Hylaform is a dermal filler made from a kind of avian material. In general, the process for hylaform involves injections of this material, which temporarily fill in a facial area and provide a change in appearance.
Is Hylaform Approved by the FDA?
An internal resource from the U.S. Food and Drug Administration shows that the product was approved for use on the market in April of 2004. The Center for Devices and Radiological Health, a division of the regulatory agency, provides information on the approval of the device in an approval letter that is on file at the FDA web site.
Approval Conditions
Further reading of FDA resources shows that the agency attached some conditions to the approval of the product. For one, Hylaform is not to be sold over the counter, but distributed to professionals who will provide dermal filling procedures. In addition, the FDA required the company producing Hylaform to submit the product to additional studies to show its safety and effectiveness. Hylaform is subject to the same labeling requirements as similar products.
Use of the product has shown that there are some potential side effects for the product, especially in individuals who have avian allergies of any kind. Consult your family doctor and dermatology specialists before scheduling a Hylaform procedure.
