The Implant Files investigation reveals damage caused by poor regulation and lax testing rules
• Why we’re examining the implants industry
Patients around the world are suffering pain and many have died as a result of faulty medical devices that have been allowed on to the market by a system dogged by poor regulation, lax rules on testing and a lack of transparency, an investigation has found.
Pacemakers, artificial hips, contraceptives and breast implants are among the devices that have caused injuries and resulted in patients having to undergo follow-up operations or in some cases losing their lives.
In some cases, the implants had not been tested in patients before being allowed on to the market.
In the UK alone, regulators received 62,000 “adverse incident” reports linked to medical devices between 2015 and 2018. A third of the incidents had serious repercussions for the patient, and 1,004 resulted in death.
In the US, the Food and Drug Administration (FDA) has collected 5.4m “adverse event” reports over the past decade, some from manufacturers reporting problems in other parts of the world.
These included 1.7m reports of injuries and almost 83,000 deaths. Nearly 500,000 mentioned an explant – surgery to remove a device.
The figures come from research by 252 journalists from 59 media organisations in 36 countries, which has uncovered a litany of problems in the global $400bn (£310bn) industry.
Examples of failure in the market include:
- Replacement hips and vaginal mesh products sold to hospitals without any clinical trials.
- Patients relying on faulty pacemakers when manufacturers were aware of problems.
- Complications with hernia mesh that ruled one of Britain’s top athletes out of competing for years.
- Regulators approving spinal disc replacements that later disintegrated and migrated in patients.
- Surgeons admitting they were unable to tell patients about the risks posed by implants because of a lack of central registers.
- Patients in Australia being given devices that the regulator has approved on the basis they have been approved in Europe.
The findings raise concerns about the level of scrutiny devices undergo before and after they go on the market, and whether regulators detect and act upon findings quickly enough.
Information about problems with devices is, in many countries, kept under wraps, making it difficult for patients to research procedures that have been recommended to them.
Prof Derek Alderson, the president of the Royal College of Surgeons, said there had been enough incidents involving flawed devices to “underline the need for drastic regulatory changes”, including the introduction of mandatory national registries for all implantable devices.
“In contrast to drugs, many surgical innovations are introduced without clinical trial data or centrally held evidence,” he said. “This is a risk to patient safety and public confidence.”
The Guardian and organisations including the BBC, Le Monde and Süddeutsche Zeitung, coordinated by the International Consortium of Investigative Journalists (ICIJ), have trawled through thousands of documents, many obtained through freedom of information (FoI) requests, to unearth some of the biggest problems.
Alongside interviews with patients and doctors, these have revealed flaws in the way the industry is regulated that are unlikely to be fixed by rules due to come into force in Europe.
Among the concerns raised by the Implant Files project are that manufacturers are in charge of testing their own products after faults have developed – and are allowed to shop around for approval to market their products, without declaring any refusals.
The Guardian has also heard about doctors who have close industry ties or seem eager to be early adopters of the latest devices to enhance their professional standing.
Plans for tougher EU rules have been watered down after industry lobbying, according to a huge trove of documents uncovered by the project.
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Dagmar Roth-Behrendt, the German MEP who led the EU’s move to overhaul medical device regulation, said lobbying by the industry and trade associations was “the blackest I’ve seen”.
She told the BBC: “I’ve seen a huge amount of [lobbying] in the 25 years I was in the European parliament [on] internal market legislation on food and on many other things – on cars, on tobacco, on whatever.”
In the UK, an FoI request sent to the Medicines and Healthcare Products Regulatory Agency (MHRA) revealed it had received an adverse incident report on average every half an hour over the past three years.
The reports related to a huge range of products including wheelchairs, beds and catheters as well as implants. Vaginal mesh, hip and knee replacements were among devices associated with thousands of the reports.
The MHRA passes all its reports on to manufacturers and in some cases sets up a serious investigation, led by its experts.
But data from FoI requests shows there has been a collapse in the proportion of investigations overseen by the MHRA at a time when complaints are soaring.
So far in 2018, one in 100 reports received have prompted it to start a special investigation, compared with one in three in 2008.
Instead, the majority of reports have been passed on to manufacturers and fed into the regulator’s “trending and surveillance” database.
Graeme Tunbridge, the group manager for devices regulatory affairs at the MHRA, said the fall in the number of investigations reflected a change in the way it worked.
“We have been moving towards a more sophisticated and trend-led approach.
“Most problems are systems-level issues, not unique to a single instance, for example where a whole batch is manufactured with a defect. Grouping incidents allows us to see the bigger picture and find the true causes of issues and solve them.”
The MHRA said reports received via its “yellow card” online reporting system did not necessarily mean there was a fault with a device, and that an adverse incident may be the result of a pre-existing medical condition, or the device may not have been used as intended.
Rules making it tougher for devices to get approval are due to be introduced in Europe in 2020.
Tunbridge said the MHRA had been instrumental in agreeing the new legislation, and that it would strengthen the regulatory framework. “Our highest priority is making sure the medical devices available in the UK work and are acceptably safe,” he said.
But critics remain sceptical.
Most devices are cleared through a pathway that allows new products to inherit the approval status of “substantially equivalent” ones that are already on the market, without the need for further trials.
In some cases, after lengthy chains of equivalence-based approvals, new devices scarcely resemble the original version, which may have been withdrawn from use.
Carl Heneghan, a professor of evidence-based medicine at the University of Oxford, said systemic failings in the way medical implants were regulated meant “patients are in one big experiment and they often don’t know it”.
He said the rules due to be introduced in Europe would not fix the structural problems. “You can’t see the evidence that a device is built on – that’s still the same,” he said. “It’s still commercial organisations that control the flow of data.”
Other FoI requests made to the MHRA underline how difficult it is to get information on what is going wrong with devices.
The Guardian requested details of incidents relating to the contraceptive Essure, but was turned down on the basis of commercial confidentiality. Such a response is not unusual, according to a recent paper by scientists.