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FDA meeting room; image courtesy www.fda.gov.
FDA meeting room; image courtesy www.fda.gov.

In the ongoing fight to rid the market of an incredibly harmful medical device – Bayer’s Essure “permanent” sterilization implant, Essure advocates are meeting with the FDA today for a discussion on Essure’s safety and efficacy. What follows is the official press release from the advocates. We wish them all the best and great success today!

Graphic of Essure implantation; image courtesy of Petr Kovář MUDr. Havířov (Own work) via Wikimedia Commons CC BY-SA 4.0, image cropped for size.
Graphic of Essure implantation; image courtesy of Petr Kovář MUDr. Havířov (Own work) via Wikimedia Commons CC BY-SA 4.0, image cropped for size.

“On Wednesday, February 7, 2018, five Essure patient advocates, our legal representatives, and Device Events Founder and CEO, Madris Tomes, plan to meet with Commissioner Scott Gottlieb along with other officials from the Food and Drug Administration to request the marketing and distribution suspension of Essure until post-market studies are complete. The meeting will be held at FDA headquarters in Silver Spring, MD at 1:30pm.

We believe an immediate suspension of Essure is warranted. More women are being harmed as evident by the number of reported adverse events that have significantly increased over the last couple of years. The fact that the FDA issued a black box warning and a patient checklist, both of which are not being discussed or implemented with new patients, and that the newly ordered clinical trial data will not be available until 2023 is placing more American women in danger of being harmed. While Essure has been removed from every other market in the world, it remains on the market here in the United States. Every day that Essure is on the market it allows more women to be implanted with this potentially dangerous device without sufficient data to prove its safety. We will provide the FDA with newly collected evidence to prove why Essure needs to be suspended from the market.

Essure Attendees:

  1. Angie Firmalino, President, ASHES and Founder of Essure Problems
  2. Amanda Dykeman, Vice President, ASHES and Essure Problems Admin
  3. Angela Desa Lynch, Communications Director, ASHES and Essure Problems Admin
  4. Amanda Rusmisell, Secretary, ASHES Essure Problems Admin and Legislative Liaison
  5. Tess Schulman, Essure Problems Carolinas Admin
  6. Holly Ennis, Partner, Ennis and Ennis Law
  7. Justin Parafinczuk, Partner, KPWS
  8. Marcus Susen, Partner, KPWS
  9. Madris Tomes, Founder & CEO, Device Events

FDA Attendees:

  1. Scott Gottlieb, Commissioner
  2. Lauren Silvis, Chief of Staff
  3. Kathleen Quinn, Senior Advisor to the Chief of Staff
  4. Lauren Roth, Senior Advisor to the Chief of Staff
  5. John Martin, Principal Associate Commissioner for Legislation
  6. Maren McBride, Legislative Director, Office of Congressional Affairs
  7. Sharon Andrews, Branch Chief, Division of Reproductive, Gastro-Renal and Urological Devices, Center for Devices and Radiological Health (CDRH)
  8. Megan Gatski, General Health Scientist, Office of Surveillance And Biometrics, CDRH
  9. Cara Tenenbaum, Policy Advisor, Office of the Center Director, CDRH
  10. Candra Smith, Senior Policy Analyst, Office of the Commissioner
  11. Terri Cornelison, Assistant Director for the Health of Women, Center for Devices and Radiological Health (CDRH)”

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