Word of the problem with hip implants made by DePuy Orthopaedics continues to spread, as ABC News recently reported again on the recall developments.
The investigators talked with one patient who had the recalled device implanted. Only five months after the implant she recalls suffering from severe pain. She explains of the problem, “I’m angry…patients or consumer rely on our doctors, we rely on the products that they use.”
As we’ve previously reported, the problem with the DePuy product was uncovered earlier this year, prompting the official recall in August. However, complaints about the devices go back to 2005. Nearly 100,000 patients received the specific metal-on-metal implant in question in the six years it was used. At least 12,000 of those patients will likely face severe complications as the device fails, requiring corrective surgery. Many of those patients may not be aware of their risk.
The failure of the devices caused metallic particles to be released in patient bodies. The particles then may enter the bloodstream ultimately risking a range of problems from deafness and dementia to heart failure. The consequences cannot be overstated.
New investigations into the cause of the problem are shedding light on the troubling reality of the product and its regulation. For one thing, the device was cleared by the Food and Drug Administration without any clinical trials to test its safety. This was made possible by a little known regulation that allows short-cutting the regulations if a new device is substantially similar to one already in use. In addition, no medical registry exists to track the performance of these medical devices. In that way, it is often difficult to uncover patterns of failure and complications. The delay in uncovering problematic devices means s that more patients receive the product before it is finally pulled.