Juvederm Volbella® XC

An exciting new dermal filler is now approved for use in the United States. JUVÉDERM VOLBELLA® XC, by Allergen, has been approved by the United States Food and Drug Administration (FDA) for individuals over the age of 21 years. JUVÉDERM VOLBELLA® XC is indicated for the correction of lines around the mouth and for increasing lip fullness, for up to one year. In fact, this product is the first and only FDA-approved dermal filler that has been shown to provide these outcomes and last for such a long duration. Jeunenu is proud to be one of the first places to offer this exciting and innovative treatment.

Indications for use

Like other dermal fillers, JUVÉDERM VOLBELLA® XC restores lost facial volume and diminishes the appearance of facial lines by filling and plumping the skin in specific, localized areas. This product works to reduce signs of aging in a minimally invasive approach to age management. The problem with some dermal fillers is that they can give unnatural results, with too much volume or unpleasant lack of facial movement. Another issue with some fillers is that the results may be beautiful, but they only last several months.

Patients are looking for a product that can effectively correct for facial lines and give lasting results. Additionally, patients are looking for a product that can give smooth, subtle and beautifully enhanced lip augmentation results. They are looking for a beautifully natural lip, one that is not drastic nor artificial looking. Fortunately, that product is here. JUVÉDERM VOLBELLA® XC softens the lines around the mouth, while adding beautiful and natural fullness to the lips.

JUVEDERM VOLBELLA® XC has been approved for individuals over age 21 years for the correction of perioral rhytids and augmentation of lip fullness.

Unfortunately, as we age, the face begins to lose volume, resulting in noticeable age lines, sunken in cheeks and thinning of the lips. Many of these changes are due to normal aging, genetics and environmental factors. The skin becomes less elastic and loses moisture. This contributes to the formation of wrinkles of the face, particularly around the nose and mouth.

Perioral Rhytids

Rhytids are wrinkles in the skin. Perioral indicates that the wrinkles are located around the mouth. Beauty products in the form of moisturizers and serums can help to moisturize the skin on the surface. However, they cannot treat the deep dermal layer of skin. JUVEDERM VOLBELLA® XC adds volume to smooth the facial lines from deep in the skin.

Lip fullness

Lip augmentation is a procedure intended to improve the appearance of the lips by increasing their fullness. Full lips have long been associated with beauty and youth. It is no wonder, as our lips lose fullness and volume with age. Some individuals notice thinning of the lips over time, while others simply want to increase naturally thin lips. The new JUVEDERM VOLBELLA® XC can give subtly enhanced and naturally beautiful lips.

Technology

JUVÉDERM VOLBELLA® XC is a technologically advanced and modern dermal filler. It is formulated with VYCROSS® technology. VYCROSS® blends different molecular weights of hyaluronic acid, which contributes to the filler’s increased duration, lasting up to one year. This product uses a lower concentration of hyaluronic acid (15 mg/ml), contributing to the soft and smooth texture of this gel. Hyaluronic acid is a complex sugar that is naturally found within the human body, hydrating the skin and increasing volume within the skin layers.

As our bodies age, we naturally lose the ability to produce sufficient hyaluronic acid, which leads to facial lines and lost facial volume. The role of hyaluronic acid acting as a filler is to act as a plumping substance for restoring facial volume and moisture. The beauty of hyaluronic acid as an injectable, is that there is less risk of allergic reaction, as the substance is a naturally occurring complex in the body.

VYCROSS® Technology

The advanced VYCROSS® technology was first introduced for use in the United States when JUVÉDERM VOLUMA® XC was approved for age-related volume loss of the mid-face and cheeks. This product has now been widely adapted and used at Jeunenu, and throughout the country as well. The VYCROSS® technology creates smooth injectable products, specifically engineered to address patient concerns of lip and facial volume, as well as perioral lines. This formulation provides long-lasting results that patients and clinicians have come to expect from the JUVÉDERM collection of dermal fillers. The JUVÉDERM family of dermal fillers is the number one selling collection in the world.

Other JUVÉDERM products include:

1. JUVÉDERM VOLUMA® XC: This injectable gel is indicated for deep injection to the cheek area, correcting for age related loss of volume in the face.

2. JUVÉDERM® XC: This injectable gel is indicated for correction of moderate to severe facial wrinkles and lines.

3. JUVÉDERM® Ultra XC: This injectable is indicated for injection into the lips and around the mouth to increase lip fullness and correct for lines around the mouth.

And now added to this respected list, JUVEDERM VOLBELLA® XC. The excitement over this product lies in the fact that the clinician and patient now have a soft and subtle filler with such lasting results.

Clinical Trial

The effectiveness and safety of this new dermal filler has been studied in several clinical trials as part of the process to gain FDA approval. In a pivotal study performed in the United States, 168 patients were treated with JUVÉDERM VOLBELLA® XC to study the effectiveness of the product in delivering expected outcomes, as well as the safety for patient use. Lip fullness was evaluated using a five point scale and the smoothing of perioral lines was evaluated using a four point scale. The results of the study found that the majority of the patients that were treated with JUVÉDERM VOLBELLA® XC showed improved lip fullness and reduction of lines through one year duration. Patient safety was found to be similar to that of the control group, indicating that the injection was safe for patient use. The most common side effects included temporary redness, swelling, lumps, and tenderness to the treatment site that typically resolved within thirty days.

JUVÉDERM VOLBELLA® XC has been used outside the United States for several years. It was first approved in Europe in 2011 and is currently distributed to more than 70 countries worldwide. The approval of JUVÉDERM VOLBELLA® XC demonstrates the commitment that Allergen has to developing advanced technologies and product to allow clinicians to address the needs of their patients. This approval brings a new type of filler that is unlike anything else to the United States.

What to Expect with JUVÉDERM VOLBELLA®

Treatments

If considering JUVÉDERM VOLBELLA® XC to address concerns related to lip volume or facial lines around the mouth, the first step is to meet with Jeunenu team and the clinical team at Jeunenu for an individualized consultation. During the consultation, the patient will have the opportunity to relay concerns and desired outcomes. Additionally, Jeunenu team will have the opportunity to evaluate the patient and determine an appropriate treatment plan. The patient may need to discontinue the use of certain medications before injection due to risk of bleeding. However, for most patients, there is little preparation needed before an injection with JUVEDERM VOLBELLA® XC.

During the procedure, the treatment area around the mouth will be slightly numbed with lidocaine, a local anesthetic. This is done to reduce discomfort during injection. The JUVEDERM VOLBELLA® XC is injected into the skin through a syringe needle. The entire process typically takes only 20-30 minutes, depending on how many injection sites are needed. Jeunenu Dr will determine what injection locations are appropriate as well as what volume of gel to inject in each site.

There is usually little recovery needed after the procedure. Side effects can include temporary swelling, redness, discomfort, lumps and itching to the treatment site, which generally subside within several days. JUVÉDERM VOLBELLA® XC should not be used by patients who have severe allergies or those with a known allergy to gram-positive bacterial proteins or lidocaine.