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Frontiers in Toxicology· 2026Q1

Foreign body reaction: towards a macrophage-centered adverse outcome pathway for fibrotic encapsulation

Tom Meseberg, Susanne Kurz, Juliane Spohn

Short summary

This paper proposes a macrophage-centered Adverse Outcome Pathway (AOP) framework to better understand and assess the foreign body reaction (FBR), a key cause of medical device complications.

AI-generated from the title and abstract; the full text is not read.

Key points

  • The foreign body reaction (FBR) causes chronic inflammation and fibrotic capsule formation around medical devices.
  • Existing in vivo preclinical risk assessment methods for FBR have limitations including species differences and ethical concerns.
  • An Adverse Outcome Pathway (AOP) framework, focusing on macrophages, is proposed to mechanistically understand FBR.
  • This AOP framework can guide the development of in vitro assays for early screening of low-FBR materials.

AI-generated from the title and abstract; the full text is not read.

Abstract

The foreign body reaction (FBR), characterized by chronic inflammation and fibrotic capsule formation around implanted medical devices, remains a major cause in device-related complications. Current preclinical risk assessment relies on in vivo testing according to ISO 10993-6:2024, which are limited by species differences, incomplete mechanistic insight, and ethical concerns. Additionally, ISO/TS 10993-20:2006 outlines immunotoxicity knowledge regarding implant-induced effects such as FBR and specifies a collection of in vitro assays. The perspective presented here, aims to explore the applicability of the Adverse Outcome Pathway (AOP) framework to FBR in order to integrate evidence and methods into a structured mechanistic context and facilitate the application of in vitro tests in preclinical risk assessment of FBR. A targeted literature review was conducted to identify and organize biological mechanisms into a putative AOP, map available new approach methodologies, and highlight critical knowledge gaps and uncertainties. This initial framework may guide early screening for low-FBR materials and support mechanistically anchored, non-animal biocompatibility assessment strategies for medical devices.

The authors' abstract, as published at the source. Frontiers in Toxicology, 2026 · DOI ↗

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