MAGEC spinal rods suspended from supply in the UK due to safety concerns
On 1 April 2020, the UK medical devices regulator, the MHRA, issued a medical device alert to all clinicians stating that they should cease to implant MAGEC spinal rods.
Posted on 04 April 2020
The MAGEC spinal rods, manufactured by US company NuVasive Specialized Orthopaedics, have been used in hospitals across the UK to treat scoliosis in children, a congenital condition that can lead to severe spinal curvature and related developmental issues.
Paediatric scoliosis was traditionally treated through the implantation of metal rods along the spine to encourage correction of the spinal form and reduce curvature. However, for growing children, this can mean that they are exposed to repeated surgeries which can be both painful and traumatic as new spinal rods have to be implanted as they grow. The design intention of the MAGEC rod was to reduce the need for, and risks associated with, repeated spinal surgeries by creating a magnetic spinal rod that could be manipulated through the application of magnetic devices on the surface of the child’s skin; magnetically extending the rod as the child grows and thereby avoiding the need for, and risks of, repeated spinal surgeries.
However, MAGEC spinal rods have been the subject of repeated alerts by the MHRA from 2014 onwards, advising surgeons to be alert to potential issues with these devices including mechanical failures – such as ‘locking pin breakage’ and the generation of excessive metal debris when implanted. The latest alert is the most impactful to date – requiring that surgeons:
- Do not implant MAGEC rods in the UK until further notice
- Identify all patients implanted with a MAGEC System and ensure systems are in place to follow up these patients
It is anticipated that hospitals across the UK will now be required to contact patients implanted with this device and recall them to spinal units so that their devices can be monitored more closely, through repeated x-ray imaging.
The MHRA acknowledge that in the context of the current COVID-19 healthcare crisis the follow up assessments recommended by the MHRA alert may be delayed, and advises clinicians to risk assess each case and prioritise follow up accordingly. This will likely increase the anxiety of patients and their families affected by the MAGEC rod suspension.
The MHRA explains that it has been compelled to issue this alert because of mounting evidence within the scientific literature and adverse event reports received from clinicians that identify significant product failings which may affect the safety of these devices.
The MHRA has suspended implantation of these devices and urged closer hospital monitoring of patients wherever possible, whilst it undertakes its own investigations about whether the benefits of this device continue to outweigh the risks.
Clinicians and bio-engineers have long raised concerns about MAGEC spinal rods. These devices were one of several products focussed upon in Panorama’s Great Implant Scandal documentary which aired in 2018. They were also reported on by the International Consortium of Investigative Journalists (the ICIJ) in their groundbreaking study, ‘Implant Files’ reporting on medical device failures across the world.
Zahra Nanji, a product liability lawyer at Leigh Day commented:
“The suspension of MAGEC rods in the UK is to be welcomed. Over many years clinicians and researchers have raised questions about the safety of these devices which promised patients significant benefits, but which may well have exposed them to debilitating risks- and injuries affecting skeletal development as these patients grow into adulthood. The ICIJ in 2018 raised the alarm again about these devices, across all media and across the world. In that context it is concerning that the MHRA has taken until April 2020 to suspend this product pending its own independent interrogation of the available research. These devices were designed specifically for implantation in children and should have been subject to the highest levels of safety testing pre-marketing, rigorous post marketing surveillance and close observation by the MHRA. The latest MDA indicates that they may not have been.”