Breast implants
Patient advocates push US states to mandate breast implant warnings
Frustrated by FDA delays, some survivors are promoting laws to require informed consent before breast implant surgery in at least six states.
Implant Files
Health authorities across the globe have failed to protect millions of patients from poorly tested implants, the first-ever global examination of the medical device industry reveals.
In this investigation
Healthcare
Video: A Global Investigation Into Medical Device Harm
Patients around the world have become unwitting test subjects for new medical technology. Often following the trusted advice of their doctors, they have been injured, maimed and killed by poorly-tested implants.
By Scilla Alecci | November 25, 2018
IMPLANT FILES
Medical Devices Harm Patients Worldwide As Governments Fail On Safety
A global investigation reveals the rising human toll of lax controls and testing standards pushed by a booming industry.
By ICIJ | November 25, 2018
IMPLANT FILES
Medical device company chief arrested over ‘dummy’ implant scam
IMPLANT FILES
Medical device-related deaths being ‘miscategorized’ in key US database, study finds
IMPLANT FILES
US medical industry urged to reassess paid events amid doctor kickback concerns
IMPLANT FILES
Heart doctors more likely to implant devices from manufacturers that pay them, new study finds
PRESS FREEDOM
Implant Files reporters win partial release of medical device information in France
IMPACT
US regulator calls for ‘black box’ warning on breast implants
Healthcare
Bayer to pay $1.6b to settle thousands of US Essure injury claims
Healthcare
Essure injury complaints buried by Bayer, lawsuits claim
IMPLANT FILES
New study backs breast implant illness claims by patients
Healthcare
Lax testing of spinal cord stimulators threatens patient safety, consumer group warns
Breast implants
FDA warns Allergan over breast implant studies
COVID-19
Investigating the coronavirus: The ‘Wild West’ of unproven treatments
IMPACT
Spinal therapy tested on pigs and corpses banned in the UK
ARTIFICIAL INTELLIGENCE
We Used AI to Identify the Sex of 340,000 People Harmed by Medical Devices
Data journalism
Safety data from 20 countries added to Implant Files database
Accountability
Australian Patients Win in Closely Watched Mesh Class Action Against Johnson & Johnson
YOUR STORIES
Readers from 50 countries share medical implant stories
Impact
FDA challenged over metal implants ‘public health travesty’
Breast implants
FDA recommends tough warnings for breast implants
IMPACT
India strengthens medical device regulation
IMPACT
Allergan Recalls Textured Breast Implants Globally Due to Cancer Links
IMPACT
Australia set to join nations banning textured breast implants over cancer links
AWARDS
Implant Files honored with multiple awards around world
IMPACT
European regulators poised to reveal limited implant safety data
MY STORY
Implant Files reporter’s own medical device ‘nightmare’
IMPACT
FDA Releases Vast Trove of Hidden Medical Device Injury and Malfunction Reports
DEVICE SAFETY
European health ministers fight to postpone medical device safety laws
IMPACT
Canada joins textured breast implants ban over cancer links
TRANSPARENCY
The International Medical Devices Database now covers 26 countries
DATA JOURNALISM
Lessons from Inside the Implant Files
Breast implants
Patients ‘Discouraged’ As US Announces It Won’t Ban Cancer-Linked Breast Implants
Healthcare
US Halts Sale of Vaginal Mesh Blamed for Thousands of Injuries
IMPACT
Australia Announces Medical Device Action Plan to Address Patient Concerns
VIDEO
Video: The 30-Year Fight For Breast Implant Safety
IMPACT
Canada Halts Sales of Cancer-Linked Breast Implants, as Global Scrutiny Grows
IMPACT
France Bans Breast Implants Linked to Heightened Cancer Risk
Key findings
1
Medical devices improve and save lives, but governments have allowed products on the market with little or no human testing that went on to cause great harm
2
Devices pulled off the market in some countries over safety concerns remain for sale in others
3
The device industry, and the regulators that oversee it struggle to quickly identify hazardous implants after they are released, leaving patients exposed
4
Manufacturers, doctors, and others potentially linked more than 1.7 million injuries and nearly 83,000 deaths to medical devices in reports to U.S. regulators over the last decade
5
Some of the highest-profile controversies in recent years involve products marketed to women, including contraceptive coils, vaginal mesh, and breast implant
