FDA is cracking down on illegal products intended to boost the size of a person's breasts, butt, or other body parts.
“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, MD. “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."
Gottlieb said the agency will continue to go after providers of these unlawful services, but he said public education will be where FDA has its greatest impact on this problem.
Injectable silicone is different from the silicone contained within approved breast implants, FDA said, because the breast implant shell keeps the silicone from migrating within the body. Injectable silicone is currently only approved by FDA for intraocular ophthalmic use.
When seeking breast, buttocks, 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. Side effects of these illegal procedures include pain, scarring, tissue death, and permanent disfigurement. If the silicone migrates beyond the injection site, it could cause an embolism, stroke, infection, or death. Serious complications may occur right away or could develop weeks, months, or even years later, the agency noted.
Silicone injections for body contouring are often performed by unlicensed and non-medical practitioners in non-clinical settings such as residential homes or hotels. 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 agency.
“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 FDA. “The agency has investigated and prosecuted unlicensed providers administering these injections all over the country, including most recently in Miami."
The FDA has participated in a number of criminal enforcement actions in recent years that resulted in the arrest and sentencing of unlicensed practitioners who illegally used these unapproved injections on patients. 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. Hundreds of clients received illegal buttock injections and many experienced irreversible injuries and symptoms as a result of the silicone migrating through their body.
For those considering a body contouring procedure, FDA recommends consumers talk to a healthcare provider about appropriate options and the associated risks. The agency also has a Check Before You Inject checklist to help consumers choose FDA-approved products and licensed providers for cosmetic procedures.
Those who have been offered or have received injectable silicone for body contouring from an unlicensed provider are encouraged to use the agency's website to report suspected criminal activity.
Even approved silicone implants carry some risk. Earlier this year a woman sued Johnson & Johnson for pain and illness caused by her leaking silicone breast implant.