WASHINGTON—Injectable silicone for body contouring is illegal and can result in serious injury and disfigurement, according to a new safety warning from the U.S. Food and Drug Administration.
The FDA said it wanted to warn consumers and health care practitioners that injectable silicone products are being falsely marketed as FDA-approved dermal fillers for the purpose of enhancing breasts, buttocks and other body parts.
"We have significant concerns with unsafe injectable silicone that's being marketed for body contouring by unlicensed providers," said FDA Commissioner Scott Gottlieb in the Nov. 14 safety communication.
"We've seen serious adverse events result from products, which are sometimes industrial-grade silicone, being used for these unapproved medical purposes," Gottlieb said.
Implantable silicone is different from the silicone contained within FDA-approved breast implants, the agency said. The breast implant shell prevents the silicone from migrating within the body, it said.
Currently, the FDA approves injectable silicone only for intraocular ophthalmic use, according to the safety communication.
"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," the agency said.
Unlicensed or non-medical practitioners often perform silicone injection procedures, which can lead to scarring, tissue death and permanent disfigurement, according to the FDA.
If the silicone migrates, it can cause embolism, stroke or infections, all of which could be fatal, it said.
"Serious complications may occur right away or could develop weeks, months or years later," the agency said.
The FDA encourages those who have received or been offered injectable silicone treatments to report the illegal service providers.