The costs related to defective all-metal hip implants is adding up, according to medical and legal experts. The popular devices were originally believed to extend the time patients could reasonably utilize a device; however, high failure rates, recalls, and other adverse health reactions have impacted thousands of patients worldwide.
A recent New York Times report described the broad issue—involving a number of different devices—as “the most widespread medial implant failure in decades,” with patients suffering painful reactions and requiring complex surgery to remove defective devices and undergo premature implantation with different devices.
The debacle could end up costing billions to taxpayers, insurance companies, and employers, which many fear will add to the burgeoning cost of health care that is already causing economic problems and is particularly complex given the number of device makers involved.
Metal-on-metal devices, such as the one used in this case, are failing within a few years, not the 15 or so years they have been touted to last and which is what their predecessors, which were not all metal, lasted, noted The Times. At last count, said The Times, the number of lawsuits and complaints filed against involved device makers exceeded 5,000. Insurers have advised patients that they intend to recover their costs from settlements patients receive; Medicare also is expected to recover its costs.
Prior to news breaking about the issues with all-metal implants, the devices accounted to almost one-third of the 250,000 hip implants performed annually in the United States, said The Times.
In addition to unexpectedly high revision rates—the rates in which hip device implants required removal and a new device implanted—another study raised questions about the benefits of newer hip and knee replacement devices, including metal-on-metal hip implants. According to a prior report in The Times, the study, based on data from Australia’s orthopedic registry, showed that not one artificial hip or knee introduced over a recent five-year period was any more durable than older ones. What’s more, close to 30 percent of the new devices performed poorly compared to older implant models.
In one case, a 55-year-old man underwent hip replacement with a defective artificial hip that failed. Soon after, his pelvis fractured, he suffered for months with no hip, he underwent a significant infection, and was saddled with massive medical bills that he said were “five times as much” as he paid for his home, said The Times.
In the U.S., no figures are available since this country does not maintain a similar database registry; however, just last month, a study of hip implants commissioned by the U.S. Food and Drug Administration (FDA) found that new versions, including all-metal designs, offered no benefits over older implants. It also found that people who received all-metal hip implants were more likely to require repeat surgery than those who received traditional implants.
It is believed that metal-on-metal hip implants can shed dangerous amounts of cobalt and chromium through wear, leading to tissue damage, premature device failure, the need for revision surgery, and even long-term health problems. In May, the FDA directed 21 makers of all-metal hip implants, including DePuy, Zimmer, Stryker, Biomet and Wright Medical, to conduct post-market studies of their devices to determine if they were shedding dangerous amounts of metallic debris in patients. DePuy alone has been hit with over 560 lawsuits over its Pinnacle devices; it faces another 3,500 lawsuits over issues with its recalled ASR device.
Meanwhile, wrote The Times, patients complain of debilitating, crushing medical bills; lost work; pain; long-term health effects; and the inability to lead productive lives. In some cases, device makers have covered some expenses for revision surgery; however, patients talk of being left with thousands of dollars in bills for devices that failed and left them saddled in wheel chairs.