The U.S. Food and Drug Administration is alerting the public and health care providers 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.
Injectable silicone is different from the approved silicone contained within breast or other implants, and 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.
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, 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. For those who are considering a body contouring procedure, talk with a health care provider about appropriate treatment options and the risks associated with the procedure.
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