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NICK BEIJER: At RIVM we develop new 
methods to assess implant safety.

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We do this based on the complaints 
patients get...

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and in a human relevant In vitro model. 

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VOICE OVER: Every year, millions 
of people around the world...

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receive medical implants 
as a treatment.

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Implants greatly differ, such as 
large joint replacements...

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silicone breast implants 
and mesh-materials.

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In most patients, the function 
of damaged tissues or organs...

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 is successfully restored.

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But in some patients, 
complications...

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such as pain due to excessive fibrosis,
do occur.

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 NICK BEIJER: Before an implant reaches 
the clinic, it is thoroughly tested on safety.

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This is mainly done in tests based on 
the chemical nature of the material.

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But more recently we have learned 
that also the mechanical forces...

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play a significant role 
in the host response.

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That is why we want to update 
the current testing strategies...

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by also including these 
mechanical forces...

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and by this resembling the interface...

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between the biomaterial 
and the patient better.

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And have an animal-free method 
to mimic the host response.

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VOICE OVER: RIVM is working on two
parallel lines of research to achieve this.

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 Which involve both studying human tissues 
and setting up cell-based systems.

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NICK BEIJER: Firstly, 
we want to understand...

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what causes the adverse effects
in patients.

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 For this, we examine explanted materials 
from patients who developed complaints.

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This is a bit of the biomaterial with 
the surrounding tissue together...

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 and we analyse this using histopathology, 
transcriptomics or proteomics for example.

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Secondly, we have developed an in vitro 
model of direct cell-biomaterial interaction... 

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in which cells are exposed to chemical as 
well as mechanical forces at the same time.

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By doing this, the cells 
cannot only experience...

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 the chemical nature of the material...

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but at the same time also 
its surface structure, its stiffness...

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as well as its shape and size.

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In this way we can assess more relevant 
biomaterial properties at the same time...

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and check their influence 
on the host response

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VOICE OVER: By combining insights 
from implant-tissue histopathology...

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with current knowledge 
from the literature...

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an Adverse Outcome Pathway or 
AOP network will be constructed.

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NICK BEIJER: We use the AOP 
as a guide to highlight mechanisms...

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to be targeted in the 
direct-interaction in vitro model.

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By looking at these key events 
in the in the in vitro model...

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we will be able to describe the host 
response more accurately...

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and in this way improve 
implant safety on the long term.