FDA Issues Warning Against the Use of Injectable Silicone for Body Enhancement

Injection syringe
Injection syringe
Injectable silicone is not approved for body enhancement use and can cause serious complications, including scarring and permanent disfigurement, embolism, stroke, and death.

The FDA has issued a warning against the use of injectable silicone for body contouring and enhancement and has provided recommendations for clinicians on how to approach patients who are considering injectable silicone or are suffering from silicone-related complications.

Injectable silicone can cause infections and serious injuries, such as scarring and permanent disfiguring, embolism, stroke, and death. Silicone can also spread inside the body and make surgical removal difficult or even impossible.

The FDA is aware of patients receiving injectable silicone for body enhancement, particularly in large areas of the body such as the breasts and buttocks, from unqualified individuals posing as doctors in non-clinical settings claiming to give patients FDA-approved dermal fillers. The FDA encourages reporting suspected criminal activity to the FDA MedWatch Safety Information center on their website.

The FDA recommends that clinicians educate their medical staff on how to quickly identify patients who report symptoms of silicone-related complications, particularly signs of stroke. Clinicians are also advised to talk to their patients about the benefits and risks of FDA-approved options for body enhancement, including FDA-approved dermal fillers.

Related Articles


FDA warns about illegal use of injectable silicone for body contouring and associated health risk [press release]. FDA; November 14, 2017. Accessed November 14, 2017.