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Adverse reactions and events related to musculoskeletal allografts: reviewed by the World Health Organisation Project NOTIFY

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Abstract

Purpose

The use of bone and connective tissue allografts has grown rapidly and surpassed the use of autografts in many countries. Being of human origin, bone and tendon allografts carry the risk of disease transmission and complications have been reported. As part of the Project NOTIFY led by the World Health Organisation, an effort to improve recognition, reporting, tracking and investigation of adverse outcomes of allografts was initiated, achieving a comprehensive review of associated disease transmission and failures. Those involving the use of musculoskeletal allografts are reported here. A major objective is to involve orthopaedic surgeons in the improvement of the safe use of the musculoskeletal allografts.

Methods

We reviewed the medical literature, requested reports from surgeons in selected professional organisations and informally surveyed tissue bank organisations and selected tissue bank professionals to discover reported and unreported cases of adverse outcomes. We analysed each case to decide the likelihood that the complication was truly allograft related.

Results

The efficiency of the procedures involved in bone banking and bone and tendon allograft has improved significantly during the last three decades. The evolution of the incidence of reported adverse reactions and events reflects positively on the safety of transplanted tissues. Cases of bacterial and viral transmission by bone and tendon allografts occurred mainly with those that contained viable cells, were not processed to remove cells, or were not disinfected or sterilised. We documented cases of transmission of human immunodeficiency virus (HIV), hepatitis C virus (HCV), human T-lymphotropic virus (HTLV), unspecified hepatitis, tuberculosis and other bacteria. Reporting of these adverse outcomes has led to corrective actions and has significantly improved the safety of allograft use. However, it is probable that not all cases have been reported and investigated.

Conclusions

Considering the high quality standards achieved in many countries, the best approach for further improvement in the safety of allografts is through a systematic reporting of all serious adverse reactions and events in the context of a global biovigilance programme.

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Authors and Affiliations

  1. Department of Orthopaedic Surgery and Traumatology, Hôpital Erasme, Brussels University, 808 route de Lennik, 1070, Brussels, Belgium

    M. Hinsenkamp

  2. Antwerp University Hospital, Edegem and Antwerp University, Antwerp, Belgium

    L. Muylle

  3. Federal Agency for Medicines and Health Products, Brussels, Belgium

    L. Muylle

  4. Division of Transfusion Medicine, Dept. of Pathology, University of New Mexico, School of Medicine, Albuquerque, NM, USA

    T. Eastlund

  5. Italian National Transplant Centre, National Institute of Health, Rome, Italy

    D. Fehily

  6. Health System Governance and Service Delivery, World Health Organization-HQ, Geneva 27, Switzerland

    L. Noël

  7. Department of Orthopaedics and Sports Medicine, University of Washington School of Medicine, Seattle, WA, USA

    D. M. Strong

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  1. M. Hinsenkamp
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  2. L. Muylle
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  3. T. Eastlund
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  4. D. Fehily
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  5. L. Noël
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  6. D. M. Strong
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Correspondence to M. Hinsenkamp.

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Hinsenkamp, M., Muylle, L., Eastlund, T. et al. Adverse reactions and events related to musculoskeletal allografts: reviewed by the World Health Organisation Project NOTIFY. International Orthopaedics (SICOT) 36, 633–641 (2012). https://doi.org/10.1007/s00264-011-1391-7

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  • DOI: https://doi.org/10.1007/s00264-011-1391-7

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