McMinn laments that “design changes have sex appeal but history records
several major blunders,” and proceeds, with surgical precision, to
disembowel DePuy for its many missteps: an acetabular component (hip
cup) that is too thin and deformable, an undersized cup that will
concentrate too much force directly on the edge of the cup (which he
predicts will lead to early failure), a design that is too conforming (which
decreases the margin of error), and the manufacturing process of heat
treatment of metals that has been shown to increase wear. While often
acknowledging the impulses behind their individual design innovations,
McMinn predicts that, combined, the changes will doom the ASR implant
system to failure, particularly if the surgeon deviates at all from perfect
placement of the devices. In the end, with evangelical zeal, Derek McMinn
implores, “a major redesign is urgently required ... only this time back a
winner, and copy the Birmingham Hip precisely.”
In 2009, the National Joint Registry of England and Wales issued a
report of high revision rates following ASR hip replacement: 7.5 percent
at three years. In April 2010, the Medicines and Healthcare products
Regulatory Agency (MHRA, the United Kingdom’s FDA) issued a Medical
Device Alert, noting “a small number of patients implanted with [MoM]
hips develop progressive soft tissue reactions to the wear debris associated
with MoM articulations.” As now has become evident, surgeons were
communicating their concerns with DePuy, and in one famous case, Mr.
Antoni Nargol, a surgeon from the northeastern England town of Tees, was
told that other surgeons were not seeing the same failures he was. Nargol
testified that DePuy “told me there were no other problems.”^29
Until there were.
Facing an onslaught of registry data that showed high early implant
failures, and perhaps more important, an increase in negative scientific
presentations at closed-door orthopedic meetings that resulted in
plummeting sales of ASR hips, DePuy “decided in 2009 that it would be
discontinuing the ASR System as a result of declining demand.”^30 But is
wasn’t until August 26, 2010, that DePuy recalled the ASR, a full year
after internally deciding that the project was a bust, significant because
thousands more patients would receive an implant known to have flaws.
The economics of such a decision are monstrous. To recall a device, the
company is voluntarily waving a white flag and admitting that the device
is flawed and dangerous. The FDA classifies Class I recalls “a situation