America has the most technologically advanced health care system in the world, yet preventable medical harm has become one of the leading causes of death, and the overwhelming majority of high-risk implanted devices never require a single clinical trial.

In THE BLEEDING EDGE, Academy Award nominated filmmakers Kirby Dick and Amy Ziering (THE INVISIBLE WAR, THE HUNTING GROUND) turn their sights on the $400 billion medical device industry, examining lax regulations, corporate cover-ups, and profit driven incentives that put patients at risk daily.  Weaving emotionally powerful stories of people whose lives have been irrevocably harmed, the film asks: what life-saving technologies may actually be killing us?

A Netflix Original Documentary
In Association with Shark Island Institute

Director
Kirby Dick

Producer
Amy Ziering
Amy Herdy

Editor
Derek Boonstra
Andy McAllister

Executive Producers
Jason Spingarn-Koff
Ben Cotner
Lisa Nishimura
Ian Darling
M S Johnson
Debra L. McLeod

Co-Executive Producers
Ken Grossinger
Micheline Klagsbrun

Music
Jeff Beal

Filmmakers

Kirby Dick

Director

Kirby Dick is a two-time Academy award nominated and two-time Emmy award winning documentary film director. His previous films include THE HUNTING GROUND, about sexual assault on college campuses; THE INVISIBLE WAR, a groundbreaking investigation into the epidemic of rape within the US military; TWIST OF FAITH, about a man confronting the trauma of child sexual abuse by a Catholic priest; THIS FILM IS NOT YET RATED, a breakthrough investigation of the MPAA’s secretive film ratings system; and DERRIDA, a complex portrait of the world-renowned French philosopher Jacques Derrida. He is the recipient of the Nestor Almendros Prize for Courage and Filmmaking, the Upton Sinclair Award, and the Ridenhour Documentary Film Prize. He is currently co-directing with Amy Ziering a film about sexual abuse in the entertainment business.

Amy Ziering

Producer

Amy Ziering is a two-time Emmy Award–winning and Academy Award-nominated documentary filmmaker. Her previous film, THE HUNTING GROUND— a piercing, monumental exposé of rape culture on college campuses—is the 2016 recipient of the Producer’s Guild of America’s Stanley Kramer Award and was nominated for the Academy Award for Best Original Song. She produced THE INVISIBLE WAR, an investigation into the epidemic of rape in the U.S. military, which won two 2014 Emmy Awards for Best Documentary and Outstanding Investigative Journalism and was nominated for an Oscar. She also produced OUTRAGE, DERRIDA and CAMERAPERSON. She is currently in the early stages of production on a Hollywood Assaults film, has three series in development with Dawn Olmstead at NBC/Universal, and a narrative feature in development with director Craig Gillespie (I TONYA) at Tobey McGuire’s Material Pictures.

Amy Herdy

Producer

Amy Herdy is a documentary film producer and author, specializing in investigative reporting for more than twenty years. A 2004 Denver Post investigative series she coauthored, “Betrayal in the Ranks,” about how the military mishandles sexual assault and domestic violence, spurred Congressional reforms and was a top-ten Pulitzer finalist. Herdy also worked as an investigative producer at KUSA-TV, where her interview with Ted Haggard created a firestorm when he unexpectedly confessed to buying meth from a gay male escort. Herdy received an Emmy for an investigative television series,  and additional awards from The Society of Professional Journalists, Radio-Television News Directors Association, Associated Press, The American Society of Newspaper Editors awards and Military Reporters & Editors.

Amy Ziering speaking inquiries: johna@peaceisloud.org

Press

Press inquiries: charlie@cineticmedia.com

"You'll wish [these interviews] were heard by every government official."

The New York Times

"So well reported and sourced that it transcends partisan politics."

Forbes

"Vital… Visceral."

Flavorwire

"Equally infuriating and enlightening... I yelled, 'Oh, my God!' multiple times while watching."

Village Voice

"Compelling… Powerful."

The Daily Beast

"A terrifying eye-opener... Exposes the massive health problems caused by the $400 billion medical device industry.

The Hollywood Reporter

"Triumph... A bone chiller."

The Mercury News

"Enlightening... A shocking expose of the medical device industry... [with] unnerving immediacy."

Indiewire

What People Are Saying

“This beautifully produced film lays out in intimate detail what happens when vested interests are able to dominate the research, production, and regulation of profitable new technologies that have the ability to harm. Interweaving the ringing pronouncements of medical device manufacturers with heartrending stories of those injured by their products, The Bleeding Edge gives lie to the fantasy that "unleashing innovation” can deliver us from the ills of the human condition.”

Helen HaskellFounder of Mothers Against Medical Error

“[The Bleeding Edge] has rattled the medical device industry and left countless viewers speechless.”

Medical Device and Diagnostic Industry

"As a health care culture expert I can assure you that no nurse or physician would knowingly participate in using a medical device that would harm their patients. "The Bleeding Edge" tells us something that we have never heard before: that our current system for approval is corrupt and causing serious harm to our patients. This film is a must see for every resident, physician and nurse. We cannot possibly protect our patients by choosing to remain in the dark."

Kathleen Batholomew, RN, MNAuthor, Nurse Leader

"[The Bleeding Edge] inspired anger among those inside and outside healthcare, prompting calls for change.”

Healthcare Analytics News

“An excellent, disturbing documentary about the need for better trials and evidence around medical devices, especially when it comes to women's health"

BMJ Sexual and Reproductive Health

“When I am a guest lecturer on the FDA approval process to audiences of students, doctors, patients, and consumers, they are always shocked to hear that FDA rarely requires clinical trials on medical devices to prove they are safe or effective. "The Bleeding Edge" provides very compelling examples of how those unbelievably low standards for devices can have devastating consequences for patients. It will be an important wake-up call for physicians, patients, and Congress. The message isn’t about specific products – the message is that none of us can feel confident about our medical care until the FDA requires evidence of safety and effectiveness for all medical devices.”

Diana Zuckerman, Ph.D. President, National Center for Health Research

“It should be a mandatory watch for everybody working in the medical device industry.”

Mike Drues, President, Vascular Sciences As quoted in Mike on Medtech Podcast

“Watching The Bleeding Edge made me wonder what the misuse of medical technology means for patients and for doctors... I believe we need a change of culture to avoid overuse of procedures or misuse of drugs and devices.”

Erich Anderer, MD NeurosurgeonAs quoted in Stat News

The E-Sisters

A note from Angie Firmalino, founder of Essure Problems and ASHES nonprofit:

Advocating Safety in Healthcare E-Sisters (ASHES) is a nonprofit organization I founded in 2015. The organization is run by a board of directors, who have been advocating and raising awareness regarding the dangers of a permanent birth control device called Essure. We help administer Essure Problems, a growing Facebook group with over 38,000 members, mostly consisting of women harmed by Essure. For seven years we have helped educate women concerning the potential risks associated with the device. We have also assisted thousands of women by providing emotional support, educational files and graphics, helping injured women finding competent doctors, and sharing detailed and updated information about proper Essure removal provided to us by physicians, in order to prevent women from suffering catastrophic botched surgeries. We have even been there on many occasions to talk women down from suicidal ideations, either by messenger or direct contact on the phone. My admin team and I have volunteered countless hours, days, months, and years, and have been 100% dedicated to this group and our fight to get Essure off the market.

After several years of running the Facebook group and being advocates for the women who experienced complications from the Essure procedure, we realized there was a dire need for proper and complete education and information regarding many medical devices. However, this urgent need involves raising funds to continue our fight. Up to this point, all of our advocacy work has been paid for out of our own pockets, which was becoming a huge burden for many of us. From that need, ASHES was born.

ASHES nonprofit exists to educate and inform women and men regarding the potential dangers of medical devices and the importance of researching as well as HOW to research, any medical device recommended by their physician. It also provides instruction on how to advocate on behalf of  those harmed by medical devices. ASHES also fights to raise awareness about the pitfalls of our FDA’s medical device approval processes and post market surveillance, and to help bring about much needed changes to these practices. ASHES was instrumental in getting three bills introduced in Congress regarding Essure and other medical devices covered by PMA, and Medical Device Safety.

ASHES relies solely on donations to the nonprofit to fund advocacy trips, rallies, events, and lobbying efforts. While we do not allocate funds to any individuals harmed by devices directly, we use funding for educational materials, travel costs, rally supplies,  mailings, operational costs, etc. The goal is to PREVENT others from suffering the same devastating harm that each of us has experienced personally from a medical device, and to fight for the rights of those who have been harmed.

Our current focus is on The Medical Device Safety Act of 2017, a bill currently in Congress, which if passed, will restore a patient’s right to litigation if harmed by a Class III medical device. ASHES members will also be working with other advocacy groups to get a bill introduced in Congress, which will revise the 510K process of medical device approval.

In July 2018, after seven long years of fighting, we achieved a thrilling victory. Days after our protest outside Bayer’s corporate headquarters, and one week before the release of The Bleeding Edge, Bayer announced they will withdraw Essure from the U.S. market. But the fight continues to help those already harmed by the device and to prevent future harm from other unsafe devices.

Donations to our nonprofit will help us continue our efforts in Congress to fight for changes to the FDA’s outdated and corrupt system of device approval. They also assist us in continuing to spread awareness through social media, websites, and allow us to continue to host rallies, protests, and patient engagement events.

If you would like to help ASHES by making a donation, please go to our website.

If you would like to support The Medical Device Safety Act, please do so here.

ASHES Board of Directors:
Angie Firmalino, President
Amanda Dykeman, Vice President
Angela Desa Lynch, Communications Director
Sarah Carlin, Treasurer
Amanda Rusmisell, Secretary
Lisa Saenz, Development Coordinator
Holly Ennis, Attorney
Kim Myers, Member At Large

Angie Firmalino

President of ASHES Nonprofit, Founder and Head Administrator of Essure Problems
Tannersville, NY

Amanda Dykeman

Vice President of ASHES Nonprofit, Head Research Coordinator And Administrator of Essure Problems
Orion, IL

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