Soft Tissue Fillers Can Cause Severe Side Effects and Stroke When Injected Into Blood Vessels, FDA Warns

The U.S. Food and Drug Administration (FDA) is warning dermatologists, plastic surgeons, cosmetic surgeons, dentists and medical providers who treat patients using soft tissue fillers that unintentionally injecting soft tissue fillers into blood vessels can cause rare but serious side effects, including stroke.

In a Safety Communication posted on the agency’s website dated May 28, the FDA explained that soft tissue fillers create a smoother or fuller appearance of the face, and are FDA-approved to reduce the appearance of wrinkles or to augment lips of cheeks. They are injected directly into the treatment area, and patients may need more than one injection to get the desired effect, the communication explains.

If a health care worker unintentionally injects the filler into blood vessels in the face, the blood vessels may become blocked or restrict blood supply to tissues, potentially resulting in embolization. If filler material travels to other parts of the body, it can cause vision impairment, blindness, stroke and damage and/or skin necrosis, as well as damage to underlying facial structures.

The FDA found adverse event reports in the agency’s literature showing that blood vessel blockage most typically occurs when the fillers are injected directly between the eyebrows and nose (glabella), in and around the nose, forehead, and around the eyes (periorbital region).

Patients should speak with their health care provider concerning appropriate treatment injection sites and the risks associated with the procedure before having it done, the agency said in the communication, pointing out that the FDA may not have reviewed the use of certain soft tissue fillers for all locations in the body. Patients should consult their health care provider about what training and experience they have in injecting soft tissue fillers into the face. The agency says patients should also read and discuss the patient labeling for the specific filler they are receiving.

Health care workers should immediately stop the injection if the patient shows signs or symptoms 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. Patients should seek immediate medical attention after the procedure if they experience any of these symptoms, or symptoms of a stroke, which include sudden difficulty speaking, numbness or weakness in the face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness or confusion.

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