"Our physician customers have told us perioral lines are difficult to treat and are also a top concern among patients," said David Moatazedi, Senior Vice President US Medical Aesthetics. "We developed a soft, smooth gel appropriate for adding subtle volume to the lips and softening the appearance of perioral lines to address this specific need. We are committed to providing our doctors with products to address the evolving needs of their aesthetically-oriented patients."
According to the American Society of Plastic Surgeons (ASPS), use of soft tissue fillers in 2015 was the fastest growing cosmetic minimally-invasive procedure.3 JUVÉDERM VOLBELLA® XC is approved specifically for the lips and perioral rhytids. JUVÉDERM VOLBELLA® XC is formulated with VYCROSS®,2 a proprietary filler technology from Allergan, which yields smooth products that have been engineered to address specific patient concerns.4 " The most common side effects observed in clinical trials were temporary responses at the treatment site such as swelling, tenderness, bruising, firmness lumps/bumps, redness, pain, discoloration, itching and dryness. Most of these side effects resolved within 30 days.2
JUVÉDERM VOLBELLA® XC is now available for purchase by physicians who have completed an online training program. Physicians can find information about injection technique and complete the online training by visiting www.VolbellaTraining.com.
Consumers can learn more about JUVÉDERM VOLBELLA® XC and the JUVÉDERM® collection of fillers or find a doctor in their area by visiting www.juvederm.com.
JUVÉDERM VOLBELLA® XC Important Information
JUVÉDERM VOLBELLA® XC injectable gel is for injection into the lips for lip augmentation and for correction of perioral lines in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive JUVÉDERM VOLBELLA® 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 Gram-positive bacterial proteins used in these products.
What precautions should my doctor advise me about?
- Tell your doctor if you are pregnant or breastfeeding. The safety of JUVÉDERM VOLBELLA® XC for use during pregnancy or while breastfeeding has not been studied
- The safety of JUVÉDERM VOLBELLA® XC in patients under 22 years has not been studied
- The safety and effectiveness of JUVÉDERM VOLBELLA® XC in areas other than the lips and perioral area have not been established in controlled clinical studies
- Tell your doctor if you have a history of excessive scarring (eg, hypertrophic scarring and keloid formations) or pigmentation disorders, as use of JUVÉDERM VOLBELLA® XC 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 JUVÉDERM VOLBELLA® XC 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 common side effects include swelling, tenderness, bruising, firmness, lumps/bumps, redness, pain, discoloration, itching, and dryness. Most side effects are mild or moderate and last 30 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.
To report a side effect with JUVÉDERM VOLBELLA® XC, please call Allergan at 1-800-433-8871. Please also visit Juvederm.com for more information.
Available by prescription only.
© 2016 Allergan. All rights reserved. All trademarks are the property of their respective owners.
1. JUVÉDERM VOLBELLA® XC Directions for Use, 2016.
2. JUVÉDERM VOLBELLA® XC Patient Labeling, 2016.
3. American Society of Plastic Surgeons 2015 National Clearinghouse of Plastic Surgery Procedural Statistics, 2015. "2015 Cosmetic Plastic Surgery Statistics Cosmetic Procedure Trends."
4. Data on File VYCROSS™: An Innovative Dermal Filler Technology, 2013.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company's R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development.
Our Company's success is powered by our more than 16,000 global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
For more information, visit Allergan's website at www.Allergan.com.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 (such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
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SOURCE Allergan plc