Synthetic bone graft – a health risk assessment of degradants and a biocompatibility evaluation
A medical devices manufacturer.
Accelerated stability studies conducted on the polymer matrix of a synthetic bone graft (implant) identified a number of degradants that might (hypothetically) be released directly into the patients’ system following implantation. The matrix is purely an implantation aid and is excreted within a short time period. Additionally, biocompatibility studies and an implantation investigation were undertaken.
Bibra toxicologists were asked for an independent health risk assessment of the identified degradants (if the detected levels were seen in practice) and to evaluate the submitted biocompatibility studies.
Bibra estimated “worst-case” exposures that might result following implantation on the assumption that leaching might all occur on the day of implantation, or (less likely) be gradual over the time the matrix remains in the body. Experimental toxicity data and tolerable exposure values established by Expert Groups formed the basis of the health risk assessment. The submitted studies were assessed against the respective International Organization for Standardization (ISO) 10993 guidelines.
Bibra concluded that the organic degradants would not pose any significant health risks to patients exposed via leaching, at the estimated exposure levels, from the bone graft and provided reassurance that the submitted biocompatibility studies were conducted to a high standard.
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