Manufacturers of the mesh implants insist they have improved the design even though their products have been cleared by the FDA based simply on their similarity to devices with a history of safety problems. However, device makers were not required to show they had fixed the design flaw in order to get the FDA’s green light.
Congress must reauthorize the medical device statute this year and industry lobbyists are pushing lawmakers to resist efforts to strengthen federal oversight, even though our current system is clearly broken and leaves too many patients at risk.
We need stricter safety testing for medical implants and other high-risk devices, and the FDA needs better tools to monitor devices once they are on the market. And it’s time to give the FDA the authority to require manufacturers to prove they’ve fixed safety flaws when they base new devices on ones that have been recalled.
Medical device makers insist this reform isn’t necessary, but thousands of women harmed by defective vaginal mesh implants prove otherwise. It’s time for Congress to put patient safety first and close this indefensible loophole.
James A. Guest is president and CEO of Consumer Reports.
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