Thousands of individuals in the United Kingdom may face complex spinal surgery due to safety concerns surrounding the M6-C artificial disc, a widely used spinal implant that has been withdrawn from sale. The device has been linked to osteolysis, a condition where bone tissue is progressively destroyed and absorbed by the body. Patients who received the implant, designed to replace damaged discs in the neck as an alternative to spinal fusion, are being recalled for urgent scans.
Manufacturer Orthofix announced in February 2025 that it would discontinue the M6-C disc after its global sale was halted. Lawyers at Penningtons Manches Cooper report being contacted by at least 10 patients, but estimate that thousands could be affected. The firm is investigating legal options for those experiencing trauma and suffering, with potential complications including paralysis and long-term chronic pain.
One patient, Sophia Harrison, 52, received the implant in 2019. Two years later, she began experiencing symptoms including pins and needles in her hands, and a lump in her throat that affected her voice and swallowing. After receiving a letter from the Medicines and Healthcare products Regulatory Agency (MHRA), a CT scan revealed a large abscess. Harrison stated her doctor indicated the infection continued to grow despite drainage and that she may require further surgery to remove additional discs and insert a metal rod. She urged others with the implant to get scanned promptly to detect potential infections or related symptoms.
Regulators in Australia first issued a hazard alert regarding the device in 2020, citing concerns about bone loss. UK patients were informed of the risks years later, leading to anger among those affected. In January, the MHRA warned of the implant's link to osteolysis and recommended regular monitoring for patients. Harrison expressed anger over the delayed communication of the implant's risks, suggesting the manufacturer was aware of the issues sooner.
Dr. Stephanie Millican, deputy director of benefit risk evaluation at the MHRA, stated that the regulator began an investigation into the device in early 2025 following reports. She acknowledged a delay in the manufacturer communicating the risks of osteolysis to patients and healthcare professionals in the UK. The MHRA has advised patients with the implant to be informed of the risks, undergo routine monitoring, and discuss any concerns with their specialist. Patients are expected to be contacted by their surgeon or hospital, and individuals experiencing symptoms are encouraged to seek medical advice.