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The Implant Files: A Global Investigation of Medical Device-Related Injuries

November 27, 2018

The International Consortium of Investigative Journalists (ICIJ) has published a report on the findings of a year-long, global investigation into the regulation of implantable medical devices.

Investigators collected more than 8 million device-related records, including recall notices, safety warnings, legal documents, and corporate financial filings. These records include more than 5.4 million “adverse event” reports sent to the FDA over the last decade; the reports describe cases where a device is suspected to have caused or contributed to a serious injury or death, or has experienced a malfunction that would likely lead to harm if it were to recur.

Medical devices that broke, misfired, corroded, ruptured, or otherwise malfunctioned after implantation or use were linked to more than 1.7 million injuries and nearly 83,000 deaths over the last decade; nearly 500,000 reports mentioned a surgery to remove a device in connection with an adverse event.

The Implant Files investigation revealed that less than 20% of the countries in the world had public data online permitting citizens to find medical device safety alerts and recalls. The ICIJ has compiled an International Medical Devices Database (IMDD) of recalls, safety alerts, and field safety notices from 11 countries. The IMDD offers a searchable portal that anyone can access to discover whether or not a device was flagged for a safety concern. The initial November 25, 2018 data release includes data from 11 countries; ICIJ intends to add data from more countries, flagging each update on the IMDD as it appears.

The database allows users to explore events associated with the same product in different parts of the world. It covers not only implants, but a wide range of devices that have been recalled by manufacturers and reported to local authorities.

 

International Consortium of Investigative Journalists (ICIJ). ICIJ publishes new investigation: the Implant Files. November 25, 2018. Available at: click here. Accessed November 26, 2018.