Last week we talked about chin implants. This week we're piggybacking on that and discussing prosthetic faces. These devices are Class I (lowest risk) if external and not implanted. Think about a rubber nose, but for more noble purposes than a Halloween costume.
More specifically, FDA's CFR (Code of Federal Regulations Title 21) refers these prosthetic devices as "external aesthetic restoration prosthesis" and defines them as "a device intended to be used to construct and external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with an external prosthesis adhesive. The device is not intended to be implanted." Because of their low risk, these devices are exempt from premarket notification procedures.
The case in the video below shows well why these prosthetics are important. Prior to getting her prosthesis, Chrissy Steltz, who lost her eyes, nose, and the supporting structures in her mid-face due to a gunshot wound, went out in public wearing an oversized sleeping mask to hide her injuries. Though Steltz's insurance refused to cover the procedure because they deemed it "aesthetic", her doctors worked for free to help her through the procedure and reclaim some normal quality of life.
Note that the dental implants with magnets that are used to fasten the device may be an off-label use, but keep in mind that FDA does not regulate the practice of medicine.
The video states that making the prosthetic is part art, and part science, and for me this is what really drove home the humanity in these devices and why they are important. These doctors, working for free, put so much care into getting the look in the eyes just right, and baking Chrissy's favorite makeup look right into the device so that she won't have to apply makeup or touch it up. Perhaps, then, it is no surprise that Chrissy states her greatest wishes are for her son to grow up with a mother who is "more in a regular world, where he can look at mom and see she is as regular as everybody else" and to "be looked at like a plain Jane. Like everyone else".