Hyaluronic Acid (injectable)
Status
FDA-approved. FDA approval exists for numerous hyaluronic acid dermal fillers through the premarket approval device pathway for specific facial indications, and for certain intra-articular products. Labeling carries warnings on intravascular injection, including risk of vision abnormalities and blindness. Products are approved for specific sites, and use elsewhere in the face is off-label.
What it is
A gel used by clinicians for volume and hydration in the skin.
What published research measured
Injectable hyaluronic acid is regulated as a device rather than a drug in the United States, and cross-linked dermal fillers have substantial controlled evidence for soft tissue augmentation and correction of facial volume loss, with duration depending on the cross-linking chemistry. Separately, intra-articular hyaluronic acid for knee osteoarthritis has a large but contested evidence base — several major guidelines now recommend against it after meta-analyses found effects near or below the threshold for clinical importance. The serious risk of aesthetic injection is vascular: inadvertent intravascular placement or vessel compression can cause skin necrosis and, when it involves the ophthalmic circulation, permanent blindness. These events are rare, are documented in published case series, and are the reason anatomical training and immediate access to hyaluronidase are considered prerequisites.
Source
FDA premarket approval labeling for hyaluronic acid dermal fillers, including vascular occlusion warnings · Guideline recommendations against intra-articular hyaluronic acid for knee osteoarthritis
Sources
No linked primary source is on file for this entry yet.
Educational use only, never medical advice. No doses.