The U.S. Food and Drug Administration is warning health care providers and consumers about potential dangers associated with soft tissue fillers that are usually injected into the face for cosmetic purposes.
These dermal fillers are approved by the FDA for the treatment of wrinkles and augmented lips and cheeks, but if they are unintentionally injected into blood vessels, serious complications can occur.
The rare but severe side effects associated with unintentional injection of soft tissue fillers into blood vessels include blocked vessels and restrictions of blood supply to the affected tissue. This can lead to embolization, in which the filler travels to other parts of the body. These complications are associated with: "vision impairment, blindness, stroke and damage and/or death of the skin (necrosis) and underlying facial structures."
"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 identifies certain injection locations where blood vessel blockage have been reported more often. These sites include the skin between the eyebrows and nose (glabella), in and around the nose, forehead, and around the eyes (periorbital region)," the FDA stated.
In order to avoid these complications, the FDA is urging those who do not have appropriate training to refrain from injecting the fillers into patients. They are also asking healthcare providers to inform patients of the potential risk before injection and to take extra care when administering them. It is also important for consumers to be aware of the warning signs of complications, and have a plan for how they will be treated if this does occur.
"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," the FDA stated.
The FDA is now working with manufacturers to update the labeling of the fillers to include additional warnings and precautions. They ask any healthcare providers and consumers to report any adverse effects to MedWatch, the FDA Safety Information and Adverse Event Reporting program.
