Why bone grafts of bovine origin are even better than other types of grafts

Yes, we use bovine femurs, and it is secure: why bone grafts of bovine origin are even better than other types of grafts.

What about product safety? This is one of the first questions that come to mind about Wishbone Xenograft. It's only natural when the agri-food sector has been repeatedly shaken by epidemics among cattle. The international crisis linked to the outbreak of mad cow disease, also known as bovine spongiform encephalopathy (BSE), in the 90s is still fresh in everyone's mind. In this article we will explain why our technology is perfectly safe to reconstruct the human jaw with, and why xenografts from bovine origin like Wishbone HA are actually even better than other types of bone grafts.

What is Wishbone HA (WHA) made of, exactly?

WHA is an organic bone graft composed of deproteinized hydroxyapatite from bovine origin. It is supplied as a mix of particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.

What are these particles used for? They are meant to fill, augment or reconstruct bony defects of the upper or lower jaw. We can think of them as a scaffold supporting new bone formation. When jaw reconstruction is complete, we get an integrated region composed of newly formed bone and xenograft particles that are in close contact with each other.

Bovine femurs, indeed, but not just any.

Did you know that bones in cattle were classified by the WHO as tissues with no BSE-detectable infectivity? Our bones are sourced from a unique qualified supplier. Bovine femurs used for WHA come from animals carefully selected: 24 months or younger cattle born, raised and slaughtered in Belgium. Why does young age matter? It is a risk-reducing factor. Let's mention as well that Belgium has strict animal feeding regulations, forbidding all animal derived protein feedings, and is ranked by the USDA as a country with negligible BSE risk. In addition, all of the bones we use are sourced from animals certified fit for human consumption, and inspected before and after slaughter by a certified veterinarian, which excludes the use of transmissible spongiform encephalopathy (TSE)-susceptible animals.

We also set up control steps ensuring the minimization of cross-contamination risk during slaughtering, collection, processing, handling, storage and transportation. Wishbone is thus complying with EN ISO 22442-2:2020 dedicated to controls on sourcing, collection and handling of animal tissues and their derivatives in medical devices.

A secure protocol, from collection to processing

What happens to our bovine femurs once they are collected? They are packaged individually in vacuum packages and placed in closed card box containers. Their transportation to Wishbone premises happens in a temperature-controlled environment. These bones are then sliced and go through processing steps which have been proven to remove and denature viruses and any bovine proteins, including prions (responsible for TSE).

So... no one will contract mad cow disease?

Not a chance. In order to evaluate the risks associated with the use of animal derivatives, Wishbone conducted a well-documented risk analysis. Our team then implemented a tight risk management protocol to address all aspects relating to viruses and TSE. Along with this approach, we make sure to stay up to date with security standards: Wishbone HA complies with EN ISO 14971:2019 (application of risk management to medical devices) and the ISO 22442 series. 

What does the research say?

Among available bone substitute materials used in clinical dental practice, bovine-derived bone substitute is one of the most documented in literature. A vast amount of in vitro, histological and clinical studies describing the osteoconductive properties of bovine-derived xenografts are available. The results are clear: when compared to xenografts originating from other species, synthetic bone grafts and auto-/allogenous bone grafts, xenografts from bovine origin demonstrate the best performance in terms of regenerated bone quality, density and evolution through time.

And what about safety? Here again, scientific literature is unequivocal about the safety profile of xenografts from bovine origin. They have been proven to be similar to synthetic bone grafts in terms of adverse events encountered while using the materials and failure rates after implants placement in regenerated regions.

Bovine-derived bone grafts, such as Wishbone HA, are a winning bet

What came out of the extensive literature review about bone grafts used in dentistry achieved by the Wishbone team is that the benefit/risk ratio attributed to bovine-derived bone grafts is higher than the one of synthetic materials. Indeed, as written above, if the reported performances of bovine-originated material are higher than those of synthetic materials whereas safety profiles are equal... Well, the math is simple. Bovine-derived particles are a material of choice when osteoconductivity properties equivalent to autogenous bone are wanted.

In short, a wide range of materials can be used for oral bone regeneration. Among them, xenogeneic bone from bovine origin is the best candidate, provided that safety is assured. On the basis of scientific data, Wishbone engaged with bovine-derived materials because they provide the highest potential of successful clinical outcomes while ensuring a reliable and sustainable supply. Alongside this, we implemented a rigorous protocol ensuring the high safety of the WHA product. And the work paid off! Wishbone obtained a certificate of suitability from the European Directorate for the Quality of Medicines & Healthcare (EDQM): WHA sourcing and manufacturing protocols are officially recognized to be secure in terms of TSE transmission.