NOV 22, 2017 2:49 PM PST

FDA Cautions Against Injectable Silicone Use

WRITTEN BY: Carmen Leitch

In recent years there have been a number of arrests related to the unlicensed application of silicone to various parts of people’s bodies. Many people have experienced adverse medical events after receiving silicone injections; their symptoms are irreversible. The U.S. Food and Drug Administration has now issued a warning to consumers; they want people to avoid injectable silicone or products sold as dermal fillers for the enhancement of the body. Use of these products can cause severe injuries and disfigurement.

“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. 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 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, which can include irreversible disfigurement and even death. While we’ll continue to go after those who provide these unlawful services, the FDA will have its greatest impact by educating Americans to avoid these unsafe practices.”

The injectable silicone used for body contouring is not approved by the FDA; it’s different from silicone used in approved breast implants. The FDA has not approved injectable silicone except in one very specific instance inside the eye; they have not approved it for any kind of body contouring. When silicone is injected in an attempt to change the curves of the body, it stays in the body forever and can lead to death. Reactions range from mild scarring to tissue death and disfigurement. The silicone can migrate away from the site of injection and can then block blood vessels. That can lead to a stroke or infections. Complications from silicone injections can develop rapidly, or over years.

The FDA has not approved any silicone injections for body contouring. / Image credit: Maxpixel

“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 someone who has gotten these injections has trouble breathing or speaking, numbness, weakness or difficulty walking or confusion, they are encouraged to see medical attention immediately. The FDA suggests that anyone considering such a procedure speak with a doctor first about the risks. The FDA has a checklist for consumers to review which helps with the selection of products of providers for cosmetic enhancement, Check Before You Inject.


Source: FDA

About the Author
  • Experienced research scientist and technical expert with authorships on over 30 peer-reviewed publications, traveler to over 70 countries, published photographer and internationally-exhibited painter, volunteer trained in disaster-response, CPR and DV counseling.
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