The U.S. Food and Drug Administration is warning consumers about the dangerous and illegal use of injectable silicone for breast and buttocks enhancements.
"The FDA is alarmed by the increasing trend of injectable silicone being used for body contouring purposes," Melinda Plaisier, associate commissioner for regulatory affairs at the FDA, said in a statement Tuesday. ""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."
Injectable silicone is different from the silicone in approved breast implants, since the breast implant shell keeps the silicone from migrating within the body, FDA officials said. Injectable silicone is currently only approved by the FDA for a specific use inside the eye.
Nevertheless, some consumers are falsely told they are receiving an FDA-approved injection when they're actually getting silicone, FDA officials said.
"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 says injectable silicone used for body contouring is not FDA-approved and can cause serious side effects that may be permanent or may even lead to death. Side effects can include ongoing pain and serious injuries, such as scarring, tissue death, and permanent disfigurement. And if the silicone migrates beyond the injection site, it could cause an embolism (blockage of a blood vessel), stroke, infections and death.
South Florida has seen several cases where buttocks injections and other procedures have been performed by unlicensed practitioners. Two Miami spa owners were arrested in February and recently sentenced to four and six years in prison for managing a spa that performed illegal silicone injections, FDA officials said. Hundreds of clients received illegal buttock injections and many experienced irreversible injuries and symptoms as a result of the silicone migrating through their body.
"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," Gottlieb said.
Consumers are encouraged to review the FDA's Check Before You Inject checklist for helpful information on choosing FDA-approved products and licensed providers for cosmetic enhancement.