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AMM 330: Bridging Safety Gaps in Aesthetic Medicine: Urgent Calls for Action
January 19, 2025
This episode delves into the critical issue of mandatory reporting for serious adverse events in aesthetic medicine. It highlights the existing gaps in data on the risks associated with injectables like fillers and neurotoxins due to voluntary reporting systems. Drawing attention to under-reporting, the episode discusses how this affects the development of evidence-based safety protocols. Esteemed experts advocate for a dedicated adverse event registry, aiming for a more immediate response to incidents. The episode challenges listeners to consider whether current measures are sufficient to ensure patient safety in aesthetic procedures.
Quick Takes
- There is a growing call for mandatory reporting of serious adverse events (SAEs) in the aesthetic medicine landscape due to a knowledge gap regarding the true incidence of risks associated with injectables like fillers and neurotoxins.
- The reliance on voluntary reporting systems has led to significant under-reporting, as evidenced by data from Canada’s MedEffect system, which revealed that most recorded adverse events related to neurotoxins were due to a lack of efficacy rather than safety concerns.
- Leading voices, like those in the Safety Task Force in 2024, emphasize the need for a dedicated adverse event registry to create a more structured system to track and respond to incidents with immediacy, rather than the current delays in safety data access seen, such as the five-year delay Health Canada experienced.
Episode Transcript
In today’s aesthetic medicine landscape, there’s a growing call for the mandatory reporting of serious adverse events or SAEs. This stems from an unsettling knowledge gap regarding the true incidence of risks associated with injectables like fillers and neurotoxins. These knowledge gaps hinder our ability to create evidence-based safety protocols. It’s often said, “You can’t manage what you don’t measure,” and that’s incredibly fitting here.
The heart of the issue is the reliance on voluntary reporting systems, which have shown significant under-reporting. For instance, data from Canada’s MedEffect system reveals that most recorded adverse events related to neurotoxins came forward due to a lack of efficacy rather than safety concerns. In fact, over half a century, only nine reports about filler-related issues were submitted. This discrepancy paints an incomplete picture of the safety landscape【4:0†source】.
Leading voices like those from the Safety Task Force in 2024, including prominent figures like Nikolis, emphasize the need for a dedicated adverse event registry. This would involve a more structured system, enabling us to track and respond to incidents with immediacy instead of a five-year delay, like the time it took Health Canada to provide access to safety data【4:0†source】.
On this 19th of January 2025, the question remains: Are we doing enough to safeguard patients undergoing aesthetic procedures, or is there more to be done to bridge this gap? Until next time, remember, well-informed is well-prepared!
