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The FDA Warns Against Injectable Silicone and Dermal Fillers for Large-Scale Body Contouring and Enhancement

Silhouettes of a man and woman to the left and right of a red circle and line crossing out the image of a syringe and the word silicone


Are you considering a procedure to shape or increase the size of certain parts of your body? Beware of using injectable silicone for body contouring or any other unapproved products to achieve your goals. Injectable silicone is not approved by the U.S. Food and Drug Administration for any aesthetic procedure including facial and body contouring or enhancement. Silicone injections can lead to long-term pain, infections, and serious injuries, such as scarring and permanent disfigurement, embolism (blockage of a blood vessel), stroke, and death.

Injectable silicone is not an injectable dermal filler. Injectable dermal fillers are medical devices regulated by the FDA. Most FDA-approved dermal fillers are temporary because they are made from materials that the body eventually breaks down and absorbs. Silicone is NOT one of those materials.

The FDA has approved certain injectable dermal fillers for use in the face (for example, to enhance lips, cheeks, and contouring of the jawline,) and the back of the hand. But no dermal fillers are FDA-approved for large-scale body contouring or body enhancement.

The FDA cautions you to never get injectable silicone or an injectable filler as a breast filler, buttocks (butt) filler, or filler for spaces between your muscles.

Safety Tips

Please consider the following advice.

  1. NEVER get any type of filler or liquid silicone injected for body contouring or enhancement. This means you should never get breast fillers, “butt fillers,” or fillers for spaces between your muscles. These products, which include certain types of injectable silicone, can be dangerous and can cause serious injury and even death.
  2. NEVER buy dermal fillers on the Internet. They may be fake, contaminated, or harmful.
  3. NEVER get injectable fillers from unlicensed providers or in non-medical settings like hotels or private homes.
  4. ALWAYS work with a licensed health care provider who uses FDA-approved products for treatments. Vials should be properly labeled and sealed. If your health care provider offers a procedure using a dermal filler that is much cheaper than similar procedures using FDA-approved dermal fillers or if a product has labeling that looks strange or different than usual, beware.

More About the Dangers of Injectable Silicone

Injectable silicone is permanent and stays in your body. It can move throughout the body and cause serious health consequences, including death. In fact, when injected into areas with many blood vessels, such as the buttocks (butt), silicone can travel through those vessels to other parts of the body and block blood vessels in the lungs, heart, or brain. This can cause a stroke or even death. Large-scale injectable silicone for body contouring and enhancement can also result in a painful and hard, gravel-like substance that stays permanently beneath the skin.

Side effects can occur even years after injecting silicone in your body. Multiple costly medical and surgical interventions are sometimes needed to treat complications years after initial injection. Even then, patients may continue to have serious side effects that require ongoing treatment.

In addition, the FDA is aware of and concerned about the use of counterfeit and fraudulent versions of dermal fillers that have not been FDA-reviewed or approved for any purpose. To learn more about FDA-approved dermal fillers, please read our page on  “Filling in Wrinkles Safely.” You can also find additional information for patients, including more details on FDA recommendations, on the agency's dermal fillers webpage.

Reporting Problems to the FDA

If you experienced problems with silicone injections or dermal fillers, the FDA encourages you to report the problem through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.

The FDA monitors reports of complaints about injectable silicone and other unapproved products. If you’d like to report suspected criminal activity related to FDA-regulated products or the use of  injectable silicone for body contouring or enhancement, you can make a report on the FDA’s website.

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