In 2014, medical regulators in Europe said they were minded to approve what they were told was a new medical device designed to treat incontinence. Close inspection may have revealed it was actually part of a bag used to hold oranges, bought from a supermarket by a journalist.
When presented with a completely fictional file of clinical evidence – which included the information that there was no data to support the safety of the product, and that one in three women would be scarred by it – three of the organisations allowed to approve devices for sale in Europe suggested there would be no problem taking it to the market.
That investigation, by the Dutch journalist Jet Schouten, suggested there was something very wrong in the world of medical devices. Other stories have underlined those concerns.
Last year, the Guardian wrote extensively about the harm done by vaginal mesh in the UK and Australia, unearthing figures showing thousands of women had undergone surgery to remove products that had caused complications.
The manufacturers of Essure, a permanent contraceptive, have been withdrawing it from markets around the world after reports of problems from thousands of women.
In Australia, women allegedly suffering from nickel poisoning and chronic pain have been urged to join a class action gainst the manufacturer.
In the UK and US, there is ongoing legal action taken by patients suffering pain and injuries caused by metal hip implants, while others suffering from faulty breast implants sold by the French manufacturer PIP are still fighting for compensation.
In Europe alone, the medical technology market is estimated to be worth €110bn (£98bn) a year. For this project we have focused on just part of it – the devices that end up inside people.
From tiny metal coils used as permanent contraceptives, to replacement metal hip joints, these fulfil a huge range of jobs and have improved many people’s lives. But when things go wrong the results can be catastrophic: patients living with chronic pain, needing surgery to put things right, sometimes living with a failed device inside their body for the rest of their days, or even dying.
Sometimes those failures are one-offs, but in other cases there have been repeated problems with devices, and it is these that are the focus of our investigation.
How many people need to report problems before regulators get involved? What happens when they do? How did these faulty implants make it on to the market in the first place? And how do prospective patients find out how safe something is before they go under the knife?
The Guardian has looked at a range of devices now known to have caused harm to patients to find out what went wrong and whether the problems could have been caught earlier.
We have followed their histories to find out how and where they were approved by regulators, when the first warning signs were spotted and what responses these prompted. Was there something wrong with the whole process? Were there weaknesses in the system? Are there improvements that can be made?
Healthcare systems are very different around the world, but manufacturers often operate globally. In Europe, makers have to get approval from only one notified body to give them access to the Conformité Européenne (CE) mark that allows them to sell a product. These notified bodies – organisations such as the British Standards Institution – hold the key to access to many millions of patients.
The Guardian has been able to examine the different hoops through which manufacturers have to jump to get their products into use in different parts of the world.
We have trawled through thousands of documents relating to product recalls around the world, and heard from dozens of patients who have suffered complications linked to their medical implants.
We have found tales of products allowed on to the market without testing because they resembled another already on sale, and of implants being recalled but patients not told they had one of the affected devices inside them.
We have heard from patients whose repeated complaints to doctors were brushed aside and whose symptoms were not linked to their implants until they had endured months of suffering.
We have also found an industry that is hard to scrutinise: registries of implants that are incomplete or non-existent, regulators who are unable to reveal which products they have received complaints about because of confidentiality rules, and legal settlements that are subject to non-disclosure agreements so patients can never report what happened to them.
Of course, there are many implants that change people’s lives for the better. Medical innovations have saved people’s lives and helped them live longer.
This investigation comes at an important time for the industry.
In the US, there is a push towards loosening regulation and making it easier for manufacturers to get their devices to market more quickly.
In Australia, an independent review of medical devices in 2016 recommended a registry be created for all high-risk implantable devices, such as breast implants and cardiac pacemakers. But more than two years later, the government is yet to adopt this recommendation.
By contrast, in Europe the rules are being tightened, with new medical devices regulations (MDR) due to come into effect in 2020.
But our investigations suggest the opportunity to solve many problems is likely to be lost as industry lobbying has led to proposals being watered down.
As a result, some of the problems we have found will not go away under the new rules. Reports of injuries and incidents linked to devices will in the main be kept from public scrutiny, manufacturers will still be able to get approval for implants they have not fully tested, the notified bodies that approve them will still lack medical experts on their panels, and patients will still struggle to find out the facts.
To help fill some of the information void, the International Consortium of Investigative Journalists is making available the International Medical Devices Database of information from partners around the world.