Current Practice of In Vivo Hernia Mesh Testing Lacks Standardization

in vivo hernia mesh testing

Manufacturers and their scientists have tested several mesh products and sold them for decades. But the question remained on whether the test method is good enough to determine the mesh’s durability and longevity, as recent research indicates in vivo hernia mesh testing is lacking

There are about 70 mesh products in the market. Researchers test hernia mesh in vivo. This means testing the surgical device on live animal subjects on one part and then explanting it. Scientists call it biomechanical and histological assessments. 

Recently, a team involving T. Whitehead-Clarke and R. Karanjia studied the in vivo hernia mesh testing method. They used relevant study materials from Medline and Embase. The team identified 513 articles and excluded 231 duplicates. 

Whitehead-Clarke, Karanjia, and other team members used the standardized form to extract the data they needed. They discovered that 53% of mesh testing involves rats, and 78% of studies involved formation defects. 

Out of that number, facia is unexposed at 52%. The study showed that the standard hernia models use mesh to bridge a critical defect of 50%. The team discovered that at 63%, tensile strength testing is the most common form of mechanical experiments involving hernia mesh. 

Finally, the team identified the testing strip widths and test speeds vary significantly at 4-30 mm and 1.625-240 mm/min, respectively. It showed little consensus in the units used for tensile strength experiments. 

The study showed that collagen’s assessment is for its abundance, not alignment. The latter is not measured quantitatively, and at least 21 histological scoring systems are used for in vivo testing. 

At the end of the research, the researchers concluded that in vivo hernia mesh testing lacks standardization. Each experiment category has significant inconsistency, as well as methodology and comparators. Thus, there is a need for hernia organizations and materials testing institutions to discuss the need for a more standardized approach. 

If you have been injured by a defective mesh medical device, you need to contact a mass tort attorney.

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