The United States Food and Drug Administration (FDA) is alerting the public and health care providers that injectable silicone is not approved to enhance or augment the body. Such use can lead to ongoing pain, infections, and serious injuries, such as scarring and permanent disfigurement, embolism (blockage of a blood vessel), stroke, and death.
According to the FDA, silicone oil is a liquid polymer of siloxane that can be used in products such as lubricants and caulking materials. FDA has not approved injectable silicone (silicone oil) for large-scale body contouring or enhancement. Injectable silicone is different from silicone oil used in small amounts in the eyes and from the silicone used to fill FDA-approved breast implants. The only FDA-approved injectable silicone is silicone oil used for specific intraocular ophthalmic (inside the eye) use.
The FDA is aware of cases where patients have received injectable silicone for body contouring purposes, such as gluteal or breast enhancement ("butt fillers" or "breast fillers"), by unqualified providers posing as doctors or licensed healthcare practitioners in non-clinical settings such as residential homes or hotels. The FDA is aware that some injectors have falsely told consumers they were receiving an FDA-approved dermal filler, but consumers were instead injected with silicone.
Injectable silicone is permanent, with side effects that can occur right after the injection and up to years after treatment. Silicone spreads and migrates easily inside the body, which may worsen adverse events and make surgical attempts to remove the silicone oil more difficult or impossible. Silicone, when injected into areas with many blood vessels such as the buttocks, can travel to other parts of the body and block blood vessels in the lungs, heart, or brain. This can result in permanent damage to those tissues and lead to stroke or death.
Surgery to remove large-scale injectable silicone may present additional risks and serious complications, and may not entirely rid the body of the silicone. Multiple medical and surgical interventions are sometimes needed to treat symptoms years after initial injection; even then, patients may continue to experience ongoing pain, infection, and scarring and permanent disfigurement requiring ongoing treatment.
The FDA is monitoring reports of adverse events associated with the use of injectable silicone and other unapproved materials and will update the public if significant new information becomes available.
For details, please refer to the FDA websites:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm584986.htm
https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm584824.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 November 2017