FDA Approval Obtained For Treating Mid Face Using Cannula

Galderma Laboratories, a medical solution provider in skin health, announced in November 2018 that it has received U.S. Food and Drug Administration (FDA) approval for the use of Restylane Lyft, one of their most popular Hyaluronic Acid (HA) dermal filler, with a cannula for cheek augmentation and the correction of age-related mid-face contour deficiencies in patients over the age of 21.

For those who are unaware, a cannula is a thin, flexible tube with a small opening that provides an avenue for the delivery of fillers into the face. It can be done easily and with ease because of the malleability of the needle.

“I am glad that the U.S. FDA has approved the use of cannula to deliver Restylane Lyft for mid-face augmentation. I have always preferred to use cannula to deliver fillers especially in sensitive, hard-to-reach areas,” said Dr. Siew Tuck Wah, one of the leading aesthetic doctors in Singapore.

Dr. Siew Tuck Wah, Medical Director of Radium Medical Aesthetics

“Normal needles can cause trauma to the skin very easily. In the hands of an inexperienced injector, normal needles may have less flexibility to administer fillers in hard-to-reach places. Using a cannula is much more precise. In addition, using a cannula is also associated with less damage to the surrounding tissue and blood vessels. This translates to less bruising, and less swelling for the patient,” he added.

Dermal filler treatment

Alisa Lask, General Manager and Vice President of the U.S. Aesthetic Business at Galderma was quoted that the FDA approval of Restylane Lfyt for mid-face via cannula ‘marks the seventh FDA approval in aesthetics for Galderma in the past four years’. 

“Our goal is to continue to offer new solutions and delivery systems to our customers to help drive new patients in to aesthetic offices,” she said.

The approval of this cannula indication for the mid-face is the second approval, other than Restylane Silk for lip augmentation, on the market that is FDA-approved for use via cannula. 

What did the study show?

The study was conducted to assess the safety and efficacy profile of Restylane Lyft for cheek augmentation and the correction of age-related mid-face contour deficiencies in conjunction with the use of a small blunt tip cannula. 

The study spanned 16 weeks with 60 male and female subjects 22 years of age and older. 16 weeks after the treatment, 98.3% of the subjects showed improvement in the mid-face based on the assessment using the Global Aesthetic Improvement Scale (GAIS).

There were no reported adverse events that arose from the study. Most of the reported symptoms following the treatment were tolerable and were resolved within 7 days.

Radium Medical Aesthetics is a medical aesthetic clinic in Singapore that offers a wide range of dermal filler treatments including using Restylane Lyft to address signs of aging on the face. Dr. Siew is the appointed regional trainer for Restylane dermal fillers in Asia-Pacific, imparting filler injection techniques to other doctors.