FDA Aims at Injectable Silicone


Multiple options exist to contour the body in today’s esthetics market—according to a recent safety communication from the U.S. Food and Drug Administration (FDA), injectable silicone should not be one of them.

Injectable (and sometimes industrial-grade) silicone marketed by unlicensed providers and meant to enhance the breasts, buttocks or other body parts were the subject of the warning. These products are often marketed as FDA-approved dermal fillers and, according to the FDA, can lead to irreversible disfigurement or death.

Side effects can include chronic pain, scarring and tissue death, along with embolism, stroke, infections or death if silicone migrates from the injection site. Potential symptoms of silicone injection side effects include difficulty breathing, chest pain and signs of a stroke.

“The FDA is alarmed by the increasing trend of injectable silicone being used for body contouring purposes. … 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,” said Melinda Plaisier, FDA associate commissioner for regulatory affairs.

Practitioners and consumers are encouraged to consult the FDA’s “Check Before You Inject” guide before moving forward with an esthetic injection to ensure that products are safe, and to report suspected illegitimate injectables to the FDA.

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