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FDA warns about illegal use of injectable silicone for body contouring and associated health risks (2017-11-17)

The U.S. Food and Drug Administration today issued a safety communication to warn consumers and health care practitioners about the serious injuries and disfigurement that can result from using injectable silicone or products being falsely marketed as FDA-approved dermal fillers for the purpose of enhancing the size of their buttocks, breasts and other body parts.

IInjectable silicone is different from the silicone contained within approved breast implants, because the breast implant shell keeps the silicone from migrating within the body.

Injectable silicone is currently only approved by the FDA for a specific use inside the eye (intraocular ophthalmic use).

When seeking to enlarge the size of their buttocks or breasts, or other large-scale body contouring procedures, some consumers are falsely told they are receiving an FDA-approved dermal filler, but are actually injected with silicone.

Consumers need to be aware that 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; if the silicone migrates beyond the injection site, it could cause an embolism (blockage of a blood vessel), stroke, infections and death.

Serious complications may occur right away or could develop weeks, months, or years later.

Check Before You Inject: 4 Safety Tips

Please consider the following advice.

NEVER get any type of filler or liquid silicone injected for body contouring or enhancement.
This means you should never get breast fillers, “butt” fillers, or fillers for spaces between your muscles.
These products, which include certain types of injectable silicone, can be dangerous and can cause serious injury and even death.

NEVER buy dermal fillers on the Internet. They may be fake, contaminated, or harmful.

NEVER get injectable fillers from unlicensed providers or in non-medical settings like hotels or private homes.

ALWAYS work with a licensed health care provider who uses FDA-approved products for treatments.
Vials should be properly labeled and sealed.
If your health care provider offers a procedure using a dermal filler that is much cheaper than similar procedures using FDA-approved dermal fillers, or if a product has labeling that looks strange or different than usual, beware.

“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.”

Silicone injections for body contouring are often performed by unlicensed and non-medical practitioners in non-clinical settings such as residential homes or hotels.

The FDA does not know the true extent of these injuries caused by these procedures because unlicensed practitioners do not report injuries incurred from their illegal practice and patients who are harmed may not know to alert the FDA.

For more information
U.S. Food and Drug Administration FDA
Comsumer Updates