There’s an interesting article in The New York Times about how in the U.S., there’s the rush to create the next great medical device or drug. And how we as consumers often mistake the latest for the greatest and end up suffering the consequences when a few years down the road it turns out that the “latest” has a lot of problems and/or unforeseen consequences that we would have known about had there not been this rush to get this “terrific” medical advance on the market.
Specifically, they talk about metal on metal hip replacements, the diabetes drug Avandia (linked to heart attack), and a component in a heart device made by Medtronic that was installed in 200,000 patients before they discovered it was prone to fracturing (the component, not the patient). Twelve people died as a result.
For the metal hip, it seems to work well in some instances – like if you’re a tall, middle aged man:
Some experts, like Dr. Malchau, said they used a special type of metal-on-metal implant known as a resurfacing device in specific patients — mainly taller, middle-age men — because data showed that they worked in that small group. But as with many innovations, metal hips were marketed to all comers. For example, about 65 percent of the implants went to women and older patients, according to an estimate by a consulting firm, Exponent Inc. As it turned out, those two groups appear most prone to failures involving the devices.
“The vast majority of the ‘innovations’ on which we have spent money with respect to orthopedics over the past two decades have not resulted in improved patient outcomes,” said Dr. Kevin J. Bozic, an orthopedic surgeon and professor at the University of California, San Francisco, who has written about artificial joints’ impact on health care costs.”
So what’s the issue with the metal on metal hip? Evidently in the “old” hip replacement design created in the 1960s, the ball joint was metal and the socket or cup in which it was inserted was plastic. In the new design (which actually isn’t that new — it’s been kicking around for about three decades), both parts are metal. The drawback with metal on metal is that over time, the ball rubbing on that metal socket shaves off little bits of metal which then enter the bloodstream and wind up lodged in people’s organs. There were concerns it might lead to cancer. From the Times:
By 1996, Jonathan Black, an industry consultant and professor emeritus of bioengineering at Clemson University, warned in a medical journal article that the metal-on-metal design posed significant risks because little was known about the biological havoc that metallic debris might cause. He also argued that given the high success rate of existing designs, it would be statistically impossible to run enough studies to prove the new implants’ supposed superiority.
At the time, Mr. Black estimates, the all-metal implants accounted for only a tiny fraction of some 250,000 hips implanted annually in the United States. By 2008, they were used in one out of every three hip procedures.
What happened? In essence, the old technology was repackaged as new and cutting-edge, and warnings like Mr. Black’s were ignored and considered no longer relevant. This new generation of devices was manufactured differently and reflected better designs, advocates argued.
Companies and surgeons began promoting the new implants as the next big step in orthopedics, one that would let patients, particularly middle-age ones, do strenuous physical activities because their mechanics were more natural. And patients, intrigued by ads featuring celebrity athletes, also wanted such devices.
One woman ended up with grey fluid around her hips. Her doctor, who had leapt on the “latest” technology and performed 40 metal-on-metal hip replacements, said “It has not been fun.” The metal debris has caused “crippling tissue and muscle damage and neurological issues in other patients.” One woman had a blood test and found she had a high level of metal ions. When they did an x-ray of her hip, they found there was a tumor growing around the replacement device. Yikes.
Of course the metal-on-plastic design has its drawbacks too. The articles says that the type of plastic used in some of those designs shed particles that then led to bone loss in some patients. Sigh. You can read the full article here.