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 that sends electrical impulses to and from the heart to a pacemaker or defib device, proved to be defective. A thinner lead than what was already out there at the time, the lead was favored by doctors for the ease in which they could work with the new, thinner lead. 

But the lead was prone to crack. Cracks can affect electrical impulses, with sometimes-dire consequences. Here’s the problem: once a lead is connected to heart muscle, it is designed to stay there. Surgeons noted that removing a defective lead carries high risk to the heart and to the patient—thus, best to allow for a lead to actually fail, rather than assume a problem and risk certain injury or even death by attempting to remove a lead that my be functioning normally. 

Here again, is an example of a new device escaping pre-market testing, because it was substantially similar to an existing product already on the market. 

Imagine the pain and frustration patients with defective hips have been experiencing at the hands of problematic devices? Consider that such a setback might have been totally avoided, had the devices been properly tested before they were brought to market? 

The FDA needs to open its eyes, shed any undue influence that comes via the lobbying corridor, put the welfare of patients at the forefront and act accordingly by rescinding the fast-track carrot and require rigorous testing of every new product. 

Just because a product is similar, it may not behave in a similar fashion if manufacturing processes, materials and design, are different. The FDA has ample proof of this. 

Friday’s communiqué to hip manufacturers is the first baby step of a longer journey, that really needs to happen for the benefit of the American people.

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

This was posted on Monday, May 16th, 2011 at 3:19 pm and is filed under Drugs/Medical . Feel free to respond, or trackback. Read our comments policy.