The Implant Files is a global investigation that tracks the harm caused by medical devices that have been tested inadequately or not at all.
Led by editors and reporters from the International Consortium of Investigative Journalists, it took a year to plan and another year to complete.
ICIJ partnered with more than 250 journalists in 36 countries to examine how devices are tested, approved, marketed and monitored.
Anchoring the probe is an analysis of more than 8 million device-related health records, including death and injury reports and recalls.
Millions of people’s lives have been saved, extended or made better by implanted medical devices but the Implant Files analysis encompassed more than 1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices over 10 years, and reported to the U.S. alone.
In the same period, the U.S. had more than 26,700 device recalls while India — with more than a billion people — had just 14 from 2013 to 2017.
Patients are often the last to know about malfunctioning devices.
Governments in dozens of countries in Africa, Asia and South America don’t regulate medical devices at all, instead placing their trust in European authorities or in the U.S. Food and Drug Administration.
To increase transparency, we are sharing a publicly searchable database of more than 70,000 recalls and safety warnings in 11 countries.
Inspired by Dutch journalist Jet Schouten, of broadcaster AVROTROS, the Implant Files investigation has expanded to embrace 58 media partners — newspapers, broadcast and digital outlets.
Despite relentless innovation, most high-risk implanted medical devices rely on prior trials involving actual patients and devices that manufacturers claim are “substantially equivalent.”
Manufacturers and governments are pushing for speedier approvals, which could further reduce trials.
The Implant Files examines critics’ claims that industry and regulators like the FDA are failing to protect patients.
Using a machine learning algorithm to screen millions of reports, ICIJ found 2,100 cases where people died, but their deaths were misclassified as malfunctions or injuries. Of these, 220 could be directly linked to medical device failure; the other reports did not include enough information to determine conclusively if the device played a role in the patients’ deaths.
The global team interviewed patients and doctors from New Delhi to Munich, and Mostar in Bosnia to Mexico City.
We spoke with doctor-inventors who have made millions of dollars from the medical device industry and are among its biggest promoters.
We met with critics lamenting financial incentives reaped by surgeons and hospitals for surgeries of questionable value.
We questioned regulators, canvassed manufacturers and lobbyists who have advanced the industry’s deregulations agenda.
We examined whistleblowers’ claims, explored academic papers and scrutinized the outcomes of device trials.
We probed implants that have killed, paralyzed, poisoned, shocked, burned, turned rancid inside patients’ chests and forced amputations.
Our investigation tells how implants can linger in the market even as injuries and deaths mount.
It reveals, too, how broken devices can be difficult, or impossible, to remove once implanted.
And it finds that lobbyists have twice wrecked bold EU plans to enhance device safety by establishing a centralized approval process that takes it out of private hands.
The global team made more than 1,500 Freedom of Information requests for access to government-held records.
We pored over thousands of FDA inspection records, identifying companies that failed to properly report patient harm.
We homed in on invitations to bid contracts for the supply of devices in many countries.
Our investigation into industry giant Medtronic’s history offers a window into some of the business practices of a $400 billion device industry that has developed sophisticated lifesaving products but also has pushed against or broken legal and ethical boundaries.
Like Big Pharma, the device industry is built upon a web of corporate and political influence.
The Implant Files is the story of the pain behind the gain of devices rushed to market, aggressively sold, then implanted in people.
The ICIJ Team
Director: Gerard Ryle
Deputy Director: Marina Walker Guevara
Project Manager: Fergus Shiel
Chief Reporter: Ben Hallman
Senior Editor: Dean Starkman
Data Editor: Emilia Díaz-Struck
Chief Technology Officer: Pierre Romera
Reporters: Sydney P. Freedberg, Scilla Alecci, Simon Bowers, Sasha Chavkin, Spencer Woodman, Cat Ferguson, Petra Blum, Dean Starkman, Delphine Reuter, Emilia Díaz-Struck, Fergus Shiel, Razzan Nakhlawi, Amy Wilson-Chapman and Will Fitzgibbon.
Editors: Dean Starkman, Ben Hallman, Tom Stites, Gerard Ryle, Martha M. Hamilton, Fergus Shiel, Emilia Diaz-Struck, Joe Hillhouse, Richard H.P. Sia and Charles Babcock.
Online Editor: Hamish Boland-Rudder
Data & Research Team: Emilia Díaz-Struck, Pierre Romera, Rigoberto Carvajal, Miguel Fiandor Gutiérrez, Cecile S. Gallego, Pauliina Siniauer, Margot Williams, Petra Blum, Delphine Reuter, Karrie Kehoe, Conrad Walters and Caroline Kubzansky.
Fact Checker: Richard H.P. Sia
Visual Journalist: Hilary Fung
Illustrator: Christina Chung
Community Engagement Editor: Amy Wilson-Chapman
Digital Producer: Razzan Nakhlawi
Video Reporting and Production: Scilla Alecci, Razzan Nakhlawi, Elaine Cromie, Amy Wilson-Chapman and Hamish Boland-Rudder.
Web Developer: Antonio Cucho Gamboa
Reporters
- Emilia Delfino (Argentina)
- Iván Ruíz (Argentina)
- Maia Jastreblansky (Argentina)
- Mariel Fitz Patrick (Argentina)
- Ricardo Brom (Argentina)
- Sandra Crucianelli (Argentina)
- Alexander Mann (Australia)
- Ali Russell (Australia)
- Alice Brennan (Australia)
- Alison Branley (Australia)
- Amy Wilson-Chapman (Australia)
- Conrad Walters (Australia)
- David Lewis (Australia)
- David Marin-Guzman (Australia)
- Edmund Tadros (Australia)
- Fiona Buffini (Australia)
- Gerard Ryle (Australia)
- Hamish Boland-Rudder (Australia)
- Inga Ting (Australia)
- Mario Christodoulou (Australia)
- Mark Doman (Australia)
- Misa Han (Australia)
- Neil Chenoweth (Australia)
- Rebecca Armitage (Australia)
- Sophie Scott (Australia)
- Stephen Hutcheon (Australia)
- Alain Lallemand (Belgium)
- Anne-Sophie Leurquin (Belgium)
- Delphine Reuter (Belgium)
- Kristof Clerix (Belgium)
- Lars Bove (Belgium)
- Saar Sinnaeve (Belgium)
- Xavier Counasse (Belgium)
- Allan de Abreu (Brazil)
- Anna Beatriz Anjos (Brazil)
- Bernardo Esteves (Brazil)
- Camila Zarur (Brazil)
- Gabriele Roza (Brazil)
- Jose Roberto Toledo (Brazil)
- Natalia Viana (Brazil)
- Vitor Hugo Brandalise (Brazil)
- Andrew Bailey (Canada)
- Andrew Culbert (Canada)
- Benoit Michaud (Canada)
- Cecile Rosner (Canada)
- Claudine Blais (Canada)
- Dany Croussette (Canada)
- David McKie (Canada)
- Gaétan Pouliot (Canada)
- Gillian Findlay (Canada)
- Jesse McLean (Canada)
- Lisa Ellenwood (Canada)
- Litsa Sourtzis (Canada)
- Lynn Mcauley (Canada)
- Madeleine Roy (Canada)
- Makda Ghebreslassie (Canada)
- Marcy Cutler (Canada)
- Mark Harrison (Canada)
- Martyne Bourdeau (Canada)
- Robert Cribb (Canada)
- Scott Anderson (Canada)
- Sylvene Gilchrist (Canada)
- Valerie Ouellet (Canada)
- Vik Adhopia (Canada)
- William Wolfe-Wylie (Canada)
- Andrea Insunza (Chile)
- Francisca Skoknic (Chile)
- Ignacia Velasco (Chile)
- Paula Molina (Chile)
- Rigoberto Carvajal (Costa Rica)
- Pavla Holcova (Czech Republic)
- Steffi Černá (Czech Republic)
- John Hansen (Denmark)
- Søren Kristensen (Denmark)
- Mónica Almeida (Ecuador)
- Minna Knus-Galan (Finland)
- Pauliina Siniauer (Finland)
- Tiina Lundell (Finland)
- Ville Juutilainen (Finland)
- Abdelhak El Idrissi (France)
- Cecile S. Gallego (France)
- Chloé Hecketsweiler (France)
- Edouard Perrin (France)
- Elodie Guéguen (France)
- Emeline Cazi (France)
- Emmanuel Gagnier (France)
- Jaques Monin (France)
- Julien Martin (France)
- Laetitia Cherel (France)
- Luc Hermann (France)
- Marie Maurice (France)
- Maxime Ferrer (France)
- Pierre Romera (France)
- Sophie Le Gall (France)
- Stéphane Horel (France)
- Anna Reuss (Germany)
- Antonius Kempmann (Germany)
- Arne Hell (Germany)
- Bastian Obermayer (Germany)
- Birgit Eger (Germany)
- Britta von der Heide (Germany)
- Carolin Fromm (Germany)
- Christian Baars (Germany)
- Christina Berndt (Germany)
- Christoph Giesen (Germany)
- Elena Kuch (Germany)
- Elisabeth Gamperl (Germany)
- Frederik Obermaier (Germany)
- Katrin Langhans (Germany)
- Markus Grill (Germany)
- Mauritius Much (Germany)
- Oda Lambrecht (Germany)
- Petra Blum (Germany)
- Vivien Timmler (Germany)
- Andras Petho (Hungary)
- Jay Mazoomdaar (India)
- Kaunain Sheriff (India)
- Ritu Sarin (India)
- Wahyu Dhyatmika (Indonesia)
- Colm Keena (Ireland)
- John McManus (Ireland)
- Karrie Kehoe (Ireland)
- Cataldo Ciccolella (Italy)
- Giulio Valesini (Italy)
- Gloria Riva (Italy)
- Leo Sisti (Italy)
- Paolo Biondani (Italy)
- Scilla Alecci (Italy)
- Simona Peluso (Italy)
- Chikako Yamaya (Japan)
- Keisuke Katori (Japan)
- Kenji Tamura (Japan)
- Kenta Iijima (Japan)
- Kohei Tomida (Japan)
- Masa Kado (Japan)
- Mikio Tanabe (Japan)
- Mizuho Kajiwara (Japan)
- Nobuo Kurihara (Japan)
- Rihito Karube (Japan)
- Takeshi Kurihara (Japan)
- Toshihiro Okuyama (Japan)
- Yasuomi Sawa (Japan)
- Yugo Hirano (Japan)
- Abdel Rahman Ayyas (Lebanon)
- Alia Ibrahim (Lebanon)
- Diana Moukalled (Lebanon)
- Hazem al Amin (Lebanon)
- Maya Ammar (Lebanon)
- Meriam Jbaily (Lebanon)
- Riad Kobaissi (Lebanon)
- Andrea Cardenas (Mexico)
- Daniel Lizárraga (Mexico)
- Dulce González (Mexico)
- Ignacio Rodriguez Reyna (Mexico)
- Jorge Carrasco (Mexico)
- Laura Sánchez Ley (Mexico)
- Mathieu Touliere (Mexico)
- Miriam Castillo (Mexico)
- Raúl Olmos (Mexico)
- Thelma Gómez (Mexico)
- Valeria Durán (Mexico)
- Xanic von Bertrab (Mexico)
- Ali Amar (Morocco)
- Salma Refass (Morocco)
- Alissa van Tricht (Netherlands)
- Jet Schouten (Netherlands)
- Joop Bouma (Netherlands)
- Linda Stoltenberg (Netherlands)
- Marco Visser (Netherlands)
- Martijn Roessingh (Netherlands)
- Tsui-Ying Leung (Netherlands)
- June Westerveld (Norway)
- Nina Selbo Torset (Norway)
- Tine Dommerud (Norway)
- Umar Cheema (Pakistan)
- Antonio Cucho Gamboa (Peru)
- Fabiola Torres (Peru)
- Jason Martinez (Peru)
- José Luis Huacles (Peru)
- Mayté Ciriaco (Peru)
- Rocío Romero (Peru)
- Anuška Delić (Slovenia)
- Maja Čakarić (Slovenia)
- Boyoung Lim (South Korea)
- Choi Yunwon (South Korea)
- Hong Wooram (South Korea)
- Jiyoon Kim (South Korea)
- Kim Kichul (South Korea)
- Kim Sungsoo (South Korea)
- Yeon Dahye (South Korea)
- Yongjin Kim (South Korea)
- Antonio Villarreal (Spain)
- Daniele Grasso (Spain)
- Jesús Escudero (Spain)
- Joaquín Castellón (Spain)
- Marcos García Rey (Spain)
- Miguel Fiandor (Spain)
- Nacho Calle (Spain)
- Verónica Ramírez (Spain)
- Helena Bengtsson (Sweden)
- Josefin Lennen Merckx (Sweden)
- Lotta Sima (Sweden)
- Ola Westerberg (Sweden)
- Barnaby Skinner (Switzerland)
- Catherine Boss (Switzerland)
- Marie Parvex (Switzerland)
- Oliver Zihlmann (Switzerland)
- Simone Rau (Switzerland)
- Malek El Khadourai (Tunisia)
- Pelin Unker (Turkey)
- Andrew Head (United Kingdom)
- Caelainn Barr (United Kingdom)
- Deborah Cohen (United Kingdom)
- Esther Oxford (United Kingdom)
- Hannah Devlin (United Kingdom)
- Hilary Osborne (United Kingdom)
- James Oliver (United Kingdom)
- Rebecca Coombes (United Kingdom)
- Simon Bowers (United Kingdom)
- Anna Schecter (United States)
- Adiel Kaplan (United States)
- Andrew Lehren (United States)
- Ben Hallman (United States)
- Brenda Breslauer (United States)
- Caroline Kubzansky (United States)
- Cat Ferguson (United States)
- Catie Beck (United States)
- Cynthia McFadden (United States)
- Courtney McGee (United States)
- Dean Starkman (United States)
- Emily Siegel (United States)
- Fergus Shiel (United States)
- Hilary Fung (United States)
- Holbrook Mohr (United States)
- Jeanne Lenzer (United States)
- Joe Hillhouse (United States)
- Justin Pritchard (United States)
- Kaitlin Sullivan (United States)
- Kalen Goodluck (United States)
- Kevin Monahan (United States)
- Lauren Dunn (United States)
- Maggie Fox (United States)
- Margot Williams (United States)
- Marina Walker (United States)
- Mark Schone (United States)
- Martha Hamilton (United States)
- Mary Beth Toole (United States)
- Matthew Perrone (United States)
- Maud Beelman (United States)
- Meghan Hoyer (United States)
- Michael Hudson (United States)
- Mitch Weiss (United States)
- Monika Mathur (United States)
- Peter Banda (United States)
- Razzan Nakhlawi (United States)
- Reese Dunklin (United States)
- Rich Greenberg (United States)
- Richard H.P. Sia (United States)
- Robert Dembo (United States)
- Sarah Fitzpatrick (United States)
- Sasha Chavkin (United States)
- Spencer Woodman (United States)
- Stephanie Gosk (United States)
- Susan Wagner (United States)
- Sydney Freedberg (United States)
- Tom Stites (United States)
- Will Fitzgibbon (United States)
- Emilia Díaz-Struck (Venezuela)
