On November 14, 2017, the FDA warned 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.
“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.”
Injectable 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 the 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.
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.
“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.”
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.
The FDA encourages consumers who may have received injectable silicone to seek medical attention immediately if they experience problems such as difficulty breathing, chest pain, or signs of a stroke (including sudden difficulty speaking, numbness or weakness in the face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), as it may be a life-threatening situation. Those considering a body contouring procedure should consult with a health care provider about appropriate treatment options and the risks associated with the procedure. Consumers are encouraged to review the FDA’s Check Before You Inject checklist for helpful information on choosing FDA-approved products and licensed providers for cosmetic enhancement.
Those who have been offered or have received injectable silicone for body contouring from an unlicensed provider are encouraged to use the FDA website to Report Suspected Criminal Activity.
See the FDA Announcement
See also Medical Law Perspectives Report: Cosmetic Surgery Gone Wrong: High Hopes Meet Unexpected Results
See also Medical Law Perspectives Report: Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous Territory
See also Medical Law Perspectives Report: Off-Label Use of Prescriptions: When is this Medical Malpractice? Is the Pharmaceutical Company Liable for Overpromotion?