Restylane is an injectable filler used to treat wrinkles. Restylane is made of hyaluronic acid, a non-animal product that is naturally produced in the body. Restylane can be used instead of collagen on people who are allergic to it or who prefer using non-animal products. When injected, Restylane plumps up wrinkles, causing them to fill out and become smooth and basically invisible.
What's Approved
Restylane was approved by the FDA on December 12, 2003. The approval was for its use as an agent to smooth out wrinkles and folds on the face, particularly the nasolabial folds. Nasiolabial folds are the lines that form on the side of the mouth, down from the nose and towards the chin.
What's Not Approved
Although the FDA has only approved Restylane as a wrinkle filler, doctors use it for other purposes as well. This is known as off-label use. Common off-label applications of Restylane include lip augmentation, wrinkles around the mouth, plumping of scars and lines on the hands, and to enhance the cheekbones. The FDA has not granted approval for these uses, and it’s likely it never will. Once a product has been approved for a specific cosmetic issue, it’s common practice for plastic surgeons and dermatologists to use it in the treatment of related issues.
