Is the FDA system broken? Manufacturers of hip implant medical devices don’t have to go through clinical trials like prescription drugs. All these metal on metal hip implant makers have to do is – to establish that the hip implant is substantially equivalent to other devices already on the market in order to gain approval.
That’s good news for the billion-dollar medical device makers and their investor relations but bad news for people like you who need hip replacements and the doctors who implant them. It doesn’t take much to get a hip replacement on the market. Does it practically take an act of God to get the device removed from the marketplace?
Something is terribly wrong when a dangerous medical devices like metal on metal hip implants are introduced and marketed over and over again with the same set of flaws and side effects or worse set of flaws and side effects.
According to a recent article in the New England Journal of Medicine, more than 500,000 patients in the United States have received metal-on-metal hip implants, most of which were implanted between 2003 and 2010. Unfortunately, there is now compelling evidence that these implants fail at a higher rate than hip implants made of other materials.
The metal-on-metal (MoM) hip has a failure rate of nearly 50% in six years.
In response to widespread public health concerns after hundreds of thousands of hip devices have been implanted, the FDA ordered manufacturers of metal-on-metal hip implants to conduct post-market surveillance studies. The order happened May 6, 2011. Why did the FDA wait so long to act?
Unfortunately, data from these studies which are funded by the hip implant manufacturers will not be available to protect you or future people needing hip replacements anytime soon. As previously stated the FDA’s 510(k) approval pathway is easier than a slam dunk but removal from the market requires an act of Congress.
Once again, corporate profits override public health concerns.