Good scientific practice of using worldwide post-marketing surveillance data to ensure safety with HAALI BDDE cross-linked hyaluronic acid fillers

Abstract

Background: Aliaxin fillers (HA_ALI), produced by IBSA Farmaceutici Italia SrL (Italy), are biodegradable, non-pyrogenic, 1,4-butanediol diglycidyl ether cross-linked hyaluronic acid (HA) hydrogels. The formulations are tailored for different clinical indications, ensuring precise and natural outcomes. Their cohesivity and tissue integration capabilities are associated with relatively few adverse events (AEs), supporting their widespread use in aesthetic treatments. This article examines the real-world safety profile of HA_ALI fillers derived from worldwide post-marketing surveillance data.

Methods: Post-marketing surveillance was registered by the manufacturer from January 2018 to September 2023. During this period, product complaints were globally gathered from healthcare practitioners and consumers, relating to technical issues or safety and productrelated adverse events.

Results: No discernible trend or substantial escalation in AEs across the entire product range were observed during the surveillance period (p>0.05). No statistically significant increases (p>0.05) in the frequency or severity of safety incidents and AEs were observed. The most frequently observed AEs were oedema (26%) and swelling (19%).

Conclusion: The analysed data further support and confirm the high safety profile of the HA_ALI fillers for different approaches in aesthetic medicine. This evaluation also highlights the importance of post-marketing analysis by continuing to foster a robust understanding of products currently used in daily clinical practice.