Injectable Silicone for Body Contouring and Enhancement: FDA Safety Communication - FDA Warns Against Use

From Drugs.com - November 14, 2017

Injectable Silicone for Body Contouring and Enhancement: FDA Safety Communication - FDA Warns Against Use

Audience: Patient, Plastic Surgery, Dermatology, Surgery

[Posted 11/14/2017]

ISSUE: The 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.

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.

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