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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
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
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,
“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 Link...