Many blame the fact that all of these MoM devices were approved by the FDA over the years under the 510(k) process. It presumes that a new device that is very similar to an approved device, does not need to undergo rigorous safety testing, since the device it is being compared to, has already passed those tests The 510(k) essentially gave such devices a free ride.
In February, 2011, the FDA launched a MoM Hip Implant System website, which emphasizes some symptoms patients and their doctors should look out for, including ion toxicity in the blood from cadmium or cobalt particles resulting from metal contact with bone.
"At this time, it is not possible to know who will experience a reaction, what type of reaction they might have, when the reaction will occur, or how severe the reaction will be. However, it is known that over time, the metal particles around some implants can cause damage to bone and/or tissue surrounding the implant and joint," the FDA website says.
David Langton, an orthopedic surgery resident at University Hospital in North Tees, Great Britain, has focused on MoM device research for the last four years and believes MoM devices of all types have been an "an absolute disaster," with failure rates or required revisions in far more than 12%-13%.
His research discovered revision surgeries required in 49% of patients, many of whom experienced toxicity from excessively high levels of cobalt and cadmium in their blood.
"The 49% failure rate...we expect will be 80% in eight years, and there are three other [centers] in the UK which have quoted similar figures at meetings," Langton wrote in an e-mail Wednesday.