The Implant Files: The hidden human toll of lax controls on the booming medical device industry

Updated

Almost 83,000 people have died around the world, including 170 in Australia in the past decade, due to potentially dangerous medical devices, an international investigation into the global device industry has found.

In a world-first investigation, journalists from 36 countries have combined safety data, including more than 5 million "adverse event" reports, to create a global picture of the harm caused by medical devices.

The data has revealed 1.7 million people have been injured as a result over the past decade, including more than 8,500 in Australia.

The ABC worked in partnership with the International Consortium of Investigative Journalists (ICIJ) — the team behind the Pulitzer-Prize winning Panama Papers — for the global investigation.

It has revealed for the first time how lax regulations and vested interests have allowed dangerous and malfunctioning devices onto the market, putting patients' lives at risk.

Implants can improve lives, even save them. And device makers say the good their products do vastly outweighs the harm.

For The Implant Files investigation more than 250 journalists used data extrapolated from databases across the world to cross-reference public records of approvals, malfunctions, injuries, deaths, recalls, financial documents, court filings and even government tenders and political donations.

In total they collected more than 8 million device-related health records including 5.4 million "adverse event" reports sent to the US Food and Drug Administration (FDA) over the past decade.

And because there is no global resource for recalls and safety notices exists, the ICIJ decided to build one.

The International Medical Devices Database (IMDD) for the first time gathers recalls, safety alerts and field safety notices to create a searchable portal that anyone can access.

Australia part of 'free-for-all system'

In Australia, the safety of medical devices is regulated by the Therapeutic Goods Administration or TGA.

The investigation has revealed how the regulator's dependence on jurisdictions like Europe can mean problematic devices there, are exported here.

Background Briefing How safe are medical devices?

At their best, they save lives. At their worst, they cut them short. More than 57,000 medical devices are approved for use in Australia, but are patients aware of the risks? About

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At their best, they save lives. At their worst, they cut them short. More than 57,000 medical devices are approved for use in Australia, but are patients aware of the risks?

Risky medical devices undergo a process called "conformity assessment" before being approved in Australia. About 90 percent of these assessments, for the most serious devices, are carried out in Europe by for-profit private certifiers called "notified bodies".

It's a system once described as "pick and pay" by Jeffrey Shuren, director of the US Food and Drug Administration Center for Devices, in 2011 during congressional hearings.

"I don't think it's in the best interests of American patients, our healthcare system or the US companies," he said.

"Patients can get a device that's ineffective when they had alternative effective treatments. As a result, they put their health at risk, and the health care system winds up paying for it."

In Australia, a 2016 expert report written by former TGA director Derrick Beech — who today works as a medical device consultant — stated that medical device companies choose notified bodies partly based on their "speed of service".

Notified bodies are private companies which certify that medical devices and other products, are safe and conform with European standards.

"Manufacturers are anxious to get through the regulatory system as quickly and easily as possible to achieve revenue to recompense development costs," the report states.

Only the highest risk devices are automatically audited before being approved in Australia. Lower risk devices are audited on a voluntary basis.

In Australia, medical devices are divided

into four main categories: LOW RISK DEVICES Elastic bandages Tongue depressors Slings LOW-MEDIUM RISK DEVICES Contact lenses X-ray ﬁlm Intravenous tubing MEDIUM-HIGH RISK DEVICES Blood bags Condoms Surgical meshes HIGH RISK DEVICES Implantable deﬁbrillators Pacemakers Cochlear implants In Australia, medical devices are divided into four main categories: LOW RISK DEVICES Elastic bandages Tongue depressors Slings LOW-MEDIUM RISK DEVICES Contact lenses X-ray film Intravenous tubing MEDIUM-HIGH RISK DEVICES Blood bags Condoms Surgical meshes HIGH RISK DEVICES Implantable Pacemakers defibrillators Cochlear implants

The head of the TGA defended the approval system in Australia.

Deputy secretary Professor John Skerritt said it was wrong to say Australia "rubberstamped" approval given to devices in Europe.

"We call in additional evidence depending on whether we're not happy with what we see from Europe or for high-risk the devices we automatically call in the full gamut of evidence," he said.

"The Australian system isn't just the same as the European system it's very definitely Europe plus."

ICIJ reporters have found a March 2016 email between top health officials in Germany and Denmark that reveals regulators in the EU have no clinical data on an estimated 90 per cent of highest risk devices because they were assessed as "sufficiently similar" to existing products, a key criticism of European device approvals.

In recent years Europe has been seeking to strengthen its monitoring and regulation of medical devices. Several reforms have been introduced and will take effect in 2020.

The ICIJ investigation has also revealed how world-leading nations export risky medical devices deemed unsafe for use at home.

It's also found that in the United States and Europe, manufacturers have paid at least $US1.6 billion ($A2.2 billion) since 2008 to settle charges of corruption, fraud and other violations with regulators.

In 2017, the FDA approved more than three times as many devices as it did in 2010, while its warnings to device manufacturers about product safety fell by nearly 80 per cent.

When companies do report adverse events, they sometimes cloak their severity. The ICIJ found that manufacturers have classified an event as a "malfunction" or "injury" even if the patient died.

Using a machine learning algorithm to search millions of reports, the ICIJ found 2,100 cases where people died, but their deaths were classified as malfunctions or injuries.

Though the agency is issuing fewer warning letters it is conducting more factory inspections, the FDA said.

Do you know more about this story? Email backgroundbriefing@abc.net.au or Specialist.Team@abc.net.au



Australia is not immune

In Australia the investigation has uncovered problems with life-saving defibrillators, inadequate scrutiny of implants before they get on the market, a failure to identify emerging safety issues, and patients being kept in the dark about potentially dangerous devices and recalls.

It raises questions about Australia's regulator, the TGA, and how close it is to industry at a time when medical device approvals are skyrocketing.

Among those living with the fallout from these flaws are people like 27-year-old Chantelle Karo.

The Melbourne woman has a genetic condition called Hereditary Spastic Paraplegia (HSP), which makes her leg stiff and spasm, creating difficulties walking.

She needs a drug called Baclofen to relax her muscles and had a Medtronic Synchromed Pump implanted in May last year to inject the drug directly into her spinal fluid.

First released in 1988, the pump has radically changed the management of drug delivery for sufferers of chronic pain and spasticity.

Ms Karo hoped the pump would help her avoid life in a wheelchair or relying on a walking frame, like many people with HSP do.

"I wanted to improve my gait so I can walk just a bit better and look a bit normal," she said.

Many people with chronic pain use the same pumps to deliver drugs like morphine directly into their spinal fluid.

But around a year after the pump was implanted, problems began, starting with one morning while she was doing some work around the house.

"Bending over in the garden doing the weeding I noticed when it was moving back and forth — the pump itself would like pop out, it was almost like a foot."

The device had dislodged and come loose, and was flipping end over end, inside her.

Surgery failed to fix the pump and at a recent doctor's consultation, she was told the catheter — connecting the pump to her spinal cord — was potentially kinked and failing to deliver medication.

The condition, which Medtronic had warned about, in a worse-case-scenario can lead to serious injury or death.

Ms Karo's model of pump has been the subject of a number of recalls in the US. But it's unclear what is causing the issues with her pump and her specific serial number seems to be unaffected.

Ms Karo says she was never told about the issues with her model of pump.

"It's just a bit concerning not knowing since it's been implanted in me for a couple of years," Ms Karo said.

She wonders whether if she'd been properly told about the long-running issues with the device whether she'd have agreed to get one.

"I'm kind of regretting having it in with the problems I'm having."

The alarm sounding on devices (quite literally)

Sydney resident, 44-year-old Mathew Kennedy, had an earlier version of the pump implanted in 2003.

He said during a trip to Hong Kong in 2005, the pump began sounding an alarm — a persistent beep every minute coming from inside him. Mr Kennedy said Medtronic offered to remove the pump if he could fly to their offices in Tokyo.

However, Mr Kennedy said he could not afford the cost of the flight and had concerns that Medtronic would not return the pump once it was removed.

Mr Kennedy said he lived with the pump beeping inside him, for two years.

That's more than a million beeps.

"I tried everything, pillow over the head, staying up really really late and then sleeping for two or three hours, I had to play loud music or put headphones on or put my fingers in my ears," he said.

Mr Kennedy said he returned to Australia in 2007 after marrying. Upon arriving he said he travelled to Medtronic's Sydney headquarters to complain about the device.

"I said straight away, 'can you hear the beeping noise'. They said, 'Oh yeah we can hear it.' I said, 'that's because your f***ing machine's broken and I haven't been able to sleep the last two years because of this beeping noise'.

"They said, 'if you are going to speak like that, we're going to kick you out.' and I said 'I'm sorry I used a swear word but you have to understand I've had no sleep for two years pretty much because of this."

Mr Kennedy's model of pump was the subject of an urgent medical device correction put out by the company in August 2007 — the year Mathew said he had his pump removed. He said he was never told about the problems.

"They didn't even say there were any issues," he said.

Medtronic did not answer specific questions on Chantelle Karo or Mathew Kennedy's cases.

In a statement to the ICIJ, it said safety is its first priority but said it was important to understand that all medical products, no matter how well-designed and thoroughly tested, have potential risks.

It said it was wrong to "narrowly focus on isolated events ... while ignoring the millions of patients whose lives have been made better".

Focus on patients needed: experts

Academic Wendy Bonython from the University of Canberra is both a scientist and a lawyer and believes there are flaws in the way Australia regulates medical devices.

"There are patients who have suffered catastrophic consequences as a result of device failure," Associate Professor Bonython said.

"The TGA's focus is very much on manufacturers and the market. Somewhere along the line it needs to bring its focus back more on consumers and look at some of the consequences of device failure on consumers.

"People have a hard time getting people to take their concerns about their device seriously."

The TGA told ABC News it approved medical devices where the benefits outweighed the risks and conducted its own assessment before devices could be used in Australian patients.

"No product is without risk," TGA deputy secretary John Skerritt said. "We do fairly thorough reviews of the products.

"We're doing a lot more with our limited budget in encouraging patients to report."

He said the TGA had looked at the synchromed pump and warned hospitals about potential problems.

"Yes, there's been some problems in a small number of devices," he said. "We've communicated those issues to the hospitals who again have said to us 'look we'll phase those products out as new and improved devices come along' but they can't afford just to take them all to the tip."

Calls for reform

The body representing Australian device manufacturers said the vast majority of medical devices were safe but would support better reporting of problems.

"Our industry is committed to the highest standards of safety and quality," said Ian Burgess, the chief executive of the Medical Technology Association of Australia (MTAA). "[The industry] provides better quality of life for patients than otherwise would be the case."

In the past there have been calls to reform Australia's medical device approval system, most recently by the Senate inquiry into transvaginal mesh. The report's recommendations included:

Mandatory reporting of adverse events by medical practitioners

Establishment of a more comprehensive post-market monitoring scheme

A registry for all high-risk implantable devices

In October, the Government said it supported, in principle the vast majority of Senate recommendations, but said many require collaboration by federal and state governments along with medical professionals and the medical device industry.

Credits:

Reporting: Mario Christodoulou, Alison Branley, Sophie Scott and Alex Mann, ICIJ

Data: Inga Ting and Conrad Walters

Design: Alex Palmer

Digital Production: Mark Doman

Topics: doctors-and-medical-professionals, health, medical-procedures, medical-research, australia

First posted