Long-term 23-year Global Post-marketing Safety Surveillance Review of Delayed Complications with a Supportive Hyaluronic Acid Filler for Infraorbital Hollow Rejuvenation.

Abstract

HA_RES is a supportive (high G') HA filler with a low degree of water affinity (gel swelling) and modification (<1% BDDE) that has a well-established safety and efficacy profile in the literature, especially for infraorbital hollow (IOH) rejuvenation. To further support the safety of this product, a long-term review of delayed-onset adverse events of interest (DAEIs) related to HA_RES was conducted using reports from a global post-marketing safety surveillance database over the past 23 years. This review demonstrated low reporting frequencies of delayed-onset nodules and inflammatory events, establishing a long-term safety profile for HA_RES that supports its continued use in clinical practice, especially for IOH rejuvenation.