FDA Warns Against Injectable Silicone

The FDA recently issued a warning to caution against the dangers of injectable silicone for cosmetic enhancement. Although silicone breast implants and other similar medical devices are FDA-approved to be placed inside the body for cosmetic use, it is dangerous to have the substance directly injected. According to the FDA warning, silicone can cause several health risks if injected, such as permanent disfigurement, tissue damage, ongoing pain, stroke, and death.

In some cases, patients have unknowingly been injected with silicone—these patients were led to believe they were receiving an FDA-approved dermal filler, such as JUVÉDERM®. The individuals performing these unsafe procedures falsely presented themselves to their patients as doctors or other healthcare professionals, and conducted the treatments in non-clinical settings (such as hotel rooms or homes).

Once injected, silicone is permanent and can travel throughout the body easily. It can quickly become problematic, as it may block blood vessels, resulting in an embolism that may lead to stroke or death.

To ensure patient safety (as well as ideal outcomes), Dr. Thomas Lintner strongly urges that you thoroughly research the healthcare provider you are considering for your cosmetic injections. Qualified practitioners include most board-certified plastic surgeons and registered nurse injectors. If you are unsure, the official product website for the cosmetic injectable you are considering should have an option to help you find a healthcare professional in your area who is licensed and trained to safely administer the product.

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