Part 2
XLP
Part of my hospital notes - October 2014
... at the time, I urgently wanted to have this toxic MOM hip removed from my body.
In the early days of Pinnacle Ultamet no one knew how poor they would be in terms of durability and safety - not even DePuy. Patients expectations were that they would be better than other prostheses, because of DePuy's claims.
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At the trial, the DuPuy argued (as they had in U.S. Trials) that the only reasonable way to assess Ultamet performance was to compare it with other hips on the market in 2002, it was introduced.
A few points ...
1. If DePuy had performed effective testing, before releasing Ultamet to be tested on the public, they would have know how reliable and durable it would or would not been. As far as I can see, no successful 'accelerated life testing' was performed. If it had been, then DePuy would have broadcast the results.
2. If DePuy were largely depending on testing their hip on patients from 2002, then there'd be no valid answers available until at least 2004, when just over 1000 Pinnacle (not necessarily Ultamet) hips had been fitted. See below.
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The 311 Leigh Day Claimants wanted to use the UK National Joint Register's data to provide a way of comparing the Pinnacle MOM hip's performance with other hips being used at the time. DePuy argued that the advent of a new form of polyethylene hip bearing would make a performance comparison invalid.
In Paragraph 313 of her verdict, Mrs Justice Andrews wrote:
"If data relating to MoP hip prostheses includes both metal on conventional polyethylene and metal on cross-linked polyethylene or HXLPE articulations, as it undoubtedly does in the NJR database and in the SHAR 2014 report, it is likely to be less reliable for comparison purposes than if it relates to metal on conventional polyethylene alone. The whole purpose of the intentional cross-linking was to produce a harder wearing and more durable surface; if and to the extent that succeeded (as the short-term scientific information on its performance suggests that it has) one would expect data relating to the cross-linked product or products to improve the CRR even in the short-term. There was some debate at trial about whether the inclusion of HXLPE in the NJR data made a statistically appreciable difference to the CRR for MoP over 10 years. Bearing in mind all the non-statistical evidence, as well as the history leading to the development of the alternative harder bearing surfaces, one would expect the data to demonstrate metal on HXLPE articulations to have an appreciably better CRR than metal on conventional polyethylene."
Note: SHAR = Swedish Hip Arthroplasty Register, and CRR = The rate of hip prosthesis revision operations.
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