July 24, 2014 SIGN IN | REGISTER

Guest: Medical Device Provision Puts Patients at Risk

In 2011, the FDA warned doctors and patients that serious injuries associated with these implants are not uncommon. According to the FDA, the most frequent complications reported by patients include mesh erosion through the vagina, bleeding, infections, urinary problems and organ perforation. Many of these injuries require multiple surgeries to repair, and sometimes leave patients permanently disabled.

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 FDAís 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 itís time to give the FDA the authority to require manufacturers to prove theyíve fixed safety flaws when they base new devices on ones that have been recalled.

Medical device makers insist this reform isnít necessary, but thousands of women harmed by defective vaginal mesh implants prove otherwise. Itís 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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