ASHES

  


Advocating Safety in Healthcare, E-Sisters

July 2018 Congressional Push for #MDSA17

With the Netflix release of The Bleeding Edge on Friday July 27, 2018, it is time for us to make another big push to Congress about The Medical Device Safety Act. (#MDSA17)


We sent out an email on Thursday the 26th announcing the documentary premiere and the announcement of Bayer halting the sale of Essure in the US, to all of our contacts in the House and Senate. Below you will find instructions on how to help:


If you have any questions or need any help doing this, please reach out to Amanda Rusmisell at rusmisell@att.net

1. Find out which Members of Congress are representing you in Washington:

                       a. Find your Representative in the House

                       b. Find your Senator in the Senate

2. From their website reach out to the office via phone or email

                       a. Please note: Congressman Brian Fitzpatrick, Congresswoman Rosa DeLauro, Congresswoman Jan                                        Schakowsky, and Congressman Peter DeFazio are all sponsors of the bill.

                           If they are your Representative, please reach out and thank them for supporting the bill.

                       b. Ask for the Health Aide either to have a phone conversation or send him/her an email

      Conversation:

                      Tell your story (2-3 minutes)
                      Request they watch the The Bleeding Edge on Netflix that will be released on July 27th
                      For Representatives ask for them to co-sponsor the Medical Device Safety Act of 2017 in the House (see email                       below for talking points)
              Email:
                      For a Representative, please ask them to co-sponsor the Medical Device Safety Act of 2017
                     (See sample email below)
                      For a Senator, please ask them to introduce the Medical Device Safety Act of 2017 into the Senate
                     (See sample email below)

3. Follow up regularly with the Health Aide. Reach out with news articles, updates on your health, updates on the FDA,               updates on court actions, etc.

To find your health aide click this link: http://capwiz.com/fconl/home/

Sample Email to your Representative:

SUBJECT: Medical Device Safety Act of 2017 (H.R. 2164)

Dear__________,


I am excited that The Bleeding Edge, a Netflix Original documentary from Academy Award nominated filmmakers Kirby Dick and Amy Ziering (The Invisible War, The Hunting Ground), premiered on July 27th! This documentary exposes the harm incurred by multiple patients resulting from four different medical devices covered by the 510k and Premarket Approval processes. The trailer for The Bleeding Edge was released by Netflix just last week.


(Feel free to personalize the email with your story here)


The documentary touches on the Essure Problems Group's work on the Medical Device Safety Act (H.R. 2164). As you may know, this bill was introduced in the house in April 2017, by Congressman Brian Fitzpatrick. It is a bipartisan bill co-sponsored by Congresswoman Rosa DeLauro, Congresswoman Jan Schakowsky, Congressman Peter DeFazio and the late Congresswoman Louise Slaughter. This 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, Essure and Mesh devices. 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 ruling in 2008, wherein the United States Supreme Court erroneously held that the preemption clause of the Medical Device Amendment essentially bars most 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.


On July 20th, just one week before the release of The Bleeding Edge, Bayer announced it will be halting all sales and distribution of Essure. This announcement was celebrated by me and thousands of E-Sisters worldwide. Although this was a satisfying victory,  there is still much work to be done. The Medical Device Safety Act of 2017 must be pushed through Congress!


I urge you to watch The Bleeding Edge and support me by co-sponsoring the Medical Device Safety Act (H.R. 2164) in the House. It’s time to take a bold stand for medical device post-market safety and accountability!


Thank you,

_____________________


Sample Email to your Senator:

SUBJECT: Medical Device Safety Act of 2017

Dear____________,


I am excited that The Bleeding Edge, a Netflix Original documentary from Academy Award nominated filmmakers Kirby Dick and Amy Ziering (The Invisible War, The Hunting Ground), premiered on July 27th! This documentary exposes the harm incurred by multiple patients resulting from four different medical devices covered by the 510k and Premarket Approval processes. The trailer for The Bleeding Edge was released by Netflix just last week.


(Feel free to personalize the email with your story here)


The documentary touches on the Essure Problems Group's work on the Medical Device Safety Act (H.R. 2164). As you may know, this bill was introduced in the house in April 2017, by Congressman Brian Fitzpatrick. It is a bipartisan bill co-sponsored by Congresswoman Rosa DeLauro, Congresswoman Jan Schakowsky, Congressman Peter DeFazio and the late Congresswoman Louise Slaughter. This 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, Essure and Mesh devices. 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 ruling in 2008, wherein the United States Supreme Court erroneously held that the preemption clause of the Medical Device Amendment essentially bars most 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.


On July 20th, just one week before the release of The Bleeding Edge, Bayer announced it will be halting all sales and distribution of Essure. This announcement was celebrated by me and thousands of E-Sisters worldwide. Although this was a satisfying victory,  there is still much work to be done. The Medical Device Safety Act of 2017 must be pushed through Congress!


I urge you to watch The Bleeding Edge and support me by introducing the Medical Device Safety Act (H.R. 2164) in the Senate. It’s time to take a bold stand for medical device post-market safety and accountability!


Thank you,

___________________________