INDUSTRY INSIDER | RESTYLANE SILK |
RESTYLANE SILK SETS A NEW STANDARD FOR
ENHANCEMENT W
LIP
Wendy Lewis reports on Galderma’s launch of Restylane® Silk in the US, the first filler to gain the coveted lip indication from the FDA
HILE MUCH OF THE COUNTRY was experiencing an arctic freeze, a large group of dermatologists, plastic surgeons, facial plastic surgeons, and nurses made their way to Galderma’s US hometown
WENDY LEWIS is President of Wendy Lewis & Co Ltd, Global Aesthetics Consultancy, author of 11 books, and Founder/ Editor-in-Chief of www.
beautyinthebag.com. She is a contributor to a number of trade and consumer publications in the USA and Europe.
contact
wl@wlbeauty.com
of Dallas, Texas to get hands on experience with the newest filler of 2015. The company held a training session in January to educate and train healthcare providers on Restylane® Silk to ensure the safe and effective use of the product as they ramp up for launch. Of particular interest, the program provided an overview of the aging lip and perioral area, and of the anatomy and proper assessment of the lip and perioral area. On June 16, 2014, the US FDA gave its nod to Restylane®
Silk Injectable Gel with 0.3% lidocaine, with an indication for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytides1
. At
that time, Restylane® and Perlane® products were part of the Valeant Pharmaceuticals Inc. empire, having previously purchased Medicis Pharmaceuticals in 2013. Subsequently, in July 2014, Valeant completed the sale to Galderma of all rights to Restylane and Perlane, along with Emervel, Sculptra, and Dysport to Nestle S.A, which had earlier acquired Galderma. The Restylane family of products includes Restylane®,
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Restylane-L®, Restylane® Silk, Perlane®, and Perlane-L®. Restylane, Restylane-L, Perlane, and Perlane-L can be used to add volume and fullness to the skin to correct moderate to severe facial wrinkles and folds. Restylane, Restylane-L and Restylane Silk may also be used for lip enhancement in patients over 21 years, and Restylane Silk can be used to treat lip lines in patients over 21 years2
. January/February 2015 |
prime-journal.com ‘We are very proud to introduce Restylane Silk — the first
and only FDA approved treatment for natural lip enhancement and the smoothing of wrinkles around the mouth — to US healthcare professionals and consumers,’ said Stuart Raetzman, CEO of Galderma Laboratories, L.P. and Vice President North America. ‘Restylane Silk satisfies the market need for a subtle solution that addresses the signs of aging in the lip and mouth area and we are pleased to be able to provide this new and unique offering to the US aesthetics market.’ Restylane® Silk is a crystal clear injectable gel composed
of hyaluronic acid, that is non-animal based and free from animal protein, therefore no allergy pretesting is required. It also contains 0.3% lidocaine to reduce the discomfort for patients, which is especially beneficial in the perioral region that is known to be more sensitive in some patients. The clinical study conducted with Restylane® Silk to
evaluate the safety and effectiveness of injections to enhance lip fullness and to improve the wrinkles around the lips. The study included 221 mostly female subjects and evaluated subjects with light and dark skin. Subjects with very dark skin were not studied. Ninety-eight percent (98%) of subjects reported improvement in their lip fullness 14 days after injection and a compelling 76% of study subjects still had lip improvement 6 months after injection. Adverse events reported included mild swelling, bruising, and discomfort.
Rich history of Restylane Restylane has an impressive track record as a dermal filler globally. Originally launched in 1996 by Q-Med (Uppsala, Sweden) after receiving a CE Mark, it has two decades of research behind the brand, and a well-documented safety
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