Aesthetic Dermatology

FDA issues alert on illegal silicone injections


The Food and Drug Administration has issued a warning regarding the use of injectable silicone or other products illegally marketed as dermal fillers for body contouring.

“We have significant concerns with unsafe injectable silicone that’s being marketed for body contouring by unlicensed providers,” FDA Commissioner Scott Gottlieb, MD, said in a statement on Nov. 14. “We’ve seen serious adverse events result from products, which are sometimes industrial-grade silicone, being used for these unapproved medical purposes,” he said.

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The FDA’s safety warning points out that injectable silicone differs from the silicone in FDA-approved breast implants, which remains contained within the shell of the implant to avoid migration through the body.

Simply injecting silicone into various parts of the body for contouring purposes is not approved by the FDA. Side effects of such a procedure can occur immediately, or may appear after days, weeks, months, or years, according to the statement. Side effects include pain, scarring, disfigurement, life-threatening embolism, stroke, or infection, the FDA emphasized.

The FDA continues to take action against unlicensed practitioners found guilty of treating patients with unapproved silicone for body contouring. “In addition to prosecuting the criminals who take advantage of consumers, the FDA is taking action to educate consumers in order to prevent the serious injuries resulting from these injections,” Melinda Plaisier, associate commissioner for regulatory affairs at the FDA, said in the statement. “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,” she said.

The FDA will continue to monitor adverse event reports related to silicone, and encourages clinicians or consumers with information about the use of injectable silicone by unlicensed providers to use the “Report Suspected Criminal Activity” form on the FDA website to report those cases.

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