FDA Issues Warning Regarding Illegal use of Injectable Silicone for Body Contouring

FDA warns about illegal use of injectable silicone for body contouring and associated health risks

The U.S. Food and Drug Administration has issued a safety communication to warn consumers and health care practitioners about the serious injuries and disfigurement that can result from using injectable silicone or products being falsely marketed as FDA-approved dermal fillers for the purpose of enhancing the size of their buttocks, breasts and other body parts.

"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. 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," said FDA Commissioner Scott Gottlieb, M.D. "The FDA has stepped in to take enforcement actions against unscrupulous actors who promote and provide these services, but we also want to make the public aware of the risks, which can include irreversible disfigurement and even death. While we'll continue to go after those who provide these unlawful services, the FDA will have its greatest impact by educating Americans to avoid these unsafe practices." Click here to continue reading press release...

Additional Resources

• FDA Press Release [ Spanish]

• FDA Consumer Update [ Spanish]
  
• FDA Safety Communication [ Spanish]

• FDA Check Before You Inject Checklist