{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T07:09:12Z","timestamp":1792480152595,"version":"4.5.0"},"reference-count":107,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,2,4]],"date-time":"2026-02-04T00:00:00Z","timestamp":1770163200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Toxicol."],"abstract":"<jats:p>\n                    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\n                    <jats:italic>in vivo<\/jats:italic>\n                    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\n                    <jats:italic>in vitro<\/jats:italic>\n                    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\n                    <jats:italic>in vitro<\/jats:italic>\n                    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.\n                  <\/jats:p>","DOI":"10.3389\/ftox.2026.1735871","type":"journal-article","created":{"date-parts":[[2026,2,3]],"date-time":"2026-02-03T22:10:12Z","timestamp":1770156612000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":11,"title":["Foreign body reaction: towards a macrophage-centered adverse outcome pathway for fibrotic encapsulation"],"prefix":"10.3389","volume":"8","author":[{"given":"Tom","family":"Meseberg","sequence":"first","affiliation":[{"name":"Bio- and Nanotechnology Department, Fraunhofer Institute for Ceramic Technologies and Systems (FHG)","place":["Dresden, Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susanne","family":"Kurz","sequence":"additional","affiliation":[{"name":"Bio- and Nanotechnology Department, Fraunhofer Institute for Ceramic Technologies and Systems (FHG)","place":["Dresden, Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juliane","family":"Spohn","sequence":"additional","affiliation":[{"name":"Bio- and Nanotechnology Department, Fraunhofer Institute for Ceramic Technologies and Systems (FHG)","place":["Dresden, Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,2,4]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"4015","DOI":"10.1021\/acs.biomac.9b01098","article-title":"Anti-inflammatory surface coatings based on polyelectrolyte multilayers of heparin and polycationic nanoparticles of naproxen-bearing polymeric drugs","volume":"20","author":"Al-Khoury","year":"2019","journal-title":"Biomacromolecules"},{"key":"B2","doi-asserted-by":"publisher","DOI":"10.3390\/polym13071135","article-title":"Preliminary biocompatibility tests of Poly-\u03b5-Caprolactone\/Silver nanofibers in wistar rats","volume":"13","author":"\u00c1lvarez-Ortega","year":"2021","journal-title":"Polym. 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