With over a dozen injectable fillers on the aesthetic facial market in the U.S, and new ones appearing annually, a news release that another injectable filler product or indication has been approved is not revolutionary. Such is the case today as the Food and Drug Administration has given clearance for Restylane Silk injectable filler manufactured by Valeant pharmaceutical company. Restylane Silk is an injectable hyaluronic acid-based filler that contains 0.3% lidocaine. The uniqueness of this injectable filler product is that it is approved for lip augmentation and the treatment of perioral rhytids (mouth wrinkles) in patients 21 years or older.
In a clinical study that led to its approval, Restylane Silk was studied in over 220 patients for its effectiveness and safety for lip augmentation and direct injection into the dermis of mouth wrinkles. The study results showed that almost 100% had improvement in lip fullness two weeks after the treatments and over 75% had sustained lip fullness improvement six months later. Adverse events reported were very typical including temporary swelling and bruising and pain on injection.
Lip augmentation by injectable fillers has been around long before even the first FDA-approved product (the original Restylane) was initially approved in 2002. They have been used ‘off-label’ for lip and perioral treatments for over twenty years. They have been and will continue to be in high demand for lip enhancement due to their immediate effects and usually good results. (which are highly injector dependent) The major players in the injectable filler market have been slowly getting around to get formal FDA approval for lips and Restylane Silk now fulfills that objective for the Valeant product line. It is now the second injectable filler after Juvederm to get formally approved for lip augmentation.
The key to a good injectable filler for the lips are that it should be hyaluron-based (for assured and uncomplicated resorption), have a viscosity that permits an easy flow through a 30 gauge needle (to lessen the occurrence of lumps and clumps) and it has a lidocaine additive. (to lessen immediate after injection discomfort)
Dr. Barry Eppley
Indianapolis, Indiana