May 28, 2015 — Soft-tissue fillers, including chin implants and wrinkle injections, are associated with a number of disfiguring and debilitating side effects when they are accidentally injected into blood vessels, according to a Safety Communication issued by the FDA.
The agency was particularly concerned about injections into the skin between the eyebrows and nose (glabella), forehead, around the eyes, and around the nose. Manufacturers must update the labels to include this information.
Some complications could even be life-threatening:
“Unintentional injection can block blood vessels and restrict blood supply to tissues. Sometimes this can result in embolization. This means the filler material has traveled to other parts of the body. This can cause vision impairment, blindness, stroke and damage and/or death of the skin (necrosis) and underlying facial structures.”
The warning was issued after researchers published a study involving 61 patients who had severe side effects after receiving a soft-tissue filler.
According to the researchers, necrosis was most commonly associated with injections into the nose, followed by injections into the nasolabial fold (“smile lines”). Injections into the glabella were associated with blindness. About 1/10,0000 patients who received soft-tissue injections experienced severe side effects.
The FDA recommended seeking emergency medical treatment for the following symptoms:
- Unusual pain
- Vision changes
- A white appearance of the skin near the injection site (blanching)
- Any signs of a stroke (sudden problems speaking, numbness or weakness in the arms, face, legs, difficulty walking, face drooping, headache, dizziness, and confusion)
Last year, the FDA issued a similar warning about complications like blindness and scarring if dermal fillers were accidentally injected into blood vessels.
The FDA also warned about a product called Expression Injectable, which was being marketed “off-label” as an injectable filler when it was not approved for that purpose. Several people were severely injured, including one person who was disfigured by permanent nodules on the face.
The FDA also reminded patients and doctors that there are many types of soft-tissue fillers. They are approved for different purposes and not all have been evaluated as safe or effective for use on the face.