Abstract
My involvement in the DEFENSE side of MoM hip litigation has allowed me the luxury of reflection and continued study of the basic and clinical science and voluminous medical and scientific literature concerning this particular wear couple. Much of what I have learned is relevant to other articular couples, and might help you in your next THR.
While useful, in vitro laboratory testing cannot wholly replicate or predict in vivo behavior of a particular wear couple. (Mother Nature always has something new to teach us!)
Although MoM implants underwent rigorous pre-market testing and evaluation by the industry and appropriate regulatory approval in both the US and EU, the process cannot assure the clinical safety or success of new designs and materials for all implant recipients.
Two year results obtained in pre-market (IDE) studies are of insufficient follow-up for accurate evaluation of the short, and certainly medium, or long-term clinical performance of new materials or designs, as demonstrated by the two year data from the Australian Joint Registry.
In certain populations, MoM bearings have performed satisfactorily (to date) in individuals for whom traditional bearings were a poor option.
Conclusions
Be conservative. Use appropriate clinical judgment and careful informed consent if you recommend new designs or materials to your patient.
