Special Report- Robbed and Poisoned: Part 2 The Global Medical Device Debacle

I stumbled upon Bleeding Edge, a shocking Netflix documentary about the medical device industry. I knew I had to share this information with you, as it is even more disturbing than last week’s report about the generic drug industry.

Here’s a link to it’s trailer:

Next, I discovered,

The Implant Files

It is a global investigation that tracks the harm caused by medical devices that have been tested inadequately or not at all.

The site notes: 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.

The investigation was 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.

Key Investigation findings

  • 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
  • Devices pulled off the market in some countries over safety concerns remain for sale in others
  • The device industry, and the regulators that oversee it struggle to quickly identify hazardous implants after they are released, leaving patients exposed
  • 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
  • Some of the highest-profile controversies in recent years involve products marketed to women, including contraceptive coils, vaginal mesh, and breast implants

FDA Three failures lead to underreporting of harm

ICIJ’s Implant Files, has identified three critical failures that lead to underreporting of patient harm from implanted devices of all kinds. From public records requests and exclusive data analysis, ICIJ discovered:

  • Widespread violations of FDA reporting rules. FDA inspections have found more than 4,400 violations by device companies of its rules for handling complaints and reporting device problems in the last decade. Each violation can include hundreds or even thousands of mishandled complaints.
  • Repeated classification of patient deaths as less serious incidents. Manufacturers and others required to report adverse events have classified more than 2,200 episodes in which patients died not as deaths but as injuries, malfunctions or other less severe events in the last five years.
  • Burying patient injuries in reports that are not publicly disclosed. The FDA has allowed companies to obscure thousands of injury reports using a program called alternative summary reporting that allows them to keep the information from the public.

The vast majority of FDA incident reports come from manufacturers, which are required by law to report any deaths, injuries or dangerous malfunctions that they suspect may be linked to their products. These reports are made public in a database the FDA calls the Manufacturer and User Facility Device Experience, known as MAUDE.

Across all devices, more than 1.7 million suspected injuries and nearly 83,000 suspected deaths have been reported to the FDA in the past decade, according to an ICIJ analysis.

AdvaMed, the largest trade group for U.S. device manufacturers, disputed the idea that device makers fail to properly report patient harm.

“Companies are extremely cautious about their reporting, often reporting far beyond what is required by regulations,” said Janet Trunzo, AdvaMed’s Head of Technology & Regulatory Affairs. “Any suggestion that manufacturers under-report or somehow mischaracterize their adverse event reports is just wrong.”

The FDA told ICIJ that it has long acknowledged that its system for tracking the safety of devices after they are implanted has “limitations in promptly and consistently identifying safety risks,” and that it is implementing a more proactive “national surveillance system” that will rely on new and existing programs.

One initiative, called the National Evaluation System for Health Technology, will use large data sets from electronic medical records and other sources to evaluate device performance. Another, the agency’s relatively new Unique Device Identification System, already requires a unique identifier on the label and package of each device, which among other things is intended to more rapidly track down devices associated with adverse events.

Days before ICIJ began publishing the Implant Files, the FDA announced a goal of being “consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices,” citing the two new programs and others.

With all the shortcomings of its current system, the U.S. does collect and disclose data on adverse events. In most of the world, information on problems that emerge after a device is on the market is either hidden from public view or simply doesn’t exist. Europe’s Eudamed adverse events database remains accessible only to regulators and industry, not the public, and most European countries require Freedom of Information requests to access adverse event reports.

Other countries don’t track medical device problems at all. In Chile, health authorities told ICIJ journalists that adverse event reporting was voluntary for implanted devices and said that they had received only four “relevant” reports in a decade. In Mexico, authorities don’t share adverse event data with the public.

Here’s a few important links:

Medical Devices Harm Patients Worldwide As Governments Fail on Safety

Video Introduction

About the Investigation

Resources for Patients

International Database of Medical Devices