FDA Warning: Illegal Use of Injectable Silicone for Body Contouring

warningThe FDA has issued a warning to consumers and health care practitioners about serious injuries and disfigurement from using injectable silicone or products being falsely marketed as FDA-approved dermal fillers. 

The illegally marketed injectable silicone is different from silicone contained within approved breast implants—the breast implant keeps the silicone from migrating within the body, the agency said. Currently, injectable silicone is only approved by the FDA for a specific use inside the eye. 

According to the FDA, consumers can experience serious side effects that may be permanent if they receive the injectable silicone. Common side effects that have been reported include, ongoing pain and serious injuries, such as scarring, tissue death, and permanent disfigurement. The FDA notes that if the silicone migrates beyond the injection site, it could cause an embolism, stroke, infections and death. Notably, serious complications may occur right away or could develop weeks, months, or years later.

Often, silicone injections for body contouring are performed by unlicensed and non-medical practitioners so the FDA does not know the true extent of these injuries caused by these procedures.

“The FDA is alarmed by the increasing trend of injectable silicone being used for body contouring purposes,” said Melinda Plaisier, associate commissioner for regulatory affairs at the FDA. “The agency has investigated and prosecuted unlicensed providers administering these injections all over the country, including most recently in Miami. 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. 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.”

Julie Gould