LAST UPDATE | 26 Feb 2020
PARENTS WHOSE CHILDREN with scoliosis have been implanted with a type of titanium spinal rod that has been recalled will be contacted within the next 24 hours.
Concerns had been raised by a patient advocacy group about a lack of communication between Children’s Health Ireland (CHI), the umbrella body for the country’s main paediatric hospitals, and parents about the recall.
CHI, which had previously confirmed that an audit was underway to establish if children in Ireland are affected by the safety notice, has now told TheJournal.ie that parents of children who may be affected will be contacted today or tomorrow.
“In the interim CHI are fully compliant with the recommended user actions,” a statement noted.
Earlier this month, manufacturer NuVasive issued an “urgent” Field Safety Notice (FSN) to inform healthcare providers caring for patients with MAGEC System Model X rods.
The device is made up of two titanium rods that are inserted during spinal surgery on children who have scoliosis (curvature of the spine). The rods have a small magnet that allows the rod to lengthen as the child grows.
Thirty-one such devices have been placed on the Irish market, but it’s not yet clear how many children could be affected or if any of the devices will need to be removed.
Claire Cahill, co-founder of the Scoliosis Advocacy Network, said there has been a lack of communication from CHI to parents about the issue, despite the safety notice being issued almost two weeks ago.
“Many parents are worrying unnecessarily. A huge amount of parents are worried and their child may not be affected at all,” she said.
Cahill said many parents may not be aware of the exact model of Magec rod that was implanted in their child and called on CHI to contact parents, letting them know if they are not affected or if a consultation may need to be arranged to check the status of their child’s implant.
“That’s the most important thing – that children are safe and safeguarded, and that parents are notified in a timely fashion. Open and transparent communication is needed,” Cahill told TheJournal.ie.
When asked about parents’ concerns, a spokesperson for CHI said: “CHI at Crumlin, where these rods have been part of some patient’s treatment plan, has commenced a review in order to establish if any of the small cohort of scoliosis patients who received MAGEC System Model X Rods since March 2018 were affected. This review is near completion.
The parents/guardians of children who have had a Model X rod implanted since March 2018 will receive communication from their Consultant Orthopaedic Surgeon within the next 24 hours. The surgeon will explain the issues to these families and deal with any of their understandable concerns.
A dedicated telephone line is in place for parents or guardians who have queries in relation to their child’s scoliosis related treatment or surgery at Crumlin. It will be open from 9am to midday on Monday to Friday on 01 409 6877.
The majority of scoliosis-related surgeries on children in Ireland are carried out at CHI at Crumlin in Dublin (formerly known as Our Lady’s Children’s Hospital, Crumlin) and it is the only paediatric hospital here that uses the MAGEC System Model X Rods.
The spinal rod devices are typically used in children with progressive scoliosis who are too young to undergo a full spinal fusion and who need a growing system to help straighten the spine but still allow growth.
31 devices on Irish market
The Health Products Regulatory Authority (HPRA) is also looking into the issue and told TheJournal.ie that 31 devices within the scope of the notice have been placed on the Irish market. However, the organisation noted that not all of these devices may have been implanted.
The HPRA has to date not received any incident reports about the rods from medical staff or patients in Ireland.
The HPRA is carrying out a market surveillance review of the MAGEC Spinal System in conjunction with the Medicines and Healthcare products Regulatory Agency in the UK.
When asked about this review, a HPRA spokesperson for the organisation cannot comment about it at present but “will be in a position to communicate the outcome of this review once it has been completed”.
“The manufacturer (NuVasive) has confirmed that they have issued the Field Safety notice in Ireland and the HPRA has subsequently followed up with relevant clinicians highlighting actions required and seeking any concerns or feedback they had in relation to the Notice.
“The HPRA has met previously with parents of children in Ireland who have received the MAGEC Spinal System and will continue to engage with these parents to discuss any concerns they may have related to the device,” a spokesperson said.
Parents of children who may have experienced an issue with this device have been advised to contact the HPRA or their surgeon directly. The Scoliosis Advocacy Network is aware of the issue and said a number of parents have raised concerns with the group about the recall.
Guidance for surgeons
In a statement issued on 13 February, NuVasive said that in a small number of cases the actuator end cap has separated from the rest of the device. The company said it is aware of the issue happening in approximately 0.5% of implanted devices.
The problem has only been observed in Model X rods, which were first manufactured on 27 July 2017, and the prior version of the rods is not affected. “The root cause of this issue is currently under investigation,” the company said.
In the notice, NuVasive recommends that “surgeons perform routine clinical follow-up and discuss potential clinical implications and risks with patients who received affected rods”.
The company added that removal of the device may not be necessary, but stated: “If an end cap separation is detected, removal of the device may be indicated. The decision to remove the device should be made by the physician in consultation with the patient and/or family.”
NuVasive said the notice has been “submitted to the appropriate regulatory authorities” and apologised “for any inconvenience that this action may create and appreciate your cooperation with our request”.
Recent research in the US has raised concerns about the failure rate of the devices, as did an investigation by BBC Panorama and others in 2018.
Separately, early versions of the MAGEC System Rods that were manufactured prior to 26 March 2015 were recalled in June 2019 after an internal metallic component fractured post-implantation in about 5% of the devices. These particular rods are no longer available for sale or implantation.
When previously asked in the Dáil about safety issues with the rods, Health Minister Simon Harris said the devices have been assessed at EU level and by the National Institute for Health and Care Excellence (NICE) in the UK to ensure they meet safety and performance requirements.
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