The parents of a boy who had an unapproved spring implanted in a spinal surgery without their consent or knowledge have said the event amounts to a “complete breach of parental trust”.
In a statement, Liz McMahon and David Ryan said the very services that should have protected their son Luke, by providing safe healthcare, instead resulted in harm to an innocent child.
Luke was born with spinal muscular atrophy type 1 and scoliosis.
In July 2020, when he was six years old, a spring was inserted into his body.
That spring device then disintegrated inside Luke resulting in the necessity for further surgical intervention.
“Luke’s healthcare pathway was anything but the path that he should have experienced,” his parents said.
“Tragically, it is now abundantly clear as a child Luke was failed by the paediatric services at CHI.
“The very services that should have protected Luke, by providing safe healthcare instead provided what is now clear was an intentional act that resulted in harm to our son who was an innocent child.”
A review published today said the implantation of the unapproved devices “formed part of a well-intentioned but ill-considered effort to provide an alternative approach to surgical treatment, involving a single operation, for a number of children with life-limiting conditions” at Temple Street who had otherwise been facing multiple operations, each with its associated risks.
The 200-page review was published by HIQA into the use of unapproved implantable springs in spinal surgery at Temple Street Children’s University Hospital in Dublin.
The independent statutory review found that devices were implanted into three children and that “children were not protected from the risk of harm”.
The review said the use of these devices for scoliosis patients was wrong and there was no evidence of ethical approval at the hospital for their use by one surgeon, detailed as Surgeon A.
It found there was an attempt by Surgeon A to replicate an experimental surgical technique that was still under investigation at a hospital in another country.
‘Tip of the iceberg’
Luke’s parents said that HIQA, for understandable reasons, fails in certain situations to answer crucial questions due to conflicts in evidence.
They said they feared that the disclosures in the HIQA review are “only the tip of the iceberg of dereliction of governance standards at CHI”.
The family statement continued: “It can only be concluded that Luke was used for unauthorised experimentation where a non-medical grade spring was placed in Luke, in an attempt at CHI to replicate an unapproved surgical procedure, where the spring device was not approved for such use, nor was it ever designed for that purpose nor was it ever licensed for such medical use and it contained carbon steel that was not fit for purpose,” the parents said in a statement.
“We hope Luke’s unnecessary suffering will improve the lot of all children”
They said they were appalled by the failure of proper governance at CHI and the breach of trust.
They said it was clear that Luke was “used for experimentation purposes” with the unapproved springs without the family’s knowledge or consent.
“As parents, we could never have contemplated that an experimental non-medical grade spring would without our knowledge or consent be placed in our child in an Irish hospital.
“Such an event was a complete breach of parental trust by CHI.
“Those actions in a paediatric hospital setting are unforgivable. Such actions must have the most serious consequences, if faith in CHI is to be retrieved,” the statement continued.
The family called for the CHI Board to be relieved of their responsibility for the provision of services at CHI sites.
They added that the Government and Minister for Health must step up and take direct control for the future management of paediatric care at CHI hospital sites.
“We hope Luke’s unnecessary suffering will improve the lot of all children,” the family added.
