Unlicensed implants made with non-medical parts used in Temple Street spinal operations – surgery suspended

This reporting was supported by The Ditch's Micheál Martin Press Freedom Bursary.

Certain spina bifida-related surgeries remain suspended at Children's Health Ireland at Temple Street (CHI) for almost a year amid serious allegations that unlicensed devices made with non-medical parts have been implanted in child patients. In two cases where these devices were used, the implants had to be removed from patients after causing significant harm, while the efficacy of a third is yet to be determined.

One senior member at the hospital has raised concerns about the number of repeat operations required on young spina bifida patients and associated rates of reinfection, with disquiet in the hospital eventually leading to first an internal review of operations in October 2022 and later an external probe by US clinicians.

In June this year there were 287 children on waiting lists in Ireland for life-changing spinal surgery. Despite a commitment first given by then health minister Simon Harris in 2017 that no child would be on the waiting list for more than four months, there are still more than 120 children waiting more than a year for scoliosis surgery, according to the Ombudsman for Children.

CHI has declined to comment on allegations that one of its surgeons has used the unlicensed, failed implants, as well as its decision to cease operations on spina bifida patients.

Patient advocate Amanda Santry, who took part in the external review on behalf of Spina Bifida & Hydrocephalus Paediatric Advocacy, has said she has been denied access to the review findings and has also called for a “full investigation” into the allegations of the use of non-medical parts.

People Before Profit TD Paul Murphy, after repeated questions in the Dáil about the affair, has called for Stephen Donnelly to step in. “It highlights a fundamental problem of governance that this would simply continue unless someone spoke out about it. The minister for health should immediately commence an outside investigation into this practice,” he said.

‘I had never been in a hospital where alarm bells started ringing in my head’

Children's Health Ireland at Temple Street is one of the four hospitals administered by CHI in the greater Dublin area and, as one senior staff member who spoke to The Ditch on the condition of anonymity has said, the staff there do stellar work in an unforgiving environment for their patients, “In many ways, it’s a good hospital, they look after a lot of complex patients – and generally do it well – with only 90 beds to go around.”

This staff member however, who has extensive experience working in hospitals in Ireland and overseas, has never been more concerned with systemic and individual failures in a hospital than at Temple Street.

“Before Temple Street, I had never been in a hospital where alarm bells started ringing in my head,” they said.

“I’ve never seen so many complications of a specific nature come back and just not be discussed or, whenever they are discussed, it has blown over. It was so specific in that it was spinal surgery on spina bifida patients performed by one surgeon coming back and back and back for repeat operations because there was an infection; the wound wouldn’t close; the metal work had failed. To me it was really clear cut that there was a problem here,” they said.

I’ve spoken to this staff member for nearly a year and heard how their concerns about spinal surgery at Temple Street peaked in the summer of 2022, when they decided they had no choice but to do something about it.

“You were seeing these cases coming back. It was only the spine stuff. There would be one new operation – a spina bifida case – taking place on the emergency list and it just kept coming back and coming back,” they said. Blowing the whistle internally was not an option for them, believing that two other staff members were previously pushed out of the hospital after “falling foul” of colleagues.

A 2022 report by the Royal College of Surgeons in Ireland seen by The Ditch noted that the inspectors were “concerned to hear of behaviours across, and within, clinical teams that may be considered as bullying or harassment, although it was not considered that the hospital has a culture of bullying or harassment”.

Despite the report recommending that the hospital put measures in place “where individuals can safely speak up if they witness or experience inappropriate behaviour, so that these behaviours are challenged and not tolerated,” this staff member insists they have seen no evidence to date of that happening. Within weeks of submitting my first questions to CHI in October 2022, my personal details, including address, were circulating freely among other members of staff at the hospital.

‘The internal review was damning’

Less than a month after these questions were submitted, an internal review into spinal surgery at the hospital had been commissioned and some spina bifida surgeries were suspended in November last year. Talks also began on instituting an external review and, on 23 March this year, a contract was signed for a group of healthcare professionals from Boston Children’s Hospital to carry this out.

Although the most complex spinal procedure – called a kyphectomy – received most attention in this review, senior staff at the hospital have said that there have been serious failings with all spina bifida surgery at the hospital.

“There was one child who had dozens of operations over a seven-month period, they would be having a wound washout every few days. What I found abnormal about what was going on was the reaction to it. If it was abnormal and there had been some form of review or investigation or discussion or maybe a slowing down of procedures then I’d say, ‘Okay, maybe that’s understandable – they’re looking into it,” but there was none of that at all, that’s what was abnormal,” said the staff member.

The internal review was damning. It investigated 16 surgeries. Almost all resulted in complications for patients.

“When I’m looking at mention of dozens of operations on one patient, I’m thinking there is a serious problem; something has really gone wrong with that case that they need so many wound washouts. There was another patient who had nine operations and that’s too many. Three is too many,” said the staff member.

One of the surgeries included in this review involved the implantation in a child of an experimental and unlicensed device, a device constructed by a surgeon at the hospital and that later failed. Nowhere else in the world are these devices licensed – one team in the Netherlands are working towards clinical safety for the device but even this company’s website states clearly that its prototype shouldn’t be used on patients.

Two implants had to be removed. Uncertainties over a third

In April this year Paul Murphy began asking minister for health Stephen Donnelly written questions about Temple Street. Some of these questions concerned rates of reoperation and infection, while another touched on alleged “external or internal pressure being placed on clinical staff at Temple Street to restart spina bifida-related surgeries in advance of the conclusion of the external review”.

By June, Murphy was putting it to taoiseach Leo Varadkar, saying, “These reviews are taking place on foot of a much higher complication rate than would be usual and with allegations that unlicensed implants have been used in children,” and seeking the publication in full of both the external and internal reviews.

Central to these questions was the allegation that springs not meant for use in surgery were bought by at least one member of staff at Temple Street and subsequently used in an unlicensed implant, which was then implanted in at least three young patients during surgery. Other members of staff at Temple Street have said that this is indeed the case.

European Springs & Pressings Ltd, headquartered in Kent, have confirmed to The Ditch that it fulfilled an order to Temple Street in January 2020 for a consignment of 10 compression springs (at a cost of £4.58 per spring) that were not intended for use as implants in surgery. The company’s business development manager in Ireland says they had no idea of the end use for the springs and that, if they had known they were to be used in surgery, the company would have advised against it. The springs are made from low-grade steel, rather than the titanium alloy required to prevent corrosion. The company also doesn’t have the relevant certification to sell springs for use in medical implants. There is no suggestion European Springs & Pressings committed any wrongdoing in fulfilling the order for Temple Street.

No record has been found of other springs ordered by anyone in Temple Street in the relevant timeframe. Regardless there would be no accepted source for such a spring, as these implants have not been certified anywhere for use in patients.

In two of the cases where springs were used, the implants had to be removed after causing significant harm to the patients concerned.

“I remember the first time I became aware of springs being used in surgery was when a patient, who was supposed to be so sick that they only needed to have one operation, came back and forward for several operations, likely due to this strange spring that was implanted,” the senior employee at the hospital told The Ditch.

“When I asked the surgeon, they said it was from Woodie's hardware shop one day and then said it was from Amazon the next day and wouldn’t put down where it was from, so that was another alarm bell that rang.”

This staff member had never encountered such a device.

“I had never heard of a spring implant. I’ve never seen a spring used as an implant in orthopaedics before this. I’ve since read that there is a Dutch group who have tentatively developed an implant that this surgeon has obviously seen somewhere and thought to copy, but without due process and without using the proper metal. It’s bizarre,” they said.

‘Not available for sale or distribution’

The Dutch group is Cresco, which is developing an implant called a spring distraction system, under the appropriate conditions. The Cresco team has produced a number of peer-reviewed papers on its work discussing complications in patients, but have yet to attain medical registration for the implant and, in correspondence earlier this month, said that it doesn’t know of any “other novel implants for early onset scoliosis”.

“Currently only for use as investigational device and not available for sale or distribution,” reads a notice on the group’s website, while a researcher at the group told The Ditch they didn’t know when its implants will be ready.

“Work is underway to attain medical registration, as you know that is a task that requires some stamina, so how long that will still take I do not know,” he said.

The staff member at Temple Street sees a distinct difference between how Cresco is developing these implants and how the devices were just used on patients in Temple Street.

“Cresco has gone through a whole trial and design process to design the exact size of the spring and what way it would best fit, what metal is to be used, because you want something that’s non-corrosive. Then they’ve had it made by an appropriate company or institution with an adequate ISO, so that all the implants are made to a certain standard and then they’ve started using it, with a proper consent process where everyone is informed of what’s going on.

“In Temple Street, someone saw springs, bought them and just used them, had them sterilised and used them without any form of thought towards the type of metal. The regulations are so important: you have to follow them because otherwise it will fail,” they said.

'As of today our advocacy group are aware of the allegations'

There are now intensified calls for the findings of the hospital's review to be made public.

“As the mother of a child with spina bifida who has been continuously and repeatedly failed by CHI, I am astounded that we still have not seen sight of the external review report which I myself participated in,” said patient advocate Amanda Santry.

“As of today, our advocacy group are aware of the allegations that non-medical springs have been used in surgery in Temple Street and we want a full investigation to determine who may be ultimately responsible.”

The senior staff member meanwhile retains hope that a period of meaningful reform can begin.

“There has been wilful ignorance on the part of some at differing points, otherwise they would be speaking to someone or blowing the whistle,” they said.

“There was an absence of leadership from management as well. There hasn’t yet been a thought-out, ‘We need to restructure this’. The only movement that has happened really in terms of changes have been since the initial freedom of information requests went in (in October 2022). The new hospital has the potential to be a world-class facility but it would be self-defeating to bring serious bad practice and contempt for informed consent with us.

“We need to learn from best practice elsewhere in the world with complication rates of 80 per cent, these exhausting returns to theatre that we’ve witnessed just wouldn’t be accepted – so what are they doing differently?

“What can we do differently?”

Pádraig Ó Meiscill writes on current affairs. His work has featured in, among other publications, Red Pepper and the Irish News. More of his work can be read on Substack.