On May 15 and 16, 2019, ASHES board members along with other patient advocates harmed by Essure, Mesh, and Breast Implants, gathered in Washington DC to lobby Congress. We were there to ask for support of The Medical Device Safety Act of 2019. Introduced in the House on May 10th, we were seeking more co-sponsors in the house, and seeking a companion bill to be introduced in the Senate. We felt there was a lot of awareness of medical device issues this trip, and could feel a shift in support of our efforts. We hope to see this bill passed soon! Please ask your reps to support #MDSA19 by signing this petition to congress.
November 28, 2018 Lisa Saenz was a panelist for the Minority Pre-Health medical students club.
Q&A discussion was about student life, mental health and how to identify others needing help. Students were engaged and eager to participate in dialogue. #MentalHealth #SafetyinHealthcare
On November 15, 2018, Holly Ennis and Amanda Dykeman had the opportunity to present at a public meeting sponsored by the FDA's Patient Advisory Committee. The meeting was to establish dialogue between the FDA, Industry and Patients regarding how the FDA can utilize patient driven platforms and social media to better engage patients and to assist the FDA in analyzing real world data.
It was apparent everyone who attended has the same goal in mind, patient safety. Medical device safety and medication side effect awareness is essential in today’s environment. The other presenter’s discussed their practices of holistic treatment and concerns with the current culture of medication treatment versus problem focused.
Listen in on this episode of The Compassionate Achiever podcast, as they interview Angie Firmalino about her involvement in the Netflix documentary The Bleeding Edge, the group Essure Problems, the nonprofit ASHES, and also the website Medical Device Problems. She explains the progression of these entities and how they've evolved and came to be over the past seven years.
Episode - The Bleeding Edge:
Soundcloud - https://soundcloud.com/user-84194684/the-bleeding-edge-s3-e7
Social Media & Web:
On April 2, 2015, three administrators and two doctors met with 30 members of the FDA. We had one hour to present information pertaining to Essure. Dr. Diana Zuckerman, president of the National Center for Health Research, led our side of the presentation. She introduced Kim Hudak, a clinical trial participant, who claims Conceptus, original manufacturer of Essure, altered her patient records before submitting them to the FDA. Next to speak was Dr. Shawn Tassone, OBGYN. He spoke about his experience as a doctor who used to insert this device, but later decided that the problems associated with it were not worth the risks after finding out one of his patients had become pregnant. Angie Firmalino spoke of her own experience after getting Essure in 2009, and how she created the Essure Problems Facebook group, and the experience of running that support group. Angela Lynch Desa described the many women who come to our page seeking help, amongst those women, two who are in current trials of the new version of Essure, ESS505. Dr. Zuckerman asked questions of the FDA, about who could be of help to those women, and what can the agency do to follow up with the allegations about altered clinical trial information. The group then followed up by going to DC to meet with representatives from the democratic and republican HELP committee. The reps have been putting pressure on the FDA to meet with us and open an investigation into the claims made against Essure.
The women of the Essure Problems Facebook group will continue to stay on top of the FDA, sending them information and proof that this device is a dangerous, and risky form of sterilization, and much less effective than most other forms of birth control out there.
We have invited each member of the FDA that attended the meeting to join the group, and see what the reality of Essure looks like out in the real world, versus what they see on paper.
We have hope that the FDA will follow through now, after meeting with us and hearing some of what we had time to present. An hour seems like a drop in a bucket, we could have spent many, many more hours there. Maybe we will have time again in the future.
Thanks go out to Dr. Zuckerman and Dr. Tassone, for speaking on our behalf, and thank you to Coco Jervis for attending with us as well.
Thursday April 2, 2015
1. Kim Hudak- Essure Problems Administrator
2. Diana Zuckerman- National Center for Health Research
3. Angie Firmalino- Essure Problems Administrator
4. Angela Desa Lynch- Essure Problems Administrator
5. Shawn Tassone MD- OB/GYN Austin, TX
6. Coco Jervis- National Womens Health Network
7. Abiy Desta- FDA- Ombudsman firstname.lastname@example.org
8. Greg O’Connel- FDA/CDRH/OB- Branch Chief email@example.com
9. Anastasia Bilek- FDA/CDRH/OB- Acting DDRA firstname.lastname@example.org
10. Jim Saviola- CDRH- Director Division of Bioresearch email@example.com
11. Christopher Ronk- CDRH/OSB/DEPI- Branch Chief firstname.lastname@example.org
12. Beth Fritsch- FDA/OC/OHCA- Deputy Director email@example.com
13. MaryAnn Gornick- FDA/OCD firstname.lastname@example.org
14. Melissa Sage- FDA/OCD- Deputy Ombudsman email@example.com
15. Karen Riley- FDA/OC/OGA- Deputy For Strategy firstname.lastname@example.org
16. Elaine Blyskun- FDA/CDRH email@example.com
17. Julia Corrrado- FDA/CDRH/ODE/DRGUD firstname.lastname@example.org
18. Bill Maisel- FDA/CDRH email@example.com
19. Veronica J. Calvin- FDA/CDRH/OC/DBM- Branch Chief firstname.lastname@example.org
20. Joyce Whang- FDA/CDRH/ODG/DRGUD- Deputy Division Director email@example.com
21. Jason Roberts- FDA/CDRH/ODE/DRGUD- Biomedical Engineer/Head Review firstname.lastname@example.org
22. Mathew DiPrima- FDA/CDRH/OSEL/DAM- Materials Scientist email@example.com
23. Jeene Bailey- FDA/CDRH/DPLC/OC- CSO firstname.lastname@example.org
24. Eric Pahon- Office of Media Affairs,OC- Press Office email@example.com
25. Danica Marinac-Dabic- FDA/CDRH/OSB/DEPI- Director, Epidemiology firstname.lastname@example.org
26. Joy Stevens- Office of Legislation/OC- Leg. Analist email@example.com
27. Kim Gross- CDRH/OSB firstname.lastname@example.org
28. Marcy Busch- FDA/OCC email@example.com
29. Laura Bailis- FDA/OCC firstname.lastname@example.org
30. Marsha Henderson- FDA/OWH- Assistant Commish email@example.com
31. Helen Barr- FDA/CDRH firstname.lastname@example.org
32. Alison Lemon- FDA/OWH- Outreach email@example.com
33. Ben Fisher- FDA/ODE/DRGUD- Division Director firstname.lastname@example.org
34. Herb Lerner- FDA/ODE/DRGUD- Deputy Div Director email@example.com
35. Karen Jackler- FDA/CDRH/OCD- Public Affairs Specialist firstname.lastname@example.org
36. Ronald Swann- FDA/CDRH/OC/DMA- Supervisor CSO email@example.com