Implant Files: Faulty Medical Devices Implanted Across the Globe

A global investigation reveals the impunity with which poorly designed medical devices were implanted in patients

In the first ever global examination of medical device industry, it’s found that millions of patients have been implanted with poorly-tested devices. Devices that have been let into the market by rules that are lax and lack transparency. The year long investigation was lead by the International Consortium of Investigative Journalists (ICIJ).

The damage caused by the lack of regulation has led to patients getting punctures in their organs, broken bones, poison being released in the body and shocks to the heart. Many have died.

Something similar came to light earlier this year in India, when Johnson and Johnson, a medical device manufacturer, was accused on implanting 1000s of patients with poorly designed hip implants that led to metal poisoning, loss of hearing, pain for some, death for others.

ICFJ journalists carried out 100s of interviews across the globe, each revealing how patients were hoodwinked by the medical device industry, not warned of risks or explained the complications.

In India, they spoke with, Vijay Vojhala, a 44-year-old Mumbai-based former hospital equipment salesman, who suffers from vision problems, difficulty walking and irregular heart rhythms. Earlier in a conversation with FIT, Vijay had described his ordeal:

I had an active lifestyle, but due to unforeseen circumstances, had to get a hip replacement surgery done in 2008. Being a medical representative, I had access to a lot of doctors and information about what’s new and best in the field. I decided to go for the metal-on-metal hip implant because the docs told me I could do everything from run to play tennis once I get the replacement. But what followed was a nightmare with metal poisoning, foggy mind, partial loss of hearing and unending pain.

ICIJ journalists and a team of more than 250 reporters and data specialists from 58 news organizations in 36 countries examined hundreds of cases like these from all over the globe.

Read FIT’s own investigation of the medical device industry and the unregulated mess we have in India right here.

Global Complaints

Sample this:

The Indian Express reports that since 2014, 903 medical device adverse events have been reported: 325 are linked to cardiac stents; 145 to orthopaedic implants; 83 to IUCDs (intrauterine contraceptive devices); 58 to intravenous cannulas; 21 to catheters, and 271 adverse events of various other medical devices.

In the UK , regulators received 62,000 “adverse incident” reports linked to medical devices between 2015 and 2018. 1,004 resulted in death, reports The Guardian

In the US, the Food and Drug Administration (FDA) has collected 5.4m “adverse event” reports in the past decade. 1.7m reports of injuries and almost 83,000 deaths were reported.

ICFJ says manufacturers have paid at least $1.6 billion since 2008 to settle charges of corruption, fraud etc in the US and other countries. Johnson & Johnson, has agreed to pay $4.3 billion to people in the US for implanting defective hip, mesh and surgical staplers.

In India, Johnson & Johnson has finally set up a reimbursement programme for patients affected by faulty devices. Some patients may get as much as ₹1.2 crore each in compensation, the minimum being ₹33 lakh, according to reports.