Few innovations have changed the face of cosmetic medicine more than the introduction of dermal fillers. Over the last several years, the number of available fillers has increased considerably. As this has happened, surgeons have evolved from the practice of filling lines to the concept of volume correction to restore a youthful appearance to the face.

Along with new fillers, enhanced applications, and areas of the face and body where these fillers are used, there has been a dramatic increase in the number and type of complications reported. How well are these products tested before entering the marketplace? In the United States, fillers approved by the Food and Drug Administration (FDA) undergo rigorous testing prior to approval. However, many fillers are licensed as medical devices, rather than as a drug, and as such, overall safety and efficacy testing is less demanding in the medical device category. The relative assurance of safety offered by FDA approval process does not address off-label cosmetic use of products approved for purposes other than cosmetic soft tissue augmentation. Further safety studies may not address the common cosmetic off-label use of approved fillers for purposes other than those specifically approved, or at least closely related to the FDA-approved uses. Silicone, calcium hydroxyapatite (Radiesse), and poly-L-lactic acid (Sculptra) have been the most glaring recent examples of widespread off-label use of products otherwise approved for narrowly described indications

In Europe, Canada, and much of the rest of the world, fillers are approved with relatively little serious human clinical data studies and woefully little safety data, and the concepts of professional and product liability applicable in the United States are largely nonexistent.