…In some patients, the hip implants failed just a few years after surgery, forcing them to underg a second round of costly and painful replacement operations.
About 12 to 13 percent of patients needed a second hip replacement after the ARS devices failed, the statement from DePuy said, citing new unpublished data from a national registry in Britain. Previously reported follow-up data, including internal company information and clinical trials, had reported lower rates of second hip-replacement comparable to similar devices by other companies, the statement said.
Given that business executives would rather vote for Dennis Kucinich than willingly recall a product, I’m guessing the previously unpublished data is completely accurate, possibly even understating matters.
Now, it’s possible to view this as an isolated case about a particular company and a particular product made by that company: but in truth artificial joints are, like the rest of the health care system, completely screwed up. Did you see how it was Britain’s data from its registry that ended up being cited? Really, there’s no reason that American data can’t augment that store of data—while more data isn’t always better, I can’t think of a good reason why more data in terms of artificial joints would be particularly misleading. And, make no mistake, the U.S. is behind. The Swedes started up the first registry, as far as I can tell, and the Australians followed suit next, with various other countries doing their own efforts; only the most innovative have done it over here:
In this country, Kaiser Permanente has used its registry in a variety of ways, said Dr. Donald Fithian, who helps direct that program. Seeing failures in one type of knee procedure, it discovered that most involved doctors new to it, so there is now greater supervision.
While that’s cool, there’s no wide adoption of the system with all of its virtues—which leads to companies selling products in the U.S. that have failed abroad, or leads to hospitals doing procedures in the wrong way. And when artificial joints don’t work out—they’re supposed to last fifteen years and sometimes last as long as two—the makers don’t have to pay a warranty, meaning that they’re indifferent at best, hoping for failure at worst, as to the eventual success or failure of their product:
The million or so artificial hips and knees implanted each year in the United States, they say, are normally not guaranteed. Instead, the costs of replacing implants that fail early because of design or mechanical problems — devices that sell for as much as $15,000 each — are largely paid by Medicare, insurance companies and patients.
Implants can fail for many reasons, but if only a small percentage of them fail prematurely because they are substandard, the costs to taxpayers, policyholders and patients can run into the tens of millions of dollars each year, health care experts estimate.
Orthopedic producers may sometimes even profit from the failures because they sell the replacements at full price.
“Companies have dumped these costs into the health care system,” said Dr. Lawrence D. Dorr, an orthopedic surgeon in Los Angeles who two years ago took the unusual step of drawing attention to one problematic hip device. “They don’t have any skin in the game.”
So, given the state of these incentives—is it any wonder DuPuy had to recall its artificial knees?