Advocating Safety in Healthcare, E-Sisters

Medical Device Safety Act

Aims To Restore Rights

To Patients Harmed


September 13, 2017

On September 25, 2017, ASHES nonprofit will be hosting a rally from 9:00am to 5:00pm in Washington D.C. in support of the Medical Device Safety Act. Administrators of the Essure Problems Group and the Breast Implant Victim Advocacy Group have organized the event. The rally will take place on Capitol Hill Grounds, Demonstration Area 9Constitution Ave NE and 1st St. The group will be wearing red shirts to show solidarity and support for the bill. At 4pm that day, the coalition will come together with the co-sponsors of the bill, The Medical Device Safety Act H.R. 2164for a congressional press conference in room 2358-C Rayburn House Office Building.

The Medical Device Safety Act was introduced in the house on April 26, 2017 by Congressman Brian Fitzpatrick. It is a bi-partisan bill currently co-sponsored by Congresswoman Rosa DeLauro, Congresswoman Louise Slaughter, and Congresswoman Jan Schakowsky. The bill would amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting all Class III devices, including, but not limited to, the essure device, hip implants, pacemakers, surgical mesh, defibrillators, nerve stimulators, and breast implants.

There are over 157 Class III medical devices on the market in the USA. Manufacturers of Class III medical devices currently enjoy federal preemption protection. This is due to the Riegel vs Medtronic supreme court ruling in 2008, when a United States Supreme Court case held that the preemption clause of the Medical Device Amendment bars state common-law claims that challenge the effectiveness or safety of a medical device marketed in a form that received premarket approval (PMA) from the Food and Drug Administration.

What does this mean for consumers? It means that patients who are harmed by Class III medical devices have a very difficult, if not impossible, time pursuing legal recourse if harmed, disabled, or killed by a Class III medical device. The manufacturers are, in essence, protected.

We are asking patients, their loved ones, friends and family members, who have been negatively impacted by a Class III medical device, to help raise awareness and support the bill. We are also asking members of Congress to support this bill and consider becoming a co-sponsor. The purpose of this bill is to restore a patient’s rights should he/she be harmed. We all deserve the same rights as consumers.