serious adverse events that have been seen with RADIESSE when injected into the nasolabial folds include necrosis, allergic reaction, edema and infection. Common side adverse events with RADIESSE are generally mild in nature and short in duration and include bruising, redness, swelling, pain, itching and other local side effects. To report a problem with RADIESSE, please call Customer Service at 1-866-862-1211.
For complete Safety Information please refer to the Instructions for Use document at www.radiesse.com.
RADIESSE treatments are a quick in-office procedure at The Science of Beauty in Bradford, PA. In fact, your comfort can be significantly improved during the procedure because RADIESSE (+) is pre-mixed with an anesthetic called lidocaine for an enhanced treatment comfort. RADIESSE (+) comes from the same family of fillers as RADIESSE and it’s a robust filler that is ideal for restoring volume and smoothing wrinkles and folds in the lower face.3 Treatments are usually completed in about 30 minutes. Because little to no downtime is required, it’s likely you’ll be free to return to your regular daily routine right afterwards. And because the results are immediate, you can leave the office looking more refreshed.
For detailed information about RADIESSE, visit www.radiesse.com
Help take your wrinkles all the way to smooth with BELOTERO BALANCE.2
Treatments: BELOTERO BALANCE is FDA-approved for injection into the mid to deep dermis to temporarily smooth out and fill in moderate-to-severe facial wrinkles and folds, such as nasolabial folds (the folds that go from the side of the nose to the corner of the mouth).2
BELOTERO BALANCE specifically treats highly visible areas around the mouth, improving the appearance of stubborn, etched-in facial lines and wrinkles. Treatment areas include2:
- Vertical lip lines†
- Smiles lines†
- Corner lines†
- Moderate nasolabial folds
- Chin wrinkle†
†When wrinkle or fold is treated to full correction. Individual results may vary.
BELOTERO BALANCE integrates directly into the skin, enhancing your appearance with minimal downtime.2
Important Safety Information for RADIESSE® and BELOTERO BALANCE®
RADIESSE should not be used in patients with bleeding disorders or in patients with severe allergies manifested by a history of anaphylaxis, with a history or presence of multiple severe allergies or with a history of hypersensitivity to the components of RADIESSE.
BELOTERO BALANCE should not be used in patients with a history of allergic reactions, including allergies to gram positive bacterial protein.
Neither RADIESSE nor BELOTERO BALANCE should be injected into blood vessels.
As with all skin-injection procedures, there is a risk of infection with RADIESSE, as well as BELOTERO BALANCE. Use of RADIESSE or BELOTERO BALANCE in any person with active skin inflammation or infection in or near the treatment area should be deferred until the inflammatory or infectious process has been controlled.
The safety and effectiveness of neither RADIESSE, nor BELOTERO BALANCE, during pregnancy or breastfeeding has been established.
The safety and effectiveness of RADIESSE use in the lips, periorbital area, in patients under 18, or in patients with a susceptibility to keloid formation and hypertrophic scarring has not been established. Radiesse patients with a history of previous herpetic eruption may experience reactivation of the herpes.
The safety or effectiveness of BELOTERO BALANCE for the treatment of dermal contour defects other than nasolabial folds, such as use in the lips, or in patients under 21 years has not been established.
Injection site responses to BELOTERO BALANCE have been observed, consisting mainly of short-term inflammatory symptoms starting early after treatment and with 7 days duration or less.
Laser treatment, chemical peeling, or any other procedure based on active dermal response performed after treatment with BELOTERO BALANCE may increase the risk of an inflammatory reaction at the injection site.
Patients using medications that prolong bleeding, such as aspirin or warfarin, may experience increased bruising and bleeding at the injection site. Exposure of the treated area to excessive sun, UV lamp exposure, and extreme cold weather should be minimized until any initial swelling and redness have resolved and puncture sites have healed.
For full safety information, please visit WWW.RADIESSE.COM and WWW.BELOTERO.COM
BELOTERO BALANCE® Frequently Asked Questions
Is this like a botulinum toxin treatment?
No, BELOTERO BALANCE acts in a totally different way. It fills in areas in the skin to reduce the depth of wrinkles, lines, and folds. The skin remains mobile and flexible, with a natural look, feel, and movement.
How does it work?
BELOTERO BALANCE is made of a material called hyaluronic acid, also known as HA, that comes in the form of a smooth gel. When it is injected beneath the skin, it fills in small gaps in the tissue. This smoothes the wrinkles, folds, and lines, for immediate correction that looks and feels natural.
How soon can I expect results?
Instantly! Immediately upon treatment, BELOTERO BALANCE helps smooth etched-in lines and wrinkles, such as vertical lip lines above and around your lips.
How long does it last?
Individual results may vary, but BELOTERO BALANCE may last about 6 months or more.1 Some factors that affect how long it lasts are the amount of product used and the area it is injected into. In areas that experience a lot of movement due to eating, talking, and smiling, the product may not last as long as other less active areas.
How much do I need?
Just as wrinkles and folds vary from face to face, so does the amount of BELOTERO BALANCE needed per treatment. It’s very individual, depending on the amount of correction desired, the number of areas to be treated, and other factors. We can estimate better once we have a consultation about your individual needs.
Is it safe?
BELOTERO BALANCE is FDA-approved and has undergone testing in a clinical study to prove its safety.1 Hyaluronic acid products for skin correction have been available for a long time and used in thousands of treatments.
54 Boylston St.
Bradford, PA 16701
54 Boylston St.
Bradford, PA 16701