(Reuters) — The FDA today asked manufacturers of dermal fillers to update their labeling to reflect the possible risk of serious injuries caused by unintentional injection of the fillers into the blood vessels in the face.
The federal safety watchdog said it reviewed information suggesting that the fillers could block blood vessels and restrict blood supply to tissues.
That could potentially lead to vision impairment, blindness, stroke and damage and/or death of the skin and underlying facial structures, the FDA said.
Although current labeling includes some information about this risk, the FDA said it believed that additional information could be included to better inform health care providers and patients.
"Rare but serious adverse events that are associated with intravascular injection of soft tissue filler material in the face include (acute or permanent) vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, and damage to underlying facial structures," according to the agency.