News National Medical device trials used Australian ‘guinea pigs’

Medical device trials used Australian ‘guinea pigs’

Wolfgang Neszpor says he feels like a medical device guinea pig. Photo: ABC
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As a soldier, Wolfgang Neszpor spent a decade serving his country. But he never expected his most serious injury to come when he was safely back home in Brisbane.

These days the veteran can barely move his left arm after becoming a “guinea pig” for a prosthesis that was made in the United States but never approved there for use.

Mr Neszpor is one of the many victims of a poorly regulated global market for medical implants and devices that is the subject of The Implant Files investigation, a collaboration involving ABC News and the International Consortium of Investigative Journalists.

The product Mr Neszpor used was a partial shoulder implant that the 42-year-old needed following years serving in the infantry and playing in the Australian Defence Force rugby union team.

“Back then, being a bigger size person, you’re sort of like a pack horse and they just load you up with everything,” he said.

After popping his shoulder several times on the rugby field, he suffered his most catastrophic injury during a game in Darwin.

Wolfgang Neszpor had hoped the PyroTITAN would fix his shoulder. Photo: ABC 

“I went to tackle somebody and the shoulder felt a bit warm,” he said, recalling the incident. “[They] told me that there was absolutely no rotator cuff left. I sheared the whole thing clean off the joint.”

In November 2012, after multiple operations, the father of six found his way into the surgery of one of the country’s most respected shoulder surgeons, Phillip Duke.

Dr Duke recommended a partial shoulder replacement using a device called a PyroTITAN.

It was a new type of pyrolytic carbon implant, a durable material made from sheets of graphite.

Mr Neszpor said his surgeon described the operation as a “new fantastic procedure” and that there was a requirement to perform 300 of them to “get them passed off as mainstream”.

“When your shoulder is bad, you take anything,” Mr Neszpor said, even though at the time he knew he was in a clinical trial and there was a proven steel alternative available.

‘A stupid amount of pain’

The pyrolytic carbon device is favoured for its smoothness, particularly for use in younger patients because it can preserve more of their joint, for longer.

Mr Neszpor said his doctor persuaded him to take the carbon option. But what he wasn’t told was that five months earlier PyroTITAN’s makers, Integra LifeSciences, had issued a voluntary recall after it observed one of its devices had cracked.

“I wasn’t really warned of the potential of it breaking,” Mr Neszpor said.

“He mentioned one of them failing; didn’t mention anything else.”

About two months later, sitting in the bedroom he went to move his arm and heard a loud, audible squeak.

It was loud. You could really hear it outside my body. I’d go to move the arm and it kept jamming.”

Mr Neszpor said while he knew he was in a clinical trial he had no idea the device could crack under everyday conditions.

“I can take a fair bit of pain. But it was a stupid amount of pain.”

Dr Duke said he could not comment on individual patients but said he prioritised patient safety above all else.

“I strive to ensure that the research is conducted in full compliance with all applicable regulations and medical ethics guidelines, and with the full disclosure of any known risks to trial participants.

“All the participants are fully aware of the experimental nature of the device.”

Within a year of Mr Neszpor’s surgery, the Therapeutic Goods Administration had followed Integra’s lead, also issuing a broader hazard alert because of a high breakage rate among PyroTITAN devices.

It reported that some devices could break when faced with excessive loads on the shoulder.

Unusually high failure rate

It wasn’t until 2014 that the veteran turned to Des Soares, a prominent orthopaedic surgeon who has sat on expert government panels.

Dr Soares, a part-time political adviser who’s been critical of the device pricing system in the past, had to perform a total shoulder replacement.

He questions how the PyroTITAN implant ever got approved for use by the TGA.

In his view, the device was “a bit thin” and was not suited for the particular joint.

Serious complications: The PyroTITAN failed once implanted. Photo: ABC 

“In a shoulder, I think it’s probably not an appropriate implant.”

The ABC News investigation has learned that instead of getting normal approvals to run a clinical trial, the makers of the PyroTITAN were granted general registration for the device in Australia, known as an ARTG number.

This allowed the device to be sold to doctors in public hospitals outside the clinical trial.

Data from the National Joint Replacement Registry suggests 13 surgeons have implanted the PyroTITAN, that’s about nine more than were involved in the Australian trials.

Some orthopaedic surgeons have suggested to ABC News it was their colleagues who were less familiar with the procedure that led to the unusually high failure rate of the device in its early days, prior to the hazard alert.

Dr Soares said the situation exposed serious flaws in the system.

“That’s absolutely inappropriate. To be doing experimental surgery without any evidence or data is where we lead to disasters,” he said. “And unfortunately patients are the people who suffer in those disasters.”

Even Dr Soares was surprised to discover the PyroTITAN did not have US Food and Drug Administration approval and said surgeons were relying on the regulator, the TGA, to get it right.

“As a busy clinician, I don’t actually physically go back and check that every implant I use has approval,” he said. “I assume that a company which is supplying it to me in a hospital is not going to lie to me.”

The surgeon said Australia’s system of clinical assessment before a product made it to market was “very broken”.

He said the TGA needed to accept responsibility for not having clinical assessment as part of its criteria.

“The TGA basically does a paper assessment and looks at materials, but does not have clinicians giving them advice and that is a big failure in our system.”

In a statement, the regulator said the PyroTITAN was initially approved as a Class IIb device, which meant its approval was predicated on having obtained approval in Europe. It added that Australian approval was not contingent on FDA approval.

It said now, following a decision by the government, all orthopaedic implants introduced after 2012 will be given a level III classification, because of their higher level of risk. This would result in an immediate in-house review by the TGA before approval.

“The TGA draws on the expertise of a range of in-house assessors and external specialist professionals, as well as the work of overseas regulators,” it said.

It said the PyroTITAN was allowed back on the market in 2014 after the regulator had overseen “corrective actions” and there was now “very strict quality control measures”.

‘You just feel like a guinea pig’

PyroTITAN was made by a company called Ascension Orthopedics, which was bought by Integra Life Sciences in 2011.

Ascension Orthopedics marketing material suggests the studies it used to support the PyroTITAN’s use were around the use of pyrolytic carbon in wrists and knuckles.

It is believed that Ascension obtained its initial European approval by arguing that its product was “substantially equivalent” to its other steel devices and that prosthetics made from different materials would be compatible.

But experts say that the new product should have either undergone animal, cadaver or biomechanical testing in a lab.

The Australian regulator, the doctors involved and Integra have refused to say whether this was done or release the materials they submitted to gain approval in Europe or Australia.

In a statement, the TGA said approval data submitted to the regulator was given on a commercial-in-confidence basis but could be released under certain circumstances.

Mr Neszpor’s surgeon, Dr Philip Duke, who ran the trials in Australia, told ABC News he was unaware the device had been supplied by its manufacturer outside the clinical trial.

“We undertook and are undertaking a research project fully approved by the appropriate ethics committees by the hospitals involved.”

Data from the National Orthopaedic Joint Registry suggests since the hazard alert the device is now the top-performing partial shoulder replacement, it is the most used and has the lowest replacement rates.

In the eight years since it was introduced in Australia, the device has been used in 390 operations. In 19 cases, it has had to be replaced.

“It does show that the results of the use are exemplary and better than most, if not all, other alternatives for shoulder replacement,” Dr Duke said.

A statement from the product’s maker, Integra LifeSciences, said the device went through extensive pre-clinical performance evaluation, including “biomechanical, strength, wear and impact testing”, which demonstrated it was safe and effective.

“PyroTITAN … has enabled many patients to regain the mobility of their shoulders.”

‘Export only’ devices

About 4600 devices are registered with the FDA as “export only”
Devices may be sold overseas despite failing to meet standards for sale in the US.

Companies do not need to conduct post-market surveillance, analyse adverse event data, review customer complaints or other action to monitor safety mandatory for devices sold in the US

Companies must meet the rules of the countries where the products are sold.

More than a dozen export-only devices have been linked to injuries and one death, an investigation by NBC News has found

The company said it had complied with all regulations, that it was committed to patient safety and continued to monitor the performance of the device.

In a statement, the FDA said it did not have the authority to take action on export-only devices marketed in other countries.

All that is little solace for Mr Neszpor, who knows his full shoulder replacement, which he needed after the PyroTITAN cracked, may not last the decade.

“I’ll either have a flaccid arm if this goes down or I have a fused shoulder,” he said.

“That’s it, 42 years old. You just feel like a guinea pig.”

Explore the International Medical Devices Database, a searchable portal that gathers global recall notices, safety alerts and field safety notices.