The FDA Warns Against Injectable Silicone for Body Contouring and Enhancement
Silicone injections to enlarge breasts, buttocks and other parts of the body are illegal and could cause life-threatening medical complications for patients, days or even decades after receiving them, federal regulators said Tuesday in a new warning for consumers considering cosmetic procedures.
Consumers are increasingly seeking silicone injections for body shaping, raising alarms at the Food and Drug Administration about the potential danger to their health, said Dr. Jacqui Francis, a physician consultant for the federal regulatory agency.
“They can cause you problems,” Francis said. “Everyone should know that it’s illegal.”
Injectable silicone is an oily substance commonly used in lubricants and caulking, and it’s different from the silicone used in encased breast implants.
But it’s the use of large amounts of silicone to plump up body parts — anything greater than a teaspoon, Francis said — that worries federal regulators most. They’ve launched a public awareness campaign using the hashtag #CheckBeforeYouInject.
Silicone can cause potentially fatal clots, and it can harden, causing chronic inflammation and infections. Silicone can even ooze through the skin as the substance mixes with body tissue.
“Liquid silicone isn’t encased, like it is in a breast implant,” Francis said. “It can flow freely through the body and can cause problems at any time. We don’t know why. We don’t know when. There have been reports of patients having complications 40 years after receiving injections.”
There is no official data on the illicit practice of injecting silicone oil for body shaping. But the dangers of the procedure gained national attention in 2013 when a popular Miami Spanish-language radio personality, Betty Pino, died of complications from surgery to remove the substance from her buttocks.
It is unknown where Pino received the silicone injections. But a series of high-profile criminal cases in South Florida have shed light on those who profit — and those who are injured — by the practice.
In October, a disgraced Miami doctor was sentenced to four years in prison for practicing without a license, and ordered to pay $145,000 in restitution to a former patient he had injected with silicone at the now-defunct Bella Beauty Spa, where hundreds of women had received the procedure, according to Miami-Dade court records.
The spa’s owner was sentenced to six years in federal prison in August for using liquid silicone smuggled from Colombia for the illicit injections provided at the West Flagler Street clinic.
And in April, a Miami-Dade judge ordered the disgraced doctor and the spa owner to pay $818,000 in damages to a former patient of Bella Beauty who suffered permanent injuries as a result of a botched Brazilian butt lift surgery.
The FDA’s Francis said consumers should beware of any claims that a silicone injection is FDA-approved. The agency approves certain dermal fillers, such as Juvederm or Restylane, that smooth wrinkles with small amounts of collagen and other substances.
But large amounts of silicone injected into the body for breast or buttocks enhancement or for smoothing muscles remains illegal. Consumers can report clinics and providers that use silicone injections by contacting the FDA online at fda.gov.