2025 / Post-marketing spontaneous-report surveillance
A reporting rate is not a complication rate.
How should a very low surveillance percentage be interpreted?
Source access: publication abstract
The study#
- Design
- Post-marketing spontaneous-report surveillance
- Population
- Estimated global exposure; face and body analysed separately
- Follow-up / endpoint
- Face reports: January 2018–October 2023
- Source
- Journal of Cosmetic Dermatology, 2025 · PMID 40654100
What the authors found#
The authors reported 371 adverse events for facial Profhilo against projected exposure of about 1.09 million patients.[1]
Editorial interpretation
Why it is interesting#
A useful safety-signal dataset, with an estimated rather than directly observed denominator.
Use surveillance to investigate signals; use prospective data to estimate event frequency.
What it cannot tell us#
- Spontaneous reporting misses events and is subject to reporting bias.
- Estimated exposure and separate Body data prevent treating the reported proportion as a prospective incidence rate.
Selection for this library reflects educational interest. It is not a systematic search, formal certainty grade, or complete account of the literature.
Funding & commercial context#
Several authors are affiliated with IBSA. See the full publication for its funding and conflict-of-interest statements.
Continue with the product
Source & citation#
Salti et al. — HCC-HA post-marketing surveillance ↗Checked 2026-09-06 · Journal of Cosmetic Dermatology, 2025 · PMID 40654100. Cite the original publication when discussing its results; this page is an interpretation.
Aesthetic Pass. A reporting rate is not a complication rate. Product Atlas research interpretation 2026.09.06.1. https://aestheticpass.com/products/studies/profhilo-surveillance-denominators/