Studies on cobalt use in medical devices show there is no alternative material with a better combination of physical properties and historical track record

The Cobalt Institute examined a series of scientific publications authored by experts in the medical devices sector, critically reviewing the hazards and summarizing the benefits of the use of cobalt in medical devices such as implants, stents or scalpels. Studies have shown that cobalt-containing alloys that are used to build medical devices have a long history of safe use and unique properties of biocompatibility, corrosion resistance, strength and durability, as well as low risks. The publications also highlighted that there are currently no alternative materials with a better combination of physical properties and historical database of use.

In terms of any hazard relating to cancer with cobalt-containing devices, over 33 animal studies were analyzed, supported by 20 publications on patients with implants, and concluded that it was unlikely medical devices would cause cancer in humans. In addition, data related to hazards associated with the reproductive system were evaluated and it was similarly concluded that it would be extremely unlikely to see this toxicity associated with medical devices containing cobalt. In conclusion and summarized in a benefit-risk assessment, studies have shown that cobalt-containing alloys that are used to build medical devices have a long history of safe use and unique properties of biocompatibility, corrosion resistance, strength and durability, as well as low risks.

Full references can be obtained from the Cobalt Institute, abbreviated references as follows in the journal Regulatory Toxicology and Pharmacology:

Eichenbaum et al. 2021; Kovochich et al., 2021; Monnot et al., 2021. Zhang et al., 2021[1]

[1] Eichenbaum G, Wilsey JT, Fessel G, Qiu QQ, Perkins L, Hasgall P, Monnot A, More SL, Egnot N, Sague J et al. 2021. An integrated benefit-risk assessment of cobalt-containing alloys used in medical devices: Implications for regulatory requirements in the european union. Regul Toxicol Pharmacol. 125:105004.

Kovochich M, Monnot A, Kougias DG, More SL, Wilsey JT, Qiu QQ, Perkins LEL, Hasgall P, Taneja M, Reverdy EE et al. 2021. Carcinogenic hazard assessment of cobalt-containing alloys in medical devices: Review of in vivo studies. Regul Toxicol Pharmacol. 122:104910.

Monnot AD, Kovochich M, Bandara SB, Wilsey JT, Christian WV, Eichenbaum G, Perkins LEL, Hasgall P, Taneja M, Connor K et al. 2021. A hazard evaluation of the reproductive/developmental toxicity of cobalt in medical devices. Regul Toxicol Pharmacol. 123:104932.

Zhang S, Holy CE, Eichenbaum G, Perkins LE, Hasgall P, Katz LB, Brown JR, Orlandini L, Fessel G, Nasseri-Aghbosh B et al. 2021. Carcinogenic assessment of cobalt-containing alloys in medical devices or cobalt in occupational settings: A systematic review and meta-analysis of overall cancer risk from published epidemiologic studies. Regul Toxicol Pharmacol. 125:104987.