The US Food and Drug Administration (FDA) has approved Juvéderm Voluma XC(Allergan) to correct age-related volume deficits in the midface in adults aged 21 years and older, the company has announced.

Juvéderm Voluma XC is a gel composed of cross-linked hyaluronic acid suspended in phosphate-buffered saline with 0.3% lidocaine. It is the first dermal filler approved in the United States specifically for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the midface.
As reported by Medscape Medical News, the FDA’s General and Plastic Surgery Devices Panel unanimously agreed that Juvéderm Voluma XC is effective and safe and that the benefits outweigh the risks, according to the clinical trial data presented to the panel.
“As people age, the cheek area can lose volume, causing the cheeks to flatten out and the skin to droop and sag,” Derek H. Jones, MD, said in a company news release announcing the approval. Dr. Jones is associate professor of dermatology at the University of California, Los Angeles; founder and medical director of Skin Care and Laser Physicians of Beverly Hills; and clinical investigator in the Juvéderm Voluma XC pivotal study.
In the study, “physicians and patients were able to see instant and visible results, including correction of age-related volume loss in the cheek area and a more youthful appearance to the face,” Dr. Jones said.
JUVEDERM VOLUMA(TM) XC is made with Allergan’s proprietary VYCROSS(TM) technology, an advanced manufacturing process that results in a smooth gel that flows easily and consistently. This unique formulation contributes to the lift capacity to correct volume loss in the cheek area and to the duration of the product.(2,3) Additionally, JUVEDERM VOLUMA(TM) XC contains a small amount of lidocaine which helps to numb the treatment area during the injection procedure. The JUVEDERM VOLUMA(TM) formulation without lidocaine was first introduced in Europe in 2005. JUVEDERM VOLUMA(TM) with lidocaine was first introduced outside the U.S. in 2009. As of August 31, 2013, JUVEDERM VOLUMA(TM) with lidocaine (branded as JUVEDERM VOLUMA(TM) XC in the U.S.) is distributed in 72 countries, including markets in Europe, Latin America, Middle East, Asia Pacific, and Canada. The JUVEDERM(R) family of products, including JUVEDERM(R) Ultra and Ultra Plus, are marketed and sold in 85 countries outside the United States.(4)
The most common adverse effects observed in the clinical trial included temporary injection-site tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. The adverse effects were predominantly moderate (uncomfortable) in severity and lasted 2 to 4 weeks.
Juvéderm Voluma XC will soon be available at Dr. Mark Bishara’s office.  We will keep everyone updated when the product will be available in both of our Mansfield and Southlake offices.
This news is brought to you courtesy of Dr. Mark Bishara and The Paragon Plastic Surgery & Med Spa


What is JUVÉDERM VOLUMA™ XC injectable gel?

JUVÉDERM VOLUMA XC injectable gel is the first and only filler FDA-approved to instantly add volume to the cheek area.Juvederm Voluma is the Juvederm specialty product for volumizing. It is designed for injection in the deep dermis to treat age-related facial volume loss. Voluma has the optimal thickness of a volumizer while still retaining the smooth nature of the Juvederm family.
It gives you a subtle lift, helping to restore contour and for a more youthful profile, for up to 2 years, in patients over the age of 21. It’s different than JUVÉDERM® XC and works on a different area of the face. JUVÉDERM® XC smoothes out moderate to severe wrinkles and folds around the nose and mouth, like parentheses. JUVÉDERM VOLUMA XC, however, adds volume to the cheek area.
What else should you know about JUVÉDERM VOLUMA XC?

  • First and only Hyaluronic Acid (HA) filler FDA-approved to instantly add volume to the cheek area, resulting in a subtle lift
  • Clinically proven to last up to 2 years with optimal treatment
  • JUVÉDERM VOLUMA XC is from the makers of the #1 family of fillers
  • After 24 hours, you should be able to resume your normal activities
  • Side effects are moderate and generally last 2 to 4 weeks. Common side effects include temporary reactions at the treatment site such as tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching.

Hyaluronic Acid (HA) is a naturally occurring, hydrating substance found in your skin. As you age, you start to lose HA, which causes the skin to lose structure and volume.
Dr. Mark Bishara offers minimally invasive procedures for patients. These treatments are designed to provide subtle enhancements that can improve your targeted problem areas, while allowing you to return to work and your regular activities the very same day. Dr. Bishara is proud to offer a wide range of enhancing, minimally invasive procedures such as Botox, Xeomin, Juvederm Ultra Plus XC and Radiesse.  Juvederm Voluma XC will be available soon. We will keep you updated or call our office for more information at (817) 473-2120.
Rewards Program:
Dr. Bishara and The Paragon Med Spa are proud to offer the Brilliant Distinctions Program for our patients. All you have to do is earn points for your purchase from our particiapting providers, including Botox and Juvederm.  Then start saving by redeeming points per treatment for instant savings off your next purchase.
For example:  For 1 Botox/Juvederm cosmetic treatment you earn 200 points (a $20 Value)
For more information on participating in this program visit

Juvederm Voluma is the newest hyaluronic acid soft tissue filler to the Juvéderm family. As the name suggests, it is used to replace volume to the tissues of the face. Replacing the volume that has been lost through aging can help to restore a more youthful appearance.
Many times, we focus on superficial wrinkles and skin texture. While important, these issues are only part of the effects of aging. Bringing back the contours of the cheeks and chin that start to flatten as we age can do wonders for the overall appearance of the face. Along with treating wrinkles and skin texture, replacing volume creates a foundation beneath the surface to support the skin and diminishes the look of the lines and wrinkles that come with aging.

Frequently Asked Questions:

1. What is Juvederm Voluma? Juvederm Voluma is the Juvederm specialty product for volumizing. It is designed for injection in the deep dermis to treat age-related facial volume loss.
2. How is Juvederm Voluma different from the rest of the family? it is a thick, robust product ideal for injection in the deep dermis to treat age-related facial loss. This product produces an extremely optimal lift that is still smooth and cohesive.
3. Where is Juvederm Voluma intended to be used? Juvederm Voluma is indicated for volumizing of the cheeks, cheekbones, and chin.
4. Can Juvederm Voluma be injected into the lips? No. Because it is such a thick, viscous product, Juvederm Voluma is not appropriate for injection into the lips. Other products in the Juvederm family (such as Ultra or Ultra Plus) are optimally suited for treatment of the lips.
5. Is Juvederm Voluma injected the same as other Juvederm products? Voluma can be injected through either a needle or a cannula; both are supplied with the product. Regardless of physician choice (needle or cannula), careful training and experience are recommended to become familiar with injecting Voluma.
6. How long does Juvederm Voluma last? Clinical trials show the volumizing results of Voluma to last up to 18-24 months.
7. What are the adverse reactions with Juvederm Voluma? The types of adverse events Voluma demonstrates are consistent with other volumizers, but in very low rates.
8. Who is the appropriate patient for Voluma? Patients who can benefit from Voluma are patients with age-related facial volume loss, which may have resulted in a sunken look or facial asymmetry. (One thing to note is that patients with sagging skin are not good candidates for Voluma-these patients may be better served by surgery.)
12. Why should I use Voluma for volumizing as opposed to another Juvederm product? Voluma is specially designed for true volumizing, with deep dermis injections of the product to volumize cheeks, cheekbones, and chin.
This news is brough to you courtesy of Dr. Mark Bishara and The Paragon Med Spa in Mansfield and Southlake. (817) 473-2120