{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T02:43:56Z","timestamp":1790822636215,"version":"4.1.0"},"reference-count":13,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,5,18]],"date-time":"2026-05-18T00:00:00Z","timestamp":1779062400000},"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                    Biodegradable polymers (BPs) present unique challenges for chemical characterization and toxicological risk assessment. Methodological requirements for devices with prolonged tissue contact often involve exhaustive extraction\u2014an approach impractical for many BPs due to their degradability and incompatibility with common solvents. This paper proposes a hybrid approach to TRA for BPs, beginning with compositional profiling to estimate the total quantity of each polymer in a device and applying worst-case assumptions for complete hydrolysis into monomeric constituents. A biodegradable vessel closure system composed of a glycolide-caprolactone-trimethylene carbonate (GA-CL-TMC) copolymer, combined with a poly(glycolide-lactide) (PLGA) suture and polyethylene glycol (PEG) sealant, is applied as a case study. Estimated exposure doses (EED\n                    <jats:sub>max<\/jats:sub>\n                    ) are calculated for acute, subacute, subchronic, and chronic durations using the assumed release model defined in ISO 10993-17:2023. Where initial margins of safety (MOS) are low, refined exposure estimates are then derived using in vitro\u2013in vivo correlation (IVIVC) data. Degradation-based release kinetics provide exposure scenarios that more accurately reflect\n                    <jats:italic>in vivo<\/jats:italic>\n                    conditions, offering a conservative yet physiologically plausible basis for acute and subacute exposure estimates. This approach demonstrates that compositional profiling, supplemented with IVIVC data, offers a practical and conservative framework for assessing systemic toxicological risk posed by BPs. These methods only account for BP degradation products and should be augmented with additional methods to address manufacturing residues.\n                  <\/jats:p>","DOI":"10.3389\/ftox.2026.1766769","type":"journal-article","created":{"date-parts":[[2026,5,18]],"date-time":"2026-05-18T05:43:59Z","timestamp":1779083039000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["Compositional profiling for biodegradable medical devices: a framework for degradation-informed exposure and risk assessment"],"prefix":"10.3389","volume":"8","author":[{"given":"Jared","family":"Wilsey","sequence":"first","affiliation":[{"name":"Abbott Vascular","place":["Santa Clara, CA, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Inga","family":"Potapova","sequence":"additional","affiliation":[{"name":"Abbott AG","place":["Baar, Switzerland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaoping","family":"Wu","sequence":"additional","affiliation":[{"name":"Abbott Laboratories","place":["St. Paul, MN, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mao-wen","family":"Weng","sequence":"additional","affiliation":[{"name":"Abbott Laboratories","place":["St. Paul, MN, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matt","family":"Lewis","sequence":"additional","affiliation":[{"name":"Abbott Laboratories","place":["St. Paul, MN, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haibo","family":"Wang","sequence":"additional","affiliation":[{"name":"Abbott Vascular","place":["Santa Clara, CA, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Echoleah","family":"Rufer","sequence":"additional","affiliation":[{"name":"Abbott Vascular","place":["Santa Clara, CA, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dan","family":"Bellows","sequence":"additional","affiliation":[{"name":"Abbott Vascular","place":["Santa Clara, CA, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marika","family":"Kamberi","sequence":"additional","affiliation":[{"name":"Abbott Vascular","place":["Santa Clara, CA, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,5,18]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"1","DOI":"10.19080\/NAPDD.2017.02.555589","article-title":"Modelling of drug release from a polymer matrix system","volume":"2","author":"Achenie","year":"2017","journal-title":"Nov. Approaches Drug Des. Dev."},{"key":"B2","doi-asserted-by":"publisher","first-page":"476","DOI":"10.1093\/toxsci\/kfi119","article-title":"Development of a physiologically based pharmacokinetic model for ethylene glycol and its metabolite, glycolic acid, in rats and humans","volume":"85","author":"Corley","year":"2005","journal-title":"Toxicol. Sci."},{"key":"B3","volume-title":"Registration dossier for glycollic acid (CAS 79-14-1)","year":"2020"},{"key":"B4","volume-title":"Registration dossier for Ethane-1,2-diol (CASRN 107-21-1)","year":""},{"key":"B5","volume-title":"Registration dossier for Undecan-1-olide (CASRN 104-67-6)","year":""},{"key":"B6","volume-title":"Registration dossier for Propane-1,3-diol (CASRN 504-63-2)","year":""},{"key":"B7","doi-asserted-by":"publisher","first-page":"3489","DOI":"10.1002\/pol.20220551","article-title":"Organocatalytic depolymerization of poly(trimethylene carbonate)","volume":"60","author":"Fukushima","year":"2022","journal-title":"J. Polym. Sci."},{"key":"B8","doi-asserted-by":"publisher","first-page":"9895","DOI":"10.1021\/acs.est.3c04423","article-title":"Oligomers and monomers from biodegradable plastics: an important but neglected threat to ecosystems","volume":"57","author":"Hu","year":"2023","journal-title":"Environ. Sci. Technol."},{"key":"B9","volume-title":"Biological evaluation of medical devices part 17: toxicological risk assessment of medical device constituents","year":"2023"},{"key":"B10","doi-asserted-by":"publisher","first-page":"42","DOI":"10.63345\/ijrmp.v14.i4.6","article-title":"Development of biodegradable polymers for controlled drug release","volume":"14","author":"Kohli","year":"2025","journal-title":"Int. J. Res. Manag. and Pharm."},{"key":"B11","doi-asserted-by":"publisher","first-page":"e0285515","DOI":"10.1371\/journal.pone.0285515","article-title":"Chemical reactivity theory to analyze possible toxicity of microplastics: polyethylene and polyester as examples","volume":"19","author":"Martinez","year":"2024","journal-title":"PLoS One"},{"key":"B12","volume-title":"SIDS initial assessment profile for lactic acid (CASRN 50-21-5)","year":"2008"},{"key":"B13","article-title":"FY2018 regulatory science research report: long-acting injectables and implants","year":"2018","journal-title":"Silver Spring (MD) FDA Office Generic Drugs"}],"container-title":["Frontiers in Toxicology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/ftox.2026.1766769\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,18]],"date-time":"2026-05-18T05:44:06Z","timestamp":1779083046000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/ftox.2026.1766769\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,18]]},"references-count":13,"alternative-id":["10.3389\/ftox.2026.1766769"],"URL":"https:\/\/doi.org\/10.3389\/ftox.2026.1766769","relation":{},"ISSN":["2673-3080"],"issn-type":[{"value":"2673-3080","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,18]]},"article-number":"1766769"}}