The FDA will make the final decision on Restylane for lip augmentation, but it usually follows the advice of its advisory panels. If the FDA does expand its use, Restylane can be marketed for the lip procedure. FDA approval would make Restylane the first hyaluronic acid dermal filler in the U.S. indicated for use in the lips.

Restylane was the first hyaluronic acid dermal filler approved by the FDA for use in the United States (in 2003). It launched in the U.S. in January 2004, and according to Medicis, it has been used in over 10 million treatments worldwide.

Jonah Shacknai, Chairman and Chief Executive Officer of Medicis, Restylane’s maker, said in a statement that the panel’s recommendation reflects its “confidence in the robust clinical data provided by Medicis.”

Restylane is injected into the tissue and over time is gradually degraded and absorbed by the body; results typically last about six months.

Off-Label Uses of Restylane

Many doctors are already using Restylane for the lips. Doctors can use drugs for off-label uses — meaning, uses that aren’t approved by the FDA — but for a drug maker to market it for a certain purpose, it must have FDA approval.

Plastic surgeon Dr. Farhad Rafizadeh uses Restylane for lip enhancement and said he often recommends it because it stays put and doesn’t seep into other areas of the face as other dermal fillers do. “Restylane allows me to define the shape of the lip in a more precise manner,” he added.

In addition to the lips, common off-label uses for Restylane include the tear trough (the saggy skin under the eyes), marionette lines and facial contouring of the chin, cheeks and temples.

Three injectables won FDA approval in February 2010 for lidocaine versions in the U.S.:

• Juvederm XC
• Restylane-L
• Perlane-L

Dr. Michael H. Gold, a clinical assistant professor of dermatology at Vanderbilt University School of Medicine and School of Nursing, says the products performed similarly to their lidocaine-free predecessors in terms of efficacy and safety.

Furthermore, in the clinical trials, he says, “The incorporation of lidocaine has surely provided a higher comfort level for patients.”

Based on his clinical experience, Dr. Gold says when undergoing an injection that includes even a small percentage of lidocaine, “Most patients say they barely feel the second stick. To me that is the home run of lidocaine in these fillers.”

In the 72-patient trial of Juvederm XC, patients were blindfolded and their nasolabial folds were treated with either Juvederm or Juvederm XC. Patients assessed pain levels during treatment and then 30 minutes and 24 hours post-treatment. In the study, 93 percent reported less pain when treated with the lidocaine formulation versus the non-lidocaine formulation of Juvéderm.

The FDA also cleared a method for doctors mixing lidocaine with Radiesse in July 2009. “Originally, I was against doctors mixing a lot of fillers because I was afraid of potential changes in the products themselves,” says Dr. Gold. But once the FDA clears these products, especially those premixed by manufacturers, “I’m pretty comfortable with it.”
Both Juvederm and Restylane are offered at Dr. Branman’s Little Rock office.

Read the full story from Cosmetic Surgery Times: “Fillers with lidocaine among latest injectable advancements.”

The new line of products contain the same patented NASHA technology used in Restylane injectable filler, an addition that provides a pleasing consistency while preserving moisture and adding luster to the skin.

In a press release, Q-Med explained their intentions with the new skincare line: “The secret to beautiful skin is balanced skin hydration combined with a healthy and protective skin barrier. Restylane Skincare combines these two qualities in an innovative series of creams [that] supplement the effect of injectable Restylane products.”

What is NASHA?

Non-Animal Stabilized Hyaluronic Acid is the secret to Restylane’s success. Hyaluronic acid serves many important functions and in many areas of your body. Because it can bind water, HA hydrates the skin and lubricates the joints. The stabilization process allows Restylane to produce enduring results.

While Restylane and Perlane have been around longer than most wrinkle fillers, they are not the only products containing HA. Products like Prevelle, Hydrelle and others are now widely available for similar purposes. However, according to Q-Med, these fillers are not interchangeable with Restylane.

The least modified competing products are still considerably more chemically changed than the NASHA gels. Competing products are either not as viscous as the NASHA gels, which means that they cannot build and retain volume in the same way, or they are considerably more chemically changed.

The new Restylane product line should be available in Sweden and Europe this summer. If they become available here in Little Rock, we will be sure to let you know.