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Are Silicone Injections Legal?

By Stephanie Rabiner, Esq. on January 10, 2012 5:57 AM

Silicone injections have been getting a bad rap as of late. There was the man who died after receiving a penis injection. And then there was the group of women whose botched butt injections required hospitalization.

There's no doubt that silicone injections can lead to complications. But amongst all of this talk, there is one question that has yet to be answered:

Are silicone injections legal?

Silicone injections are not legal when administered by someone who is not a licensed medical professional. Besides being illegal, these injections often don't contain medical-grade silicone. It's best to avoid "pumping parties" and hotel room deals.

When administered by a licensed physician, silicone injections are legal. However, they are not currently approved by the Food and Drug Administration.

The FDA rescinded approval of cosmetic silicone injections in 1992. But in 1994, it approved a series of silicone oils for use in the treatment of retinal detachments and other complications.

Silicone oil is thus defined as a "legally marketed medical device."

Medical professionals may administer any approved "legally marketed medical device" per the terms of the Federal Food, Drug, and Cosmetic Act. They can even prescribe or administer that device for off-label uses.

They can thus legally prescribe and administer silicone for cosmetic purposes.

Though silicone injections are legal, they are still dangerous. The FDA rescinded approval after women complained of deformity and respiratory problems. The liquid has also entered the bloodstream, leading to a number of deaths. So if you decide to get them, be aware of the risks.

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