The U.S. Food and Drug Administration (FDA) has the authority to approve and regulate facial implants, as well as a variety of medical devices, equipment and pharmaceuticals. The FDA grants specific “approved for use” status. Approval is granted only for the “use” presented in the research. Companies must submit documentation in the form of research studies, before the FDA will consider approval. 


Implant and Procedure Approval

Implants fall into a special category of approval. Implants are placed in the tissue of the body; therefore, both the implant material and the procedure must be approved. The procedure is regulated, because tissue either surrounds or integrates with the implant. The FDA requires research on the effects of implants to surrounding tissue. 


Synthetic Porous Implants

  • polyethylene allows tissue to rebuild within and around the implant
  • titanium mesh allows tissue integration within the mesh frame 

Biologic Implants

According to FDA regulations, implants designed to regenerate tissue growth fall into the category of tissue transplants. This includes bone, cartilage and tissue harvested from the patient to be used in another region of the body. 


Derma Fillers

Although derma fillers are not permanent, they fall under the FDA definition and regulation of implants.

FDA approval does not prevent your physician from using devices for non-approved methods or treatments.