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ASHES Pushes Congress for Medical Device Safety Act

Holly Kelly Ennis May 10, 2019

On Wednesday, May 15th and Thursday May 16th, patient activists harmed by medical devices (Breast Implants, Essure, Hip Implants, and Mesh), along with Madris Tomes of Device Events, and attorney Holly Ennis of Ennis & Ennis, will be lobbying in Washington, DC. The Medical Device Problems Action Campaign will be meeting with Members of Congress to garner support for The Medical Device Safety Act.

The Medical Device Safety Act will simply amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting all Class III devices. This bill will restore a patient's rights to seek restitution if harmed or killed by a medical device.
Initially introduced on April 26, 2017, the bipartisan Medical Device Safety Act was reintroduced on May 10th, 2019 by Congresswoman Rosa DeLauro (CT-3). Congressman Brian Fitzpatrick (PA-1), Congresswoman Jan Schakowsky (IL-9), Congressman Peter DeFazio (OR-4), Congressman Bobby Rush (IL-1), and Congressman Lloyd Doggett (TX-35)

There are currently more than 150 Class III medical devices on the market protected by preemption. Preemption significantly protects the manufacturers of these devices from liability, even if the medical device is found to be defective, dangerous, ineffective, or it has been recalled or withdrawn from the market.

We must restore the consumers’ rights. One in ten Americans will have a medical device implanted in their lifetime. If a patient has an adverse event from a medical device, and is injured or killed, they should be able to hold the manufacturer accountable. Medical bills, lost wages, and permanent disability can destroy a person's quality of life and put a huge strain on an individual and their family. Often times it takes legal action to put the pressure on the manufacturer to recall or remove a device from the market, and help those who were harmed. Without that accountability, the manufacturer has no incentive to withdraw a device from the market that may be harming tens of thousands of people. The FDA ultimately leaves it in the hands of the manufacturer to recall or withdraw unsafe medical devices, therefore consumers must have the right to legal action to ensure manufacturers are being accountable. 

The Medical Device Safety Act will restore and balance the scales of justice and allow the people to hold device manufacturers accountable to a higher standard of care. We want safe and effective medical devices. No legal protection blanket should ever overshadow the voice of a large group of injured citizens. Please help support these patient advocates who are working tirelessly for you and your rights. You can donate online at or at

For statements and media inquiries, contact the Medical Device Problems Group at