Fianna Fáil health minister Stephen Donnelly misled the public when he wrongly claimed that a controversial surgery for children with serious spinal conditions had been suspended.
He made the claim last year in a written response to a parliamentary question about Magec rods, a type of spinal implant that has been the subject of a number of recalls and Health Products Regulatory Authority (HPRA) warnings.
Earlier this month, following outcry over the ongoing scandal at Temple Street Children’s hospital first reported by The Ditch, the Scoliosis Advocacy Network posted on X, formerly Twitter, suggesting that Magec rods “need investigation”
Donnelly last year wrongly claimed that the use of Magec rods had been suspended in Ireland.
This wasn’t the case.
Children’s Health Ireland (CHI) confirmed to The Ditch today that it has “continued to use Magec instrumentation” since 2020.
‘It remains unclear what information Donnelly relied on’
Magec manufacturer Nuvasive in February 2020 issued an “urgent field safety notice” over concerns about its Model X device and potential postoperative complications.
Two months later the Health Products Regulatory Authority issued a warning instructing surgeons not to use any Magec products.
“No Magec system rods of any model number shall be implanted pending completion of a market surveillance review of the system,” read the warning published by HPRA on 1 April, 2020.
The warning did however offer surgeons in Ireland the option of applying for approval to use the rods in “exceptional cases”.
Sinn Féin TD and party spokesperson on health David Cullinane raised the issue of defective rods in the Dáil in April 2022.
Health minister Stephen Donnelly issued a written response to the question claiming that the rods weren’t being used.
“Implantation of Magec rods remains on hold in Ireland since April 2020 following issuance of a manufacturer field safety notice by the manufacturer,” claimed Donnelly in his response dated 26 April, 2022.
Statements from both Children’s Health Ireland and HPRA have however proven Donnelly’s claim to have been false. CHI Crumlin continued using the implants.
“Since the field notice in 2020, CHI Crumlin have continued to use Magec instrumentation, on a case by case basis, if it is felt that this is the best option for a child, when all alternatives are considered. Prior approval is always obtained from the HPRA in these cases,” said a CHI spokesperson.
An HPRA spokesperson meanwhile told The Ditch it “has received six such requests (from CHI to implant Magec rods) during the voluntary pauses between May 2020 to date”.
The statement also confirmed that “the Magec spinal system currently remains on voluntary hold in Ireland”.
It remains unclear what information Donnelly relied on when he made the misleading claims in April last year.
Last week CHI published a report on spina bifida surgery at Crumlin children’s hospital that revealed in the case of one child, “Magec rods were removed due to disconnection and migration into pelvis.”
Donnelly has been contacted for comment.