Consumers Union has posted an ad in the online news source, Politico, Monday, May 21, asking “Should medical device makers be allowed to sell new devices based on manufacturer-recalled products – without ever having to prove that the safety flaws were fixed?”
Sounds like the answer should be a resounding ‘NO’ doesn’t it?
When defective ProteGen synthetic mesh was pulled from the market in 1999, that didn’t stop manufacturers from naming it as a predicate for many of the other synthetic transvaginal meshes on the market today. This is the safety loophole that Consumers Union in its Safe Patient Project would like to fix.
It’s all based on the 510(k) approval process that only requires manufacturers to name a predicate medical device that’s already being marketed in order to obtain FDA clearance to sell. No safety assurances required. And you don’t even have to fix the defective medical device before naming it as a predicate again and again.
This full-page ad is being launched at Congress gets ready to approve the medical device user fee act (MDUFA) which will double the amount industry pays for FDA reviews over the next five years. But industry wants something in exchange – quicker approvals and more industry oversight. Not exactly the picture the public has of our safety regulators?
Consumers Union wants the FDA to have the authority to just say ‘NO’ to the approval of a medical device when it is based on a defective predicate. Under present law, the FDA does not have that authority which cripples it in the area of patient protection; after all most Americans believe this should be the primary responsibility of the FDA.
“It’s time to close this absurd loophole and give the FDA the power it needs to protect patients,” says Consumers Union Safe Patient Project director Lisa McGiffert. She adds that the medical device lobby has blocked common sense reform and members of Congress rejected including patient safety language to MDUFA.
Consider the recent defective medical devices that have been allowed onto the market because of the 510(k) – synthetic transvaginal mesh, metal-on metal hip replacement, and recalled heart devices – all were passed based on being the “substantial equivalent” to a predicate device even if that predicate is defective. In fact more than 90 percent of medical devices are cleared through 510(k) which, unlike drug approvals, do not require assurances of safety.
Consumers Union is trying to raise awareness of this dangerous safety loophole. In the meantime- hope you do not need a medical device implant – it may just be good for industry but very bad for you.