The FDA is alerting the public and health care providers that injectable silicone is not approved to enhance or augment the body. Such use can lead to ongoing pain, infections, and serious injuries, such as scarring and permanent disfigurement, embolism (blockage of a blood vessel), stroke, and death.

The FDA is aware of cases where patients have received injectable silicone for body contouring purposes, such as gluteal or breast enhancement (“butt fillers” or “breast fillers”), by unqualified providers posing as doctors or licensed healthcare practitioners in non-clinical settings such as residential homes or hotels. The FDA is aware that some injectors have falsely told consumers they were receiving an FDA-approved dermal filler, but consumers were instead injected with silicone.
Read more at the FDA >>