“If something seems too good to be true, it probably is.”
When metal-on-metal hip replacement implants were first introduced into the market, manufacturers claimed these state-of-the-art devices would revolutionize the joint replacement industry by providing thousands of individuals suffering from chronic hip deterioration with a permanent, or at the very least, a long-term cure. Manufacturers marketed the cutting-edge metal-on-metal hip implants by targeting young, active people, promising that the latest design would last 20 years or more and provide them with increased mobility. The promise that the metal-on-metal hip devices would transform and change lives turned out to be true—these hips have only served to grossly exacerbate suffering. Unfortunately, the old adage, “If something seems too good to be true, it probably is,” applies to the now recalled DePuy ASR hip implants.
In August 2010, a massive recall of the DePuy ASR hip implants was issued. Since that time, orthopedic surgeons, patients, journalists, lawyers, medical experts, manufacturers and the FDA have all weighed in on what exactly went wrong and who is to blame. All of this finger pointing has resulted in lawsuits, Senate hearings, mandated medical studies, newly created joint registries, and extensive media coverage. Most importantly, it has led to painful and debilitating consequences for the 37,000 Americans who received the state—of—the—art devices.
Under the guise of “making things right,” DePuy has hired a third-party claims adjuster to reach out to those implanted with the defective devices and offered to cover all “reasonable and customary” costs associated with treatment. This past week, the FDA ordered 21 hip implant manufacturers to conduct post-market studies to determine failure rates. Although these remedial measures are more than appropriate in light of the devastating consequences facing those with recalled implants still inside their bodies, the core question remaining is how was this allowed to happen? Clearly, DePuy, who manufactured and marketed the devices without properly testing them, is to blame. Through a calculated and targeted effort, all DePuy had to do to get its metal-on-metal devices on the market was to employ the FDA’s fast-tracking 510(k) process, which only requires that the manufacturer show that its medical device is substantially similar to devices available on the market. Through this expedited process, manufacturers are able to bypass pre-trial testing and FDA inspection.
What have we learned from this catastrophic breakdown? Instead of running marathons with their new state-of-the-art hips, recipients are using canes and crutches to walk. Instead of a yearly physical, recipients are visiting the doctor every six months to have their blood tested for metal toxicity.