83,000 people around the world and 170 people in Australia have died in the past decade due to adverse effects from medical devices.
A further 1.7 million people around the world, including 8,500 Australians, have been injured. These are the findings of the Implant Files, a year-long investigation by the International Consortium of Investigative Journalists (ICIJ), the team behind the Pulitzer Prize-winning investigation into the Panama Papers.
Over 250 journalists from 36 countries reviewed health records, analysed incident reports (including “adverse effect” reports) and interviewed patients. They discovered a profit-motivated industry with insufficient safety regulations.
Medical devices that pose a high risk undergo a “conformity assessment” before their usage is approved in Australia. However, about 90 per cent of these are carried out in Europe by for-profit certifiers.
Lower risk devices are audited on a voluntary basis.
Who is at risk?
In Australia, medical devices are divided into four categories: low risk (e.g. elastic bandages), low-medium risk (e.g. contact lenses), medium-risk (e.g. blood bags) and high risk. The latter category includes devices such as pacemakers, cochlear implants and implantable defibrillators. Users of these devices are the most at risk.
An in-depth article by ABC News uses the example of two Australians: 27-year-old Chantelle Karo, who has a hereditary condition called Hereditary Spastic Paraplegia, and 44-year-old Mathew Kennedy.
Both had the Medtronic Synchromed Pump implanted with painful and alarming side effects. Ms. Karo experienced the pump dislodging and coming loose inside her, failing to deliver the medication. Mr. Kennedy experienced the pump consistently beeping inside him rendering him unable to sleep for two years, forcing him to visit Medtronic’s head office to complain about the device.
Noticing the lack of a global resource for safety notices and recalls, the ICIJ decided to build one. The searchable database is called the International Medical Devices Database: https://medicaldevices.icij.org.
Their aim is to help patients find out whether a new implant or an implant they may be considering has any safety issues.
In its first release, the Database allows users to explore more than 70,000 safety alerts and recalls in 11 countries. ICIJ intend to add data from more countries as it becomes available.
If you or a loved one has been hurt by any of the deadly devices, Shine Lawyers can help you make a compensation claim.
Shine Lawyers are experts in the field of medical law. If you or a loved one has been impacted by deadly medical devices or any other form of medical negligence, you can talk to us about making a claim. Our lawyers work on a “no win, no fee” basis.
Written by Shine Lawyers on November 29, 2018. Last modified: February 1, 2019.