Carcinogenic hazard assessment of cobalt-containing alloys in medical devices: Review of in vivo studies

• DOI: 10.1016/j.yrtph.2021.104910
• Publication Date: 2021-03-01T15:36:31Z
• Authors: Michael Kovochich; Andrew Monnot; Daniel G. Kougias; Sharlee L. More; Jared T. Wilsey; Qing-Qing Qiu; Laura E.L. Perkins; Philippe Hasgall; Maneesh Taneja; Edward E. Reverdy; Jorge Sague; Stephen Marcello; Kevin Connor; James Scutti; Whitney V. Christian; Paul Coplan; Laurence B. Katz; Mark Vreeke; Millie Calistri-Yeh; Brenda Faiola; Kenneth Unice; Gary Eichenbaum
• Keywords: 0301 basic medicine; 03 medical and health sciences; Equipment and Supplies; Carcinogenesis; Alloys; Animals; Humans; Cobalt; 3. Good health

Cobalt (Co) alloys have been used for over seven decades in a wide range of medical devices, including, but not limited to, hip and knee implants, surgical tools, vascular stents, due to their favorable biocompatibility, durability, mechanical properties. A recent regulatory hazard classification review by the European Chemicals Agency (ECHA) resulted metallic Co as Class 1B Carcinogen (presumed carcinogenic potential humans), primarily based on inhalation rodent carcinogenicity studies with pure Co. The ECHA did specifically consider forms or routes that are relevant devices. purpose this is present comprehensive assessment available vivo preclinical data exposure Co-containing (CoCA) devices routes. In were reviewed from 33 examined impact local systemic tumor incidence rats, mice, guinea pigs, hamsters. Across these studies, there was no significant increase tumors Taken together, led conclusion CoCA models. While specific patient implant factors cannot be fully replicated using models, support unlikely patients.