About 1.5 million procedures using facial fillers were done in 2007 and although fillers are safe when used correctly, new FDA data says they have been getting some reports of some serious problems.
Nineteen different patients ended up in the emergency room after allergic reactions, 12-developed infections that required hospitalization, and others reported serious reactions including facial, lip and eye paralysis, and vision trouble.
The FDA says that as these procedures become more popular, so does the problem of untrained people offering them. Plastic surgeon Dennis Bucko, M.D., says, "A lot of the problems they've had with adverse events have been because people who have not been trained to do these procedures are doing the injections".
FDA experts agree with Dr. Bucko and that is why they are raising questions about unapproved or "off label" uses. Now, the FDA is considering product label changes, possibly with some restrictions on where the fillers may be injected.