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

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.

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Source: The Ditch, 15 September 2023