Introduction
Evidence & Methods
Allograft bone is commonly used in spine surgery, but its safety has been insufficiently examined.
This study is a retrospective review of FDA-recall data as it pertains to musculoskeletal tissue and disease transmission to spine surgery patients. The authors conclude that there is no apparent “overt” risk to the use of allograft tissue in spine surgery. The authors make recommendations for doing ‘the best we can’ to protect our patients.
There is no method used in the United States to prospectively follow and audit safety in the diverse allograft used in spinal surgery. Without this in place the actual safety of allograft tissues is difficult to assess. Surgeons and patients rely upon the integrity of a collection, testing and distribution system with a questionable history and evolving and unproven safe-guards.
—The Editors
Allograft bone is used commonly in spinal surgery, and has important utility in fusion and reconstructive surgery. Obvious benefits of the use of allograft bone include decreased operative time and blood loss; decreased donor site morbidity; and obviation of the need to sacrifice rib(s), fibula, or other sources of autogenous bone. Recent reports of massive recalls of allograft tissue by Food and Drug Administration (FDA) have raised concerns about the safety of allograft bone for the use in spinal surgery. Clearly, if disease transmission in spinal surgery was to become prevalent, it would force an avoidance of allograft bone. This would result in a major change in the types of surgeries performed and quite possibly, an alteration of clinical outcomes.
Despite the widespread use of allograft bone in the spine surgery, uncertainty about its safety is prevalent given the recent reports of recipient disease transmission in other subspecialties after the use of allograft tissue. Furthermore, there is a paucity of literature that defines the risk of allograft bone specifically for spine surgery patients.
The purpose of the study was to analyze recall data, to assess the safety of allograft bone, and to provide guidelines that spinal surgeons can follow to optimize the safe use of this tissue.