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FDA approves HA filler for midface via cannula injection

Article-FDA approves HA filler for midface via cannula injection

woman injection in cheek

Galderma Laboratories announced in November 2018 that the FDA approved its hyaluronic acid dermal filler Restylane Lyft for correction of age-related midface deformities and cheek augmentation via a small blunt tip cannula.

One of the biggest debates in aesthetic medicine today is whether dermal fillers are best injected using cannulas or needles, according to Manhattan-based dermatologist Anne Chapas, M.D. Dr. Chapas was an investigator for the Galderma midface cannula study, which led to the FDA’s most recent approval for Restylane Lyft.

“I think the study starts to give more data that the cannula in certain areas, especially in the midface in our study, seems to result in treatment where the patients experience less bruising, less pain and still get the same results that they were getting with needle injections,” Dr. Chapas says.

Dr. Chapas and colleagues conducted a 16-week multicenter prospective study of 60 male and female subjects, 22 years of age or older.

“At 16 weeks after treatment, 98.3% of subjects showed improvement in both the right and left midface based on the treating investigator's assessment using the Global Aesthetic Improvement Scale (GAIS), a global 7-point scale for aesthetic improvement in appearance,” according to a Galderma press release. “Following treatment, no severe related adverse events were observed. The majority of reported subject diary symptoms after initial treatment were tolerable (88.3%) and resolved within 7 days.”

Dr. Chapas said that none of the subjects in this study experienced arterial occlusion, as did none of more than 100 subjects in Restylane Lyft needle injection studies. There was a difference, however, between cannula and needle use — favoring the cannula — when it came to post-injection bruising, pain and swelling, she says.

Aesthetic results in both the cannula and needle studies were comparable, according to Dr. Chapas.

“What I like about the cannula injections is that there is usually just one entry point or maybe two entry points compared to multiple different entry points that you sometimes need for a needle,” she says. “I find the cannula works great in the medial and lateral midface. I also use cannulas around the mouth, which is often prone to bruising.”

Dr. Chapas says she doesn’t use cannula injections for the tear troughs because those usually are deep, small aliquot depot injections.

“When I’m doing depot injections, I usually find that I need just a straight needle, but when I’m doing pan volumization, I find the cannula is useful in that I can reach lots of areas with one small insertion point,” she says.

Restylane Lyft has three FDA-approved indications: the midface/cheek, nasolabial folds and back of the hands. Studies suggest it lasts in the midface area for up to a year.