ASHES 

Advocating Safety in Healthcare E-Sisters

If you have any questions or need any help doing this, please reach out to Amanda Rusmisell at 

rusmisell@att.net or 704-968-5824

1. Find out which Members of Congress are representing you in Washington:
   • Find your Representative in the House
   • Find your Senator in the Senate
2. From their website reach out to the office via phone or email
   1. Please note: Congressman Brian Fitzpatrick, Congresswoman Rosa DeLauro, Congresswoman Jan Schakowsky, Congressman Peter DeFazio, Congressman Bobby Rush and Congressman Lloyd Doggett have all committed to sponsoring the bill. If they are your Representative, please reach out and thank them for supporting the bill.
   2. Ask for the Health Aide either to have a phone conversation or send him/her an email. You may find the Members of Congress Health Aide listed at this link (http://capwiz.com/fconl/home/ ), but please double check with the office as this information is not updated regularly.

If you have a conversation:

- Tell your story (2-3 minute)

- Request they watch the The Bleeding Edge on Netflix

- For Representatives, please ask for them to co-sponsor the Medical Device Safety Act in the House

- For Senators, please ask them to introduce the Medical Device Safety Act into the Senate in May

If you send an email:

- For a Representative, please ask them to co-sponsor the Medical Device Safety Act (See sample below)

- For a Senator, please ask them to introduce the Medical Device Safety Act of 2019 into the Senate (See sample below)

For Members of the House

SUBJECT: Medical Device Safety Act H.R.2669

Dear__________,

I am reaching out regarding the Medical Device Safety Act of 2017 (H.R. 2669). This bill was reintroduced on May 10, 2019. I would like to talk with you to see if the Congressman/Congresswoman would be interested in co-sponsoring this important bill. The current bill is identical to the Medical Device Safety Act of 2009 (H.R. 1346) that many members of the House co-sponsored in 2009.  

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

As you may know, this bipartisan bill was introduced in the house on May 10, 2019, by Congresswoman Rosa DeLauro, Congresswoman Jan Schakowsky, and Congressman Brian Fitzpatrick. It is a bipartisan bill. 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, implantable pacemakers 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 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.

For a bit of background, I would suggest watching The Bleeding Edge documentary on Netflix. This documentary will give you a good understanding about how medical devices are approved through the FDA (510k and PMA process), a good background on how consumers are being impacted and background on the Essure Problems Group. Also, the International Consortium of Investigative Journalist released their latest investigative reports last November called the Implant Files. This had a huge impact on the FDA's decision to change the way they approved medical devices under the 510k products, as reported in this AP story.

After you read over this information, please do not hesitate to reach out with any questions you may have. I look forward to chatting with you about the possibility of the Congressman/Congresswoman co-sponsoring the Medical Device Safety Act. It’s time to take a bold stand for medical device post-market safety and accountability!

Thank you,
_____________________

For Members of the Senate

SUBJECT: Medical Device Safety Act H.R.2669

Dear__________,

I am reaching out regarding the Medical Device Safety Act of 2017 (H.R. 2669). This bill was reintroduced in the House on May 10, 2019 and we are looking for a companion bill to be introduced in the Senate at the same time. I would like to talk with you to see if the Senator would be interested in in introducing this important bill. The current bill is identical to the Medical Device Safety Act of 2009 (S. 540) that many Senators backed in 2009.

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

As you may know, this bipartisan bill was introduced in the house on May 10, 2019 by Congresswoman Rosa DeLauro, Congresswoman Jan Schackowsky, and Congressman Brian Fitzpatrick. It is a bipartisan bill. 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, implantable pacemakers 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 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.

For a bit of background, I would suggest watching The Bleeding Edge documentary on Netflix. This documentary will give you a good understanding about how medical devices are approved through the FDA (510k and PMA process), a good background on how consumers are being impacted and background on the Essure Problems Group. Also, the International Consortium of Investigative Journalist released their latest investigative reports in late November called the Implant Files. This had a huge impact on the FDA's decision to change the way they approved medical devices under the 510k products, as reported in this AP story.

After you read over this information, please do not hesitate to reach out with any questions you may have. I look forward to chatting with you about the possibility of the Senator sponsoring a companion bill to the Medical Device Safety Act in the Senate. It’s time to take a bold stand for medical device post-market safety and accountability!


Thank you,

_____________________