The FDA said today that it will require the manufacturers of metal-on-metal hip implants to put the devices through its stringent pre-market approval process.
The federal safety watchdog said its final order affects 2 types of MoM hips: Hip joint metal/metal semi-constrained with a cemented acetabular component, and hip joint metal/metal semi-constrained with an uncemented acetabular component. The devices, many of which have been recalled or otherwise pulled from the market, have been found to deliver failure rates as high as 43% after 9 years.
Metal-on-metal hip implants came under intense scrutiny following the high-profile August 2010 recall of DePuy Orthopaedics’ ASR XL acetabular and ASR hip resurfacing systems. Johnson & Johnson pulled the devices off the market after receiving reports that a higher-than-normal number of patients required surgeries to correct or remove defective implants.
Some reports warned that hundreds of thousands of patients may have also been exposed to toxic compounds from metal-on-metal implants, putting them at risk of developing cancer, cardiomyopathy, muscle and bone destruction and changes to their DNA. Since then the controversy has ensnared other device makers, with personal injury lawsuits piling up even against metal-on-metal implants that haven’t undergone a recall.
The FDA said its final order, due to issue tomorrow and published on its website today, requires metal-on-metal hip manufacturers to file PMA applications by May 18 if they want to keep their devices on the U.S. market. There are 5 companies with MoM hips on the market here, according to the agency; all 5 have had their plans for post-market studies approved.
“Given the known risks, the FDA believes that there is insufficient evidence and information to conclude that general controls in combination with special controls would provide reasonable assurance of the safety and effectiveness of these devices,” the FDA said.
Manufacturers must file PMA applications that include “any risks known, or that should be reasonably known,” the effectiveness of the device and “full reports of all non-clinical and clinical information from investigations on the safety and effectiveness” of the metal-on-metal devices, the FDA said.