On November 14, 2017, the FDA issued a safety communication that 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.
The FDA warned that 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 and may lead to death. The side effects of using injectable silicone for body contouring can include ongoing pain, scarring, tissue death, and permanent disfigurement. If the silicone migrates beyond the injection site, the FDA warned that it could cause an embolism (blockage of a blood vessel), stroke, infections, and death, and that serious complications may occur right away or could develop weeks, months, or years later.
The FDA further warned that 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.
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 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 they are actually injected with silicone.
The FDA cited the cases of two Miami spa owners who were arrested in February 2017 and were 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, 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, the FDA suggests that consumers talk with a health care provider about appropriate treatment options and the risks associated with the procedure.
If you have been injured as a result of injectable silicone used for body enhancement in the United States, you should seek the advice of a medical malpractice attorney in your U.S. state who may investigate your possible medical malpractice claim for you and represent you in a medical malpractice case, if appropriate.
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