FDA: ANTI-WRINKLE INJECTIONS CAN CAUSE STROKES, BLINDNESS OR DEATH

By Miriam Raftery

May 30, 2015 (Washington D.C.) – There’s a new wrinkle to consider before signing up for those wrinkle-plumping injections of soft tissue fillers, also called derma fillers or injectible face implants. The substances that have gained popularity with cosmetic surgeons and other healthcare providers to reduce the appearance of wrinkles on the face or to augment lips and cheeks.

But now the U.S. Food and Drug Administration (FDA) has issued a warning that these fillers, if accidentally injected into blood vessels, can block blood vessels and restrict blood supply to tissues, resulting in embolisms that cause serious effects including stroke, blindness, necrosis or death of the skin and underlying facial structures, or even death.  While rare, the consequences can be irreversible.

While unintentional injections into blood vessels may occur with injection sites anywhere on the face, the FDA’s review of literature  and adverse event reports submitted to the FDA show that the  injection locations where blood vessel blockage have been reported more often include the skin between the eyebrows and nose, in and around the nose, forehead, and around the eyes.

The FDA advises, “Soft tissue fillers should be injected only by health care providers who have appropriate training and experience and who are knowledgeable about the anatomy at and around the injection site.”

The products are used by dermatologist, plastic and cosmetic surgeons, dentists, opthamologists, neurologists and neurosurgeons. 

Soft tissue fillers are injected directly into a treatment area. Successful results will depend on the patient’s overall health and skin condition, the skill of the health care provider, the location of injection and the type of filler used. Patients may need more than one injection to get the desirable smoothing/filling effect.

FDA Recommendations:

For Health Care Providers:

• Do not inject soft tissue fillers if you do not have the appropriate training or experience.
• Make sure that you are familiar with the anatomy at and around the site of injection, keeping in mind that blood vessel anatomy  can vary among patients.
• Before injection, thoroughly inform the patient of all risks of the procedure and the specific product you intend to use.
• Note that the approved indications for use of soft tissue fillers vary depending on the product. The FDA may not have reviewed use of soft tissue fillers in some locations in the body.
• Take extra care when injecting soft tissue fillers, for example inject the product slowly and apply the least amount of pressure necessary.
• Know the signs and symptoms  associated with injection into blood vessels, and have an updated plan detailing how you plan to treat the patient if this should this occur. This may include on-site treatment and/or immediate referral to another health care provider for treatment.
• Immediately stop the injection if a patient exhibits any signs or symptoms associated with injection into a blood vessel, such as changes in vision, signs of a stroke, white appearance (or blanching) of the skin, or unusual pain during or shortly after the procedure.
• Tell patients that they should seek immediate medical attention after the procedure if they experience signs and symptoms associated with injection into a blood vessel.
• Educate health care facility employees on how to quickly assist patients that report signs and symptoms of filler complications. They must understand how to instruct the patient to receive appropriate medical care.
• Report to the FDA and the manufacturer if you become aware of a patient experiencing an adverse event associated with unintentional injection of soft tissue filler into a blood vessel.

For Consumers:

• Before deciding to have soft tissue filler injections, talk with your health care provider about appropriate treatment injection sites and the risks associated with the procedure.
• Be aware that FDA reviewed and approved different products for use in certain areas of the face. The FDA may not have reviewed the use of certain soft tissue fillers for all locations in the body.
• Ask your health care provider about their training and experience injecting soft tissue fillers in the face.
• Read and discuss the patient labeling for the specific filler you are receiving. Your doctor can provide this information, or you can find it on the FDA’s website.
• Seek immediate medical attention if you develop symptoms such as unusual pain, vision changes, a white appearance of skin near the injection site, or any 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) during or shortly after the procedure.

FDA Actions:

The  FDA is working with manufacturers to update their labeling. The requests asks that the labeling include additional warnings, precautions, and other statements about the risk of unintentional injection into blood vessels, consistent with the recommendations in this communication, so that both health care providers and patients would have a better understanding of the risks.

Reporting Problems to the FDA:

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with these products.

If you suspect or experience a problem with soft tissue fillers, the FDA asks that you file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Additional Resources

• Soft Tissue Fillers (Dermal Fillers)
• Soft Tissue Fillers Labeling Request Letter to Industry
• Carruthers, J., Fagien, S., Rohrich, R., Weinkle, S., & Carruthers, A. (2014). Blindness caused by cosmetic filler injection: a review of cause and therapy . Plastic & Reconstructive Surgery.
• Ozturk, C. N., Li, Y., Tung, R., Parker, L., Piliang, M. P., & Zins, J. E. (2013). Complications Following Injection of Soft Tissue Fillers . Aesthetic Surgery Journal, 862-877.
• Carruthers, J. (2014). Discussion: New Anatomical Insights on the Course and Branching Patterns of the Facial Artery: Clinical Implications of Injectable Treatments to the Nasolabial Fold and Nasojugal Groove . Plastic & Reconstructive Surgery, 1083-1084