A medical-device safety bill is coming up for a major vote that includes a gaping safety loophole that industry lobbyists just love.
It allows manufacturers to put an implant on the market just by showing it's "substantially" similar to one already approved -- even if the implant they're modeling it on was recalled for safety problems! And the FDA can't make them prove they've fixed the flaw, nor do safety testing, before it's sold to you!
Would you want something as important as a defibrillator or hip replacement put in you or a loved one if it was based on a recalled product? Tell your Senators and Representative to Fix the Flaw!
Subject: MDUFA: Fix the Flaw!
Dear [Decision Maker],
You wouldn't expect me to buy a car if it was modeled after one with a known safety problem. Yet the Medical Device User Fee Act you will soon vote on will allow manufacturers to sell me medical implants that are modeled after others that have been recalled for safety reasons! I urge you to Fix the Flaw, and support an amendment to take this loophole out of the MDUFA bill.
[Your personal comments will be added here.]
This loophole lets a manufacturer put a medical device or implant on the market just by showing that it's 'substantially equivalent' to one already approved -- even if the product it's based on was recalled. Worse, the FDA can't make the company prove they've fixed the flaw, or do clinical safety testing, before it's sold to me or my family!
This loophole not only puts lives at stake, it's also a costly public health issue.
Tens of thousands of women have various vaginal mesh implants inside them based on a 1999 recalled product. After receiving a wave of complaints, the FDA last year warned doctors and patients about bleeding, infections and organ perforation from the mesh deteriorating. Many women require multiple, costly surgeries to repair the damage, and end up suffering debilitating injuries.
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