In what could be a major move by the U.S. Food and Drug Administration, a recently proposed order that has now been released for public comment indicates the agency is finally considering requiring several varieties of all-metal hip implants to go through a more rigorous approval system.
In the FDA’s recently released proposed order, it has moved to close a gaping loophole in the system. The loophole dates back to the 1976 Medical Device Amendments, which first established a system for regulating medical devices in the U.S. The system divided medical devices into three groups: Class I for low-risk devices, Class II for moderate risk devices and Class III for high-risk devices.
Because there were already many medical devices on the market, legislators made a compromise with device manufactures: some of the Class III devices on the market already, those that were “preamendment” devices, could be reviewed under a much less rigorous 510(k) substantial equivalence approach. This saved the devices from the much more difficult premarket approval application (PMA), an approach which requires manufacturers to gather data from clinic trials to bolster their applications.
Even though the intention was for the compromise to eventually end, many high-risk Class III preamendment devices have continued to be allowed to operate in the 510(k) approval system. The problem that the FDA has increasingly become aware of is that some of these devices, specifically metal-on-metal hip implants, have since become the focus of safety concerns here in the U.S. and across the world. By continuing to allow such dangerous devices to be easily waived through the approval process, the FDA was failing to do its job to protect American consumers.
One great example is DePuy’s ASR Acetabular System. The hip implant was approved through the 510(k) process after the FDA said it was substantially equivalent to preamendment devices. The fact is, three aspects of the DePuy system were similar to previously approved devices, but all three of those aspects had never been present in any one approved device. Moreover, the three devices that DePuy used as predicate devices, the McKee-Farrar, Ring and Sivash all-metal hip prostheses were all designed before 1976 and have all since been discontinued due to their own high risks of revision surgeries.
The DePuy ASR would go on to be involved in a massive, worldwide recall due to high rates of revision surgery associated with the device as well as worries over metal shavings getting into patients’ bloodstreams. The episode means that the DePuy hip implant was cleared under the 510(k) system assuming it was based on previously cleared, safe devices, something that ultimately proved not to be true.
Thankfully, the FDA has realized the danger of the 510(k) approval process for risky, Class III devices. The proposed order, should it eventually be implemented, takes a critical step of requiring the filing of a much more rigorous premarket approval application (PMA) for all-metal hip joint devices, including those with or without a cemented acetabular component. This requirement would include the DePuy ASR and other similar devices. The public will have 90 days to submit comment on the proposed order before the order goes into effect.
As personal injury attorneys who have seen firsthand the dangerous repercussions of such devices, we can only hope the new FDA proposed order is implemented. About one million of these all-metal devices have been implanted in patients across the world over the past 15 years. This means that far too many patients are at possible risk of the dangerous effects of cobalt exposure. If you or someone you know have been injured by a defective product and you would like to discuss your case with an attorney, please contact the Georgia product liability litigation attorneys at Pope McGlamry P.C. today to schedule a free consultation.
See Our Related Blog Posts: