FDA cracks down on artificial hip-makers
Kai Ryssdal: Getting a hip replacement is a painful and increasingly common procedure. So, apparently, is having a problem with that new hip after you own it. The Food and Drug Administration is starting to pay more attention to defects in medical devices, like those hip replacements, after they’ve been approved for sale. And that has more than a dozen manufacturers under the microscope.
Marketplace’s Nancy Marshall Genzer reports.
Nancy Marshall Genzer: Imagine you get an all-metal hip replacement. The parts start rubbing together, releasing metal particles into your bloodstream. The FDA is hearing more and more complaints like this, so it’s ordered more than 20 metal hip manufacturers to study the problem and report back.
Jerry Katz: It is really unusual.
That’s health care consultant Jerry Katz. He says the hip replacement studies are unusual because the FDA normally does its toughest scrutiny of a product before it’s approved for use. At that point, the device is expected to work. But that’s not always the case. Look at pacemakers, says Katz.
Katz: Failure, recall. You know, and that’s a big deal.
Katz expects the FDA to tackle the pacemaker problems next. One of the agency’s lead scientists, Dr. William Maisel, won’t confirm that. But he says the FDA will soon require tracking devices on products like pacemakers.
William Maisel: We’ll be able to very specifically identify the model, the lot number, the manufacturing plant where a device was made.
Medical device manufacturers aren’t too enthusiastic about the additional scrutiny. David Nexon is the senior executive vice president of Advamed.
David Nexon: If there’s an issue, FDA needs to look at it; manufacturers understand that and support it. But you don’t want regulation that’s unnecessary or inappropriate or overly burdensome.
The FDA’s Maisel doesn’t want to limit access to products consumers need and are already using. But for now, the agency appears to be leaning toward more research, even after approval.
In Washington, I’m Nancy Marshall Genzer for Marketplace.
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