Once again, the lack of legislative safeguards in place for medical devices (as opposed to medicines) here in Ireland is brought into focus by the publication of an “urgent” Field Safety Notice Field Safety Notice Field Safety Notice by manufacturers NuVasive dated the 13th February 2020.
The purpose of the Notice was to inform healthcare providers caring for patients who have had MAGEC System Model X rods inserted during spinal fusion surgery for scoliosis.
Scoliosis is a structural lateral curvature of the spine and affects around four children per thousand.
The MAGEC system comprises a magnetically distractible spinal rod implant and an external remote controller which lengthen the rod; this system avoids repeated surgical lengthening.
The Notice states that post-implantation separation of an actuator end cap component has been observed in MAGEC System Model X rods, approximately 0.5 % of them. It goes on to advise that separation of the end cap may expose internal components of the actuator, which could lead to “hastened degeneration of the internal components and egress of Titanium alloy wear debris and resultant localised tissue discoloration.” It recommends that surgeons perform routine clinical follow up and discuss potential clinical implications and risks with patients who received affected rods. The decision to remove the device should be made by the physician in consultation with the patient and/or family.
We understand that the number of children affected is under twenty and hopefully, that is correct. We also understand that these patients are being contacted presently by their treating surgeons.
There is no doubt but that medical devices such as these Titanium rods can be, and are, life changing but there is a need for stronger legislation of the medical device industry in Ireland. Indeed, we have highlighted this need in previous blogs.
Contact us at Cantillons Solicitors at +353 (0) 21 4275673 or [email protected] if you would like more information.
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