‘Of course you can’t just buy a spring somewhere and say, put it in a child’
THE Dutch surgeon who invented the implant technique at the core of the Temple Street surgery scandal warned that the system could not be used with just any spring.
Details of the warning emerged as a letter from the Temple Street surgeon at the centre of the controversy was released via Sinn Féin leader Mary Lou McDonald in the Dáil this week.
The letter, apparently authored by Temple Street consultant Connor Green, appears to show that Eilísh Hardiman – the CEO of Children’s Health Ireland (CHI) – was told that ‘experimental’ techniques would be used at the hospital.
Dated February 2020, the letter from Mr Green to Ms Hardiman also states that families had been told that ‘off-label’ techniques would be used. ‘We have told families and told them these are offlabel and experimental techniques using devices not designed for this purpose,’ Mr Green’s letter states.
So far no families have come forward to say they knew about these experimental methods.
At the Oireachtas Health Committee on Thursday, Ms Hardiman said she had not received the February 2020 letter and had ‘absolutely no recollection’ of discussing the use of non-medical springs in surgeries with any clinician.
The pioneering Spring Distraction System (SDS), which Mr Green sought to emulate at Temple Street, was developed by a Dutch surgeon, Moyo Kruyt, who is professor of reconstructive skeletal engineering at Utrecht University in the Netherlands.
Still unlicensed today, the system remains classed as an investigational device pending appropriate authorisations.
However, speaking during a YouTube interview, posted online in September 2020, Mr Kruyt warned that not just any spring could be used for his technique.
‘As surgeons in the Netherlands – and I think almost everywhere else – we are allowed to do exceptional things for exceptional cases,’ he explained. ‘Of course you cannot just do it... There is legislation that allows you to start up such a treatment but it involves, of course, a lot of preparations and a lot of documentation.’
Outlining the extensive research that went into sourcing the correct materials to make the springs, Mr Kruyt said: ‘Of course, you cannot buy a spring somewhere and say, “okay, put it in a child”. There are, of course requirements, material requirements.’
This, however, is precisely what appears to have happened at Temple Street.
Explaining the lengths he went to to develop the springs his team needed, Professor Kruyt said the research process to establish the strength and properties of the metal he needed for implant springs took six months. After that the wire had to be sourced and certified as safe to be used inside human bodies as an implant material – a process that had to be done from scratch. Mr Kruyt said: ‘We first had to order like a hundred metres or some crazy length of wire, made I think, in China... That was shipped to America for some after-treatment and then to Sweden where this company is based that can do a certified process and then they came up with three of four of these little springs and the rest of the wire is still laying there. But we thought that this was the only way to do it and we got the springs and it was a great success.’
Professor Kruyt also spoke of how most orthopaedic implants would not have been invented if the rules currently in place had been around in previous decades.
He said: ‘I am confident that 90% of the implants that we have as orthopaedic surgeons now would never have evolved if these rules were applicable 30 years ago. Of course it makes a lot of sense to have these rules but it really frustrates innovation. I’m not saying we should stop these rules but you wish that there would be smarter rules for this type of research.’
In contrast to the way the Dutch team sourced its springs, Temple Street has confirmed it ordered off-the-shelf springs from a routine retailer which were not certified for use in humans. The procurement process for these springs is now part of the focus of inquiries by CHI and the HSE.
Also central to these probes will be the protocols and procedures in place at Temple Street for experimental surgical techniques.
In his February 2020 letter to Ms Hardiman, Mr Green demonstrated an apparent willingness to use unproven experimental methods.
Ironically, the motivation for resorting to these methods came from concerns about a licensed system that had been issued with a safety notice. That system – known as the Magec System Model X and developed by NuVasive – was subject to an urgent field safety notice in February 2020.
An amended version of the Magec system, adapted to correct a previous defect, went on the market in July 2020. However, Temple Street surgeons appear to have shunned the product in favour of their experimental methods.
‘We are allowed to do exceptional things’
‘Surgical implants are not regulated’
This was discussed in a November 2021 Oireachtas Health Committee meeting at which Mr Green was a witness. At the time, the committee was unaware that Mr Green was carrying out experimental procedures at Temple Street – something it appears he had informed his bosses of nine months earlier in the February 2020 letter to his CEO.
Speaking at the committee, Professor Damian McCormack, a colleague of Mr Green at Temple Street, was critical of regulatory standards. ‘The problem with surgical implants in this country is they are not regulated,’ he said.
Prof McCormack added that he had never allowed the Magec System Model X to be used in Temple Street – but warned of the risks of unregulated medical devices.
‘It comes down to regulation and we do not have regulation of surgical implants that is meaningful in this country. It is a huge problem.’
He said ‘Ireland is noted to be a soft-touch state where a surgeon would use an implant.’
Mr Green was also specifically asked at the committee about the Irish regulatory regime for medical devices but did not directly answer the question.