FDA Warns That Unapproved Dermal Filler Treatments Can Cause Serious Harm

The U.S. Food and Drug Administration has stepped up to issue a safety warning to consumers and health care medical professionals about the serious injuries and disfigurement that may result from using injectable silicone or other products being falsely marketed as “FDA-approved dermal fillers” for the purpose of enhancing the size of a persons buttocks, breasts or other body parts.

“An important part of our public health mission is our obligation to warn consumers of unapproved products that are being marketed for medical uses that can cause serious harm,” said FDA Commissioner Scott Gottlieb, M.D. “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.”

While people tend to look for injectables to enhance and contour their bodies, a telltale sign that you’re not in the hands of a true professional is if you yourself in a hotel room with so called doctor.

“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.”

If you’re interested in a body contouring procedure in Virginia, trust the experts at Rostami OPC. Call us today to schedule an appointment in our professional setting located in Reston, Virginia.