Injectable Silicone For Body Contouring Can Lead To Severe Injuries, Disfigurement, FDA Warns

Federal health regulators are warning about the risk of severe health problems from injectable silicone, which is often used for “body contouring”; which alters the shape of the body for cosmetic reasons. 

The FDA issued a safety communication on November 14, to alert the public and health care providers that the agency has never approved the use of injectable silicone for body augmentation. The alert warns that injecting silicone can have a variety of adverse health effects, including pain, infections, scarring, permanent disfigurement, embolism and death.

The agency notes that officials have become aware that some injectable silicone is being illegally marketed as FDA-approved dermal fillers. These illegal ads claim that it can be used to enhance the size of buttocks, breasts and other parts of the body, according to the agency. The FDA has only approved the use of injectable dermal fillers for the face and hands.

“An important part of our public health mission is our obligation to warn consumers of unapproved products that are being marketed for medical uses that can cause serious harm,” FDA Commissioner Scott Gottlieb said in a press release. “We have significant concerns with unsafe injectable silicone that’s being marketed for body contouring by unlicensed providers. We’ve seen serious adverse events result from products, which are sometimes industrial-grade silicone, being used for these unapproved medical purposes.”

Gottlieb said that the agency has taken enforcement action against a number of sellers of unapproved dermal fillers. The agency also noted that there have been severe injuries and some deaths associated with their use.

The FDA is also aware of fake dermal filler products on the market and is warning both patients and healthcare providers to be aware that there is a risk of receiving counterfeit dermal fillers.

The agency has released a checklist called “Check Before You Inject” (PDF) on how to verify that a dermal filler is approved and being used for an approved purpose.

The FDA advises consumers to:

• Never get an injectable filler, such as silicone, as a butt or breast filler, or as a means to filling spaces between muscles
• Never get injectable fillers from unlicensed healthcare professionals or in nonmedical settings, like a hotel or private home.
• Never buy dermal fillers on the internet.
• Never receive any filler or liquid silicone injections for large-scale body contouring or enhancement.

The agency urges consumers to report any offers or use of injectable silicone from an unlicensed provider to its criminal activity division. It also calls on consumers who have suffered injuries or adverse health effects following the use of a dermal filler to its MedWatch adverse event reporting program.