FDA requires label changes to dermal filler products

The FDA Center for Devices an Radiological Health (CDRH), acting on medical device reports, has raised concerns and requires labelling changes by Galderma (Restylane), Suneva (Artefill) and Actavis (Juv�derm), and other makers of dermal fillers. The FDA notes that soft tissue filler implants can be inadvertently injected into blood vessels causing rare but serious adverse events.These events are associated with intravascular injection of soft tissue filler material into the face and include (permanent or acute) vision impairment, blindness, cerebral ischaemia or cerebral haemorrhage leading to stroke, skin necrosis and damage to underlying facial structures.

The FDA therefore requires additional labelling to help practitioners understand the risks associated with intravascular injection of soft tissue implants and for the makers of these products to submit the labelling changes to the FDA.