Fix the Flaw!The medical-device safety bill is coming up for a major vote, and it still has a gaping loophole! Tell your Senators to Fix the Flaw!

You wouldn’t buy a new car with a known safety defect. You’d expect the problem to be fixed first.

So why is Congress planning to let medical device manufacturers keep selling implants – from hip replacements to heart defibrillators to surgical mesh – without having them fix the safety flaw first?

Tell your Senators and Representative: Fix the Flaw!

This week the Senate could vote on the bill that sets safety standards for the medical device industry. Lobbyists have managed to keep this gaping safety loophole from being fixed in the bill, and we need consumers to speak out today before it’s too late.

Manufacturers love the loophole because they can put an implant on the market just by showing that it’s ‘substantially equivalent’ to one already approved – even if the implant they’re modeling it on was recalled for safety problems! And the FDA can’t make the company prove they’ve fixed the flaw or do clinical safety testing before the device is sold to you!

The consequences are serious. Tens of thousands of women have various vaginal mesh implants inside them based on a 1999 recalled product. Last year the FDA warned about bleeding, infections and organ perforation from the mesh deteriorating, and many women require multiple surgeries to repair the damage. The FDA should have the authority to demand flaws like these be fixed before allowing the devices to be sold.

Congress: Fix the Flaw with medical devices, and hold industry responsible for safety!

It’s important you get your Senators’ attention on this matter, or the loophole might just slip quietly through. Consumers’ emails have already made the safety bills stronger, so please forward this to others so they can add their voice to this critical issue.

Sincerely,
Lisa McGiffert, SafePatientProject.org