The Food and Drug Administration (FDA) has released a safety alert to warn about serious injuries and disfigurement that may occur with the use of injectable silicone or products falsely marketed as FDA-approved dermal fillers for enhancement of buttocks, breasts, and other body parts. 

The unsafe injectable silicone is being marketed for body contouring uses by unlicensed providers in non-clinical settings (eg, homes, hotels); industrial-grade silicone, which is sometimes used for these unapproved purposes, can cause irreversible disfigurement and even death. Recently, two spa owners were arrested in Miami and sentenced to prison for managing a spa that performed illegal silicone injections. 

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Adverse effects related to the use of these unapproved products include ongoing pain, scarring, tissue death, and permanent disfigurement. Moreover, if the silicone travels past the injection site, embolism, stroke, infections, and even death can occur. 

The FDA has issued the following recommendations for healthcare professionals:

  • Be aware that injectable silicone is not approved for large-scale body contouring or enhancement; silicone should not be injected to achieve breast, muscle, or buttocks enhancement
  • Be aware that the use of silicone oil outside intraocular ophthalmic use is not approved by the FDA
  • Silicone injections used for body enhancement have resulted in serious injuries or death
  • When treating patients after injections for body contouring, the type of material used may be unknown
  • When treating patients who have received silicone injections, the material injected may migrate during revision surgery, which may worsen adverse events and make attempts to remove the injectable silicone oil difficult, incomplete, or impossible
  • Educate healthcare facility staff on how to quickly identify and assist patients who report signs and symptoms of complication from injectable silicone
  • Discuss the benefits and risks of FDA-approved options for body contouring with patients
  • Report to the FDA if you become aware of a patient experiencing an adverse event associated with injectable silicone

Associate commissioner for regulatory affairs at the FDA, Melinda Plaisier, stated, “With our communication today, we hope to raise public awareness about the short- and long-term risks of injecting silicone directly into the body, and encourage consumers to choose FDA-approved products and licensed providers when considering any type of cosmetic enhancement.”

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