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Characteristics of Cobalt-Related Cardiomyopathy in Metal Hip Implant Patients: An Evaluation of 15 Published Reports

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Abstract

Over 300,000 hip replacements occurred in the USA in 2010, and the frequency is likely increasing annually. Blood Cobalt (Co) concentrations in patients with well-functioning cobalt–chromium (Co–Cr) hip implants are usually elevated above background concentrations relative to the general population. Excessive Co exposure, in rare cases, can result in cardiomyopathy. The purpose of this review was to identify cases of cardiomyopathy in metal-containing hip implant patients and to evaluate the possible cause of each patient’s cardiomyopathy. We evaluated 15 cases published between 2009 and 2016, and, based on a review of the preexisting risk factors, blood Co concentrations, and histopathological information published for each patient, they were stratified into one of four categories regarding the association between Co exposure and the development of cardiomyopathy: (1) Co was causal (five cases); (2) Co was contributory (two cases); (3) Co was possibly contributory (six cases); and (4) Co was non-causal (two cases). In all 15 cases, blood Co concentrations (14–6521 μg/L) were elevated beyond levels associated with the majority of metal-containing implant patients (0.1–10 μg/L), and, in many cases, there was evidence of a malfunctioning implant. The data indicate that individuals with well-functioning implants, even those with preexisting risk factors, are at no risk of developing cardiac effects. We conclude that blood Co measurements are informative, but should be interpreted with caution, and in context of other factors evaluated in this analysis. The mere presence of elevated Co is not sufficient to indicate causation for a patient’s cardiomyopathy.

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  1. Brooke E. Tvermoes

    Present address: IBM, Boulder, CO, USA

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  1. Cardno ChemRisk, 65 Enterprise, Suite 150, Aliso Viejo, CA, 92656, USA

    Ernest S. Fung & Michael Kovochich

  2. Cardno ChemRisk, 101 2nd St. Suite 700, San Francisco, CA, 94105, USA

    Andrew Monnot, David Galbraith & Dennis J. Paustenbach

  3. Cardno ChemRisk, 20 Stanwix St. Suite 505, Pittsburgh, PA, 15222, USA

    Kenneth M. Unice

  4. Cardno ChemRisk, 4940 Pearl East Circle Suite 100, Boulder, CO, 80301, USA

    Brooke E. Tvermoes

  5. Cardno ChemRisk, 231 Front St. Suite 212, Brooklyn, NY, 11201, USA

    Brent L. Finley

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Conflict of interest

All of the authors (EF, AM, MK, KU, BT, DG, BF, and DP) are or were employed by Cardno ChemRisk, a consulting firm that provides scientific advice to the government, corporations, law firms, and various scientific/professional organizations. Cardno ChemRisk has been engaged by DePuy Orthopaedics, Inc., a manufacturer of prosthetic devices, some of which contain cobalt and chromium, to provide general consulting and expert advice on scientific matters, as well as litigation support. Funding for the preparation of this paper was provided by DePuy. This work was supported by DePuy and they agreed, at the time of funding, that the findings would be published irrespective of the results. This paper was prepared and written exclusively by the authors, without review, or comment by DePuy employees or counsel. This work may be relied upon in medical research and litigation. One of the authors (DJP) has previously testified on behalf of DePuy in hip implant litigation. It is possible that any or all of the authors may be called upon to serve as expert witnesses on behalf of DePuy. The preparation of the paper, including conduct of the literature review, review of the individual papers, integration and synthesis of the findings, the conclusions drawn, and recommendations made are the exclusive professional work product of the authors, and may not necessarily be those of their employer or the financial sponsor of the review.

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Fung, E.S., Monnot, A., Kovochich, M. et al. Characteristics of Cobalt-Related Cardiomyopathy in Metal Hip Implant Patients: An Evaluation of 15 Published Reports. Cardiovasc Toxicol 18, 206–220 (2018). https://doi.org/10.1007/s12012-017-9433-z

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