On February 26, 2020, ASHES board members Holly Ennis and Angie Firmalino were invited to attend and speak at the 2020 Arizona Women's Health Conference, organized by Arizona Family Health Partnership.
Strengthening The Future of Women's Health was the purpose and goal of this conference.
There were two days of speaking events, breakout sessions, exhibitors, and wonderful meals provided by the conference, sponsored by Mercy Care, Care 1st, and University of Arizona College of Social and Behavioral Sciences.
Holly and Angie were panel speakers on Medical Devices and Patients Advocacy. Angie spoke about her experience with the medical device Essure, and her advocacy work to hep fight to remove the device from the market and her online support group Essure Problems. Holly spoke about the FDA rules and regulations of bringing medical devices to the market, and the challenges patients face with litigation if injured by a device. Both women were extremely excited to be a part of this amazing conference and hope to attend again in the future.
MhEEi was invited to speak to youth who are involved with an amazing non-profit organization Travel With Chaz. Mr. Charles Benson and his wife Jennifer created this organization for youths in their community to be able to attend events like baseball games, amusement parks and Pocono trips. They have a guns down, gloves up initiative to keep kids off the streets and in the boxing gym. Every Saturday, after boxing they have a workshop.
This Saturday, 11/16/19, we were invited to discuss mental health and suicide prevention. Lisa Saenz, Vice- President and her daughter Melody Saenz, advocate for safer mental health practices, provided much needed information to parents and children who attended. Suicide amongst our youth ages 4-17 has increased at an alarming rate. It is essential that parents and children are aware of the warning signs and when and where to seek help.
MhEEi discussed warning signs of suicide and how to regulate positive and negative emotions when they arise. Mental health was discussed and when to seek help. The youth were told they should talk about when they are happy and sad. When they are frustrated, angry or hurt, they are encouraged to talk about it. We also addressed bullying and some ideas about what children can do if they experience being bullied. We must work on this together, it takes a village to raise children. Please reach out to us if you have any questions, need assistance or would like to have a workshop, we can set this up. Resource handout was given along with a list of suggested workbooks.
On November 13-14, 2019, the FDA Immunology Device Panel of the Medical Devices Advisory Committee held a two day meeting to discuss the adverse events relating to metal-containing implants, including metal hip components, the Essure device and spinal fusion implants. The panel heard from over 50 presenters including physicians, patients harmed by metal-containing medical devices, as well as industry touting the safety of their products. The purpose of the meeting was to discuss the risks of immunological responses to metal placed in the body. Although it is claimed that adverse reactions affect only a minority of implant patients, when millions of patients are implanted with medical devices, this “minority” represents hundreds of thousands of harmed patients. The devastating damage can include severe pain, neurological damage, cognitive impairments and autoimmune disease. Additionally, there is little scientific research on autoimmune and allergic responses to metal-containing implants.
ASHES was well represented and some of the most powerful presentations came from members of the Essure Problems and Medical Device Problems groups. The most powerful presentation came from Dr. Steve Tower, the orthopedic surgeon featured in The Bleeding Edge who was seriously injured by metal-on-metal hip replacements. Moving testimony was also presented by Tess Schulman, Linda Radach, Frances Scott, Amy Barnette-Haycroft and Madris Tomes. The FDA will accept comments from the public concerning these issues until December 16, 2019 at https://www.regulations.gov/docket?D=FDA-2019-N-3767. Please comment and make your voices heard regarding this highly important issue.
On October 28, 2019, Angie Firmalino and Lisa Saenz attended the first Chronicon event in NYC. The event speakers can be found here
Attending Chronicon 2019 was so much more than we expected or could have anticipated. We have so much to process, a very exciting time. All of the panel speakers were amazing, knowledgeable, sincere and showed so much compassion. What Nitika Chopra and Healthline created and brought to this event was so much more than just a day of listening to amazing speakers, this is a movement, a movement that we wholeheartedly support. One that embodies a mind, body, and spirit approach, with a focus on dietary wellness.
ASHES board members are working on new connections made so that we may be a part of the panel next year. We felt so empowered and inspired to become a part of this movement!
On October 2, 2019, Lisa Saenz VP of ASHES and head of the MhEEi committee, attended a press conference on mental health.
It was a privilege to be invited to this press conference today in NYC near City Hall. NYC Public Advocate, Jumaane D. Williams and his supporters which included NAMI, Community Access and Coalition of Behavioral Health to name a few, discussed concerns surrounding mental health crisis response. In his published report, he discusses an urgency to change how we deliver crisis services, that currently, are often responded to by police officers.
These crisis call encounters often turn out poorly and leave many fighting further mental health trauma. We need our police officers, just need them for crime encounters not mental health crisis. Yes, there are trainings happening for our officers however; training is minimal and let’s be honest, they did not become police officers to handle mental
health crisis calls.
I was able to meet and greet with people who are committed and dedicated to forcing change in the current system that is failing. ASHES and MhEEi are committed as well to continue being the driving force and voice that is needed.
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.
We were able to present arguments that social media platforms such as Facebook, can provide relevant and reliable real world data more timely to the FDA, which may ultimately affect decisions such as whether to require updated labeling, additional post-market studies or even to recall a device. We advised that patient support groups, such as the Essure Problems Facebook Group, can be a virtual 'goldmine' of information quickly, as opposed to solely relying on years of MAUDE reports.
I am proud to say that the Essure Problems Group was also mentioned and used as examples by at least two other non-related speakers, heralding the achievements of the group in creating both awareness and advocacy.
To watch the presentations click here
Holly and Amanda are at the 4 hour mark.
November 1, 2018
It was such an honor and privilege to be invited to Medshadow Foundation’s first event. They are an organization advocating and educating the public on medication side effects. ASHES was invited to present on Medical Device Safety.
I was able to show through PowerPoint the amazing work the ASHES team is doing to bring awareness to medical device side effects. The audience consisted of doctors, medical professionals and students. Congresswoman Carolyn Maloney was also in attendance and gave an amazing speech. She took the time to talk with me about MDSA H.R.2164 and is interested in learning more about what ASHES is doing.
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:
Social Media & Web:
Twitter - https://twitter.com/CompAchieverPod
Facebook - https://www.facebook.com/CompAchieverPod
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 [email protected]
8. Greg O’Connel- FDA/CDRH/OB- Branch Chief [email protected]
9. Anastasia Bilek- FDA/CDRH/OB- Acting DDRA [email protected]
10. Jim Saviola- CDRH- Director Division of Bioresearch [email protected]
11. Christopher Ronk- CDRH/OSB/DEPI- Branch Chief [email protected]
12. Beth Fritsch- FDA/OC/OHCA- Deputy Director [email protected]
13. MaryAnn Gornick- FDA/OCD [email protected]
14. Melissa Sage- FDA/OCD- Deputy Ombudsman [email protected]
15. Karen Riley- FDA/OC/OGA- Deputy For Strategy [email protected]
16. Elaine Blyskun- FDA/CDRH [email protected]
17. Julia Corrrado- FDA/CDRH/ODE/DRGUD [email protected]
18. Bill Maisel- FDA/CDRH [email protected]
19. Veronica J. Calvin- FDA/CDRH/OC/DBM- Branch Chief [email protected]
20. Joyce Whang- FDA/CDRH/ODG/DRGUD- Deputy Division Director [email protected]
21. Jason Roberts- FDA/CDRH/ODE/DRGUD- Biomedical Engineer/Head Review [email protected]
22. Mathew DiPrima- FDA/CDRH/OSEL/DAM- Materials Scientist [email protected]
23. Jeene Bailey- FDA/CDRH/DPLC/OC- CSO [email protected]
24. Eric Pahon- Office of Media Affairs,OC- Press Office [email protected]
25. Danica Marinac-Dabic- FDA/CDRH/OSB/DEPI- Director, Epidemiology [email protected]
26. Joy Stevens- Office of Legislation/OC- Leg. Analist [email protected]
27. Kim Gross- CDRH/OSB [email protected]
28. Marcy Busch- FDA/OCC [email protected]
29. Laura Bailis- FDA/OCC [email protected]
30. Marsha Henderson- FDA/OWH- Assistant Commish [email protected]
31. Helen Barr- FDA/CDRH [email protected]
32. Alison Lemon- FDA/OWH- Outreach [email protected]
33. Ben Fisher- FDA/ODE/DRGUD- Division Director [email protected]
34. Herb Lerner- FDA/ODE/DRGUD- Deputy Div Director [email protected]
35. Karen Jackler- FDA/CDRH/OCD- Public Affairs Specialist [email protected]
36. Ronald Swann- FDA/CDRH/OC/DMA- Supervisor CSO [email protected]