Posts Tagged ‘ metal-on-metal hip ’

FDA & Post-Market Testing of Hip Devices: Too Little, Too Late

May 16th, 2011. By Hunter West

The requirement by the FDA for post-market testing on metal-on-metal hips is a sign that the federal regulator may be finally coming to its senses over the longstanding invitation to manufacturers to escape the road of rigorous testing for some medical devices. 

It’s about bloody time. 

The FDA is both a regulatory body and a political body, with the majority of its power reserved for manufacturers of new drugs and new medical devices. To that end the FDA can play hardball and make a manufacturer jump through hoops until the agency is satisfied that a device or drug delivers more benefit than it does risk. 

Once a device is on the market however, the FDA has pretty weak powers. A letter, such as the one sent to about 20 manufacturers of metal-on-metal hips on Friday, is about the extent of the FDA’s post-market authority. 

Basically, the FDA has ordered all artificial hip manufacturers to conduct post-market testing of their devices, in light of the failure rate of various artificial hips. 

However, had this testing been conducted in the first place, hundreds if not thousands of patients with problematic hips would have been spared the pain and frustration that comes with having an allegedly defective hip placed inside your body—at great expense—only to have it fail within five years of an expected 15 to 20-year lifespan. 

A failed artificial hip needs, in most cases, to be replaced—along with more pain, more downtime, and more money. 

At least it can be replaced… 

Witness the situation over heart leads a few years ago. One brand of defibrillator lead, a wire Read the rest of this entry »

Tags: Defective hip replacement, FDA, hip implant, hip surgery, metal-on-metal hip
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