International Investigation Exposes The Dangers Of Medical Implants
A world-first international investigation has turned the spotlight on medical implants, and it doesn't look pretty.
Almost 83,000 people around the world have died in the past decade due to potentially dangerous medical devices, an international investigation has found.
In the same time frame, 1.7 million people have been injured by the devices, including more than 8,500 Australians.
The International Consortium of Investigative Journalists (ICIJ) -- which includes the ABC, BBC and The Guardian -- trawled through thousands of documents to unearth facts about a wide range of medical devices on the market.
The project has been dubbed 'The Implant Files'. Out of it has come a portal called the International Medical Devices Database (IMDD), which carries critical information about recalls, safety alerts and field safety notices from a whole heap of countries. Anyone can access this database.
Why is it a big deal?
Each year, hundreds of medical implants and devices are identified as flawed, meaning safety alerts are issued or the product is recalled. Sometimes it takes months or even years for a recall to be issued globally, while the ICIJ has found times where vital warnings actually never reach doctors or patients at all.
For multiple reasons, some devices are recalled, withdrawn or banned in some countries but not in others.
The investigation has found that some world leading nations, such as the US and parts of Europe, actually export medical devices deemed too risky or unsafe for use in their own country.
Since 2008, manufacturers in the US and Europe have paid at least $2.2 billion to settle charges of corruption, fraud and other violations with regulators.
The companies must meet the rules of the countries where the products are sold.
The US Food and Drug Administration (FDA) has about 4,600 devices registered as "export only".
What about Australia?
According to the ABC, investigations have uncovered plenty of issues here in Australia, including problems with defibrillators, inadequate scrutiny of implants and failure to identify emerging safety issues. There were also claims patients are being kept in the dark about potentially dangerous devices and recalls.
The public broadcaster said this "raises questions about Australia’s regulator, the TGA, and how close it is to industry at a time when medical device approvals are skyrocketing"
Take Brisbane soldier, Wolfgang Neszpor for example.
The 42-year-old needed a shoulder implant after a decade serving his country and playing on the Australian Defence Force rugby team, the ABC reported.
The implant. which was new and made from pyrolytic carbon, was US made and hadn't been approved for use in the United States. The surgeon described the operation as "a new fantastic procedure" at the time in 2012.
Now, Neszpor can barely move his arm.
But years on from the operation, the device is now the top performing partial shoulder replacement. It's been used in 390 operations and in 19 cases, the device has had to be replaced.
Neszpor described himself as a "guinea pig" for the device.
If you need an implant or device, the advice is to check the product on the International Medical Devices Database