We’ve heard about them, cardiac stents that fail, surgical mesh for holding organs in place failing as well. Not to mention the horrifying news about the breast implants leaking gel in France that may have caused cancer in some.
Long known for identifying the safest cars, the best cribs, even the right eggs to buy, Consumers Union – the policy and advocacy arm of Consumer Reports – is now warning that a dangerous medical device loophole puts patients at risk, and proves once again that sometimes, maybe even often, money wins over common sense.
The shocking reality is that more than 90 percent of medical devices do not require clinical testing before the FDA clears them for sale. Instead, the FDA clears these devices through its fast track 510(k) process based on whether they are "substantially equivalent" to devices that are already on the market.
According to an AP story at Medical Technology Design, Consumers Union published a full-page print ad in Politico this week, just in time for Senate to vote on a bill this week to reauthorize the statute governing medical device oversight.
It seems hard to believe, but, as the ad notes, “the FDA does not have the power under current law to require device makers to prove they have fixed design flaws when they want to sell a new device based on one that has been recalled by manufacturers for safety problems,” the AP reports.
Who’s brain dead here? Consumers Union has urged lawmakers to give the FDA “the authority to require device makers to demonstrate that the safety flaws have been corrected in the new device.”
As someone who required a medical device after cancer surgery, all of a sudden I’m worried. Who knows if what’s in my body is someday going to affect me or my immune system in a deadly way? We all assume that anything our doctors prescribe for us – whether it’s medicine or hip replacements – is safe and has gone through all necessary tests. But the sad, dark secret is that this is not the case.
"It's time to close this absurd loophole and give the FDA the power it needs to protect patients," Lisa McGiffert, director of Consumers Union's Safe Patient Project, told the AP.
"The politically powerful medical device lobby has blocked this common sense reform. Medical device makers should have no objection to proving they have fixed safety flaws in order to sell products based on ones that are dangerous to patients,” McGiffert said. What’s their defense? According to the AP, as reported at Medical Technology Design, the medical device industry claims that the FDA has the authority it needs to address this problem.
But Dr. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, has confirmed to the AP and other media that the agency does not indeed have the power it needs to prevent device makers from repeating safety flaws when new devices are cleared, based on their similarity to ones recalled by manufacturers, according to the story.
The AP story points out that, while the Senate and House bills being considered this month include some important reforms, “both bills are missing critical measures needed to protect patients. Neither bill closes this loophole.”
The FDA isn’t totally sitting back. The organization announced last month that it is now working on a bar code system to track medical device failures. And last year it even offered consumers a way to check whether their eggs or salad lettuce or bicycles had been recalled.
The consequences of flawed medical devices, as we all know, can be tragic and heart-breaking to patients. The best known example of this dangerous problem involves vaginal mesh implants, used to treat urinary incontinence and weak pelvic organs in women. Johnson & Johnson sold these damaging implants for three years – that’s years, not months – without regulatory approval.
Consumers Union's ad also points out that the loophole would allow device makers to get new hip implants and defibrillators cleared for market based on similar models that have been recalled in recent years for safety reasons. Under current law, the FDA cannot require manufacturers to prove that the new device corrects the safety flaw of the recalled one.
Edited by
Brooke Neuman
