What is ICIJ investigation on medical devices?

By Indrajit Gupta

Published on 22, January, 2019

Health authorities across the globe failed to protect millions of patients resulting in 1.7 million injuries and nearly 83,000 deaths due to faulty medical devices over the last one decade reveals reports submitted to U.S regulator. In wake of this, International Consortium of Investigative Journalists (ICIJ) - an independent network of investigative journalists based in Washington D.C.investigated health issues arising from poorly developed medical devices and dug deep into the velocity of the risk factors they bring along.

ICIJ journalists around the world came together to explore public records of approvals, malfunctions, injuries, deaths, recalls, financial documents, court filings, government tenders and public donations related to medical implants to understand the routes taken by the devices manufacturers to deploy the products in the market. They also investigated the level of inspections the products go through and how regulators detect and act upon the findings.

More than 8 million health records including 5.4 ‘adverse-events’ reports to the FDA were collected and thoroughly studied. This led to an year-long investigation by ICIJ that later revealed the state of health administrations around the globe and how they are unable to prevent the usage of medical implants that are unreliable and poorly tested.

The findings by ICIJ discloses that governments allowed products on the market with little or no human testing that went on to cause great harm. The investigation highlights lobbying of companies, concealment of important data and evidence, bribing health professionals to sell defective medical implants, and receiving assistance from authorities in marketing the products.

The high-end devices that are implanted to improve an individual’s health carried along serious risks injuries and even led to death. Implantation of these underdeveloped devices caused heart attacks, punctured organs and other unwanted harm to patients globally.

ICIJ with its Implant Files investigation, questions whether the device industry is unnecessarily putting millions of patients at risk of serious harm in its quest for profit. Patients from around the world said that they have not been warned of the crucial risks and the terrible effects of their implants and have been duped into surgeries they have minimal or no knowledge about.

Findings from ICIJ reveal that some of the highest-profile controversies in recent years involve products marketed to women including female sterilisation implants and breast implants.

What’s worst, dozens of African and Asian countries including India and Pakistan have not yet enacted a Medical Device Regulation Bill which can monitor the quality of the devices exported or made in the country itself. “The Indian government has published a recall for only 23 devices, despite data from U.S. regulators showing thrice the number of devices being sold in India were recalled overseas between 2016 and 2017”, the ICIJ found.

Moreover, in the absence of a global foundation for recalls and safety notices, ICIJ decided to build a global resource for recalls and safety notices. The International Medical Devices Database (IMDD) for the first time gathers recalls, safety alerts and field safety notices - more than 70,000 from 11 countries - to create a searchable portal that anyone can access to help discover whether a device was flagged for official safety concern.