Following a massive failure of all-metal hip implants that has affected thousands of patients, the Food and Drug Administration (FDA) is seeking to toughen regulations for manufacturers of these types of devices, according to the New York Times. Under the new regulations, metal-on-metal artificial hip makers would be forced to stop selling existing implants without first proving their safety and effectiveness.
A significant number of these all-metal devices have been failing after only 2 to 3 years after the initial surgery (a far cry from the 15-year expected lifespan of plastic-and-metal hips) causing already pain-wracked patients to endure excruciating second or third surgeries to replace the hip.
Now wait a minute, you’re saying. Doesn’t the FDA already make manufacturers prove the safety and effectiveness of medical devices before putting them on the market?
Yes, they do. But the standard of proof varies, depending on the device. And all-metal hip implants aren’t currently subject to the highest standard of proof, thanks to a loophole in the law that dates back to 1976.
As the Times article reports, in 1976, a law called the “Medical Device Amendment” was passed. This law established different test criteria for assorted medical devices, depending on the level of risk the device posed to the patient.
Makers of “high risk” devices were required to perform clinical trials to obtain FDA approval to market their product. Manufacturers of “moderate-risk” devices only had to show the FDA that their product was substantially similar to products already on the market.
All-metal artificial hips were already on the market in 1976 and it wasn’t clear to regulators whether they were high or moderate risk. So, as a temporary solution they decided to classify them as “moderate risk” until they figured out which level of risk they actually were. But no one ever did. Thus, subsequent makers of most all-metal hip implants never had to produce clinical data proving their safety and effectiveness.
With their recent announcement, the FDA is suggesting that it is finally ready to classify metal-on-metal hip implants as “high risk”. Or at least that these devices should be subject to the same testing criteria of other “high risk” products. And just think – it only took 37 years and the pain and suffering of thousands of hip implant patients to do it!
So, what do these new regulations mean for patients facing hip replacement in the near future? Not much.
Washington moves at a snail’s pace and according to the Times article, it’ll probably take a year for the rules to be finalized. After that, manufacturers will have 90 days to submit clinical data proving their device’s safety and effectiveness.
On the bright side, the disastrous failure of these hip implants has received so much attention, that doctors and patients alike are forewarned against using these devices. The Times article states that a few years ago, all-metal hips were used in 33% of all hip replacement surgeries; today, they are only used in about 5%.
If you or a loved one is expected to receive an artificial hip within the next year, be sure to thoroughly question your doctor about the type of implant used before agreeing to the surgery. In particular ask:
- Is the implant all-metal?
- Has it been run in clinical trials?
- How long is it expected to last?
- What are the risks involved in having this type of implant?
- Why is this type of implant right for me?
Stay informed and vigilant!