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. International Consortium of Investigative Journalists
he 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.

found at www.icij.org/investigations/implant-files, Nov 26, 2018
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