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

AUDIENCE: Patient, Plastic Surgery, Dermatology, Surgery

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.

BACKGROUND: Silicone oil is a liquid polymer of siloxane that can be used in products such as lubricants and caulking materials. FDA has not approved injectable silicone (silicone oil) for large-scale body contouring or enhancement. Injectable silicone is different from silicone oil used in small amounts in the eyes and from the silicone used to fill FDA-approved breast implants. The only FDA-approved injectable silicone is silicone oil used for specific intraocular ophthalmic (inside the eye) use.

RECOMMENDATION: The FDA recommends that you do not inject silicone to achieve breast, muscle, or buttocks enhancement.

Healthcare Providers:

Be aware that:
- The use of silicone oil outside intraocular ophthalmic use is not approved by the FDA.
- Silicone injections used for body enhancement have resulted in serious injuries or death.
- When treating patients after injections for body contouring, the type of material used may be unknown.
- When treating patients who have received silicone injections, the material injected may migrate during revision surgery, which may worsen adverse events and make attempts to remove the injectable silicone oil difficult, incomplete, or impossible.
Educate health care facility staff on how to quickly identify and assist patients who report signs and symptoms of complications from injectable silicone. Staff must understand how to instruct patients to receive appropriate medical care if a serious adverse reaction occurs such as difficulty breathing or signs of a stroke (including sudden difficulty speaking, numbness or weakness in the face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion) during or shortly after a procedure.
Discuss the benefits and risks of FDA-approved options for body contouring with patients.

Recommendations for Consumers: Injectable Silicone

Do not get injectable silicone or any type of filler material for large-scale body contouring or enhancement. This means you should never get an injectable filler as a breast filler, “butt filler,” or filler for spaces between your muscles. The FDA is aware of serious medical problems and multiple deaths associated with such use. (See the Summary of Problem and Scope section above for more information.)
Know that there are no FDA-approved injectable silicone products for body contouring, or to increase the size of areas such as the breasts or buttocks. The only approved uses for dermal fillers are available on the FDA Dermal Fillers website.
Seek medical attention immediately if you experience problems such as difficulty breathing, chest pain, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion) after receiving injectable silicone, as it may be a life-threatening situation. Be sure to let your health care provider know you have had silicone injections.
Seek appropriate medical care, such as from a licensed board-certified plastic surgeon, if you have had silicone oil injections and are experiencing side effects such as pain, hardening of the skin, lumps, or infections.
If you believe you have been offered or have received injectable silicone for body contouring from an unlicensed provider, you are encouraged to use the FDA website to report suspected criminal activity.
If you are considering a body enhancement or body contouring procedure, only see a licensed health care provider who has appropriate training and experience (e.g., plastic surgeon).

Recommendations for Consumers: FDA-Approved Dermal Fillers

Before deciding to have any sort of filler injections, talk with your licensed health care provider about appropriate treatment injection sites and the risks associated with the procedure as well as the product being injected. Know that FDA-approved dermal fillers are not indicated for everyone.
Only get FDA-approved dermal fillers injected by licensed health care providers. These health care providers should have appropriate training and experience and should be knowledgeable about the anatomy at and around the injection site.
When getting any sort of injectable filler, ask your health care provider for the FDA-approved product brochure and patient labeling. ◦Ask questions and read and discuss the patient labeling for the specific filler you are receiving.
- Check the FDA website on approved dermal fillers prior to receiving treatment to confirm that the product has been approved by the FDA.
- Confirm the credentials of your health care provider and the material being injected, and avoid receiving treatment outside of a medical clinic.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch Safety Alert, including a link to the FDA Safety Communication, at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm584986.htm