September 26, 2017 Press Release
WASHINGTON, DC (September 26, 2017) —Congresswoman Rosa DeLauro (CT-03) released the following statement urging Congress to pass the Medical Device Safety Act, which would enhance legal protection for victims of unsafe medical devices. Currently, high risk device manufacturers are protected from being held liable at the state and local levels if their device has received premarket approval from the Food and Drug Administration (FDA).
”One of our government’s most important duties is to keep our people safe from harm, whether it is the food we eat, the medications we take, or the medical devices we use,” said DeLauro. “Too often, that basic mission is going unfulfilled at the FDA. Failure at the FDA has awful consequences, as faulty medical devices have tragically injured, or even killed, thousands of Americans across the country.
“Instead of serving as a steward for public safety, the FDA has put its stamp of approval on these potentially unsafe devices, with manufacturers’ bearing no legal risk when things go wrong,” continued DeLauro. “Even after the FDA knows that these devices put people at risk, it simply will not take them off the market. That is why Congress must immediately pass the Medical Device Safety Act, to arm American families with the necessary tools to hold these companies accountable once and for all. I will not let up in the fight—alongside my colleagues and consumer advocates—to get this life-saving legislation signed into law.”
“The health of thousands of women has been negatively affected by FDA’s lack of proper oversight, specifically with Essure,” said Amanda Rusmisell, Legislative Liaison for the Essure Problems Group. “This product not only impacts women’s quality of life, it also puts an enormous financial strain on them and their families. Despite FDA’s Black Box Warning on Essure and our pleas to take this product off the market, women are still in the dark about its potential dangers— such as hysterectomies, autoimmune diseases, additional surgeries, and life-threatening health effects. That is why the Medical Device Safety Act is so crucial. Women deserve to know about the dangers of this product, and if they are impacted by Essure, they must be able to take action.”
DeLauro is a senior member on the subcommittee responsible for funding the U.S. Food and Drug Administration.
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