The global recall of a spinal implant – with recommendations from the manufacturers for patients to undergo urgent X-rays – may lead to thousands of people in the UK needing complex surgery to remove the device, which has now been linked to significant bone loss, reports The Independent.
The M6-C artificial disc implant was designed to replace damaged neck discs, offering an alternative to spinal fusion surgery, involving metal rods.
However, the implant has been associated with osteolysis – a progressive condition where bone tissue is destroyed and reabsorbed by the body.
Device manufacturer Orthofix had announced it would discontinue the M6-C disc in February 2025 – and while Australian regulators had already issued a hazard alert due to concerns about bone loss associated with the M6-C disc as early as 2020, British patients were not updated until six years later.
Law firm Penningtons Manches Cooper said it has been contacted by at least 10 people who have had the implant, with lawyers concerned that thousands more could be affected.
It is now exploring if a legal claim is possible against the manufacturer.
Sophia Harrison (52) from East Sussex, had the implant fitted in 2019. Two years later, she went to see her surgeon complaining of pins and needles in her hands, and simultaneously noticed a lump in her throat that was affecting her voice and swallowing.
She said she did not realise the two issues were connected.
After receiving a letter from the Medicines and Healthcare products Regulatory Agency (MHRA), she went for a CT scan that checked for osteolysis, which also showed a large mass which turned out to be a 10cm abscess.
“My doctor said he nearly fell off his chair looking at the results, as the infection continued to grow despite being drained. I can feel it growing again by the day and I’ve now been told they may have to take out two further discs, along with the implant, and insert a metal rod.”
In January, the MHRA flagged the device’s links to the risk of osteolysis and said those with the implant should have annual routine monitoring.
Harrison said: “I am so angry that we weren’t told about the faults of the disc leading to bones disintegrating.
“It’s absolutely despicable… the manufacturer would have known about this so why has it taken so long?”
Lyndsey Skibinski, a specialist medical negligence solicitor at Penningtons Manches Cooper, who is advising Harrison and leading the investigation for other implant patients, said: “This is a potentially huge public health issue with thousands of patients affected.
“Most of the people approaching us have had the implant in place for between eight and nine years but it is crucial that anyone who has this implant gets a scan to identify any problems and continues with recommended annual monitoring.
“Many will need complex surgery to remove the implants which poses the risk of paralysis or long term chronic pain.”
Dr Stephanie Millican, deputy director of benefit risk evaluation at the MHRA, said the regulator started an investigation into the M6-C device after reports in early 2025.
“The MHRA found there was a delay in the manufacturer’s communication of the risks of osteolysis to users and patients in the UK,” she said.
“The MHRA has advised healthcare professionals that patients implanted with the M6-C artificial cervical disc should be told of the risks of osteolysis, receive annual routine monitoring, and discuss the need for further investigation and continued follow-up.”
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