Thousands of people could face complex surgery to remove dangerous spinal implants. Patients with damaged discs in their neck were offered M6-C artificial implants as a safer alternative to spinal fusion, which uses metal rods. But the device has now been linked to osteolysis, a progressive condition where bone tissue is destroyed and reabsorbed by the body.
Patient Experiences and Legal Action
Law firm Penningtons Manches Cooper has been contacted by at least 10 people with complications. Among them is Sophia Harrison, 52, who had the implant fitted in 2019 and began experiencing pins and needles and a lump in her throat soon after. A CT scan later diagnosed osteolysis.
She said: "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."
Sophia added: "I'm speaking out as I want to raise awareness and tell people who have this implant to have a scan as soon as they can so that they can avoid what is happening to me. You may not even be aware you have an associated infection or other symptoms. I feel for all of the surgeons who are having to clear up the mess of the previous doctors who inserted these implants into patients."
Regulatory Delays
Australian regulators issued a hazard alert on bone loss associated with the M6-C disc in 2020, but the Medicines and Healthcare products Regulatory Agency (MHRA) did not notify UK patients for another six years. Sophia, of East Grinstead, East Sussex, said: "I am so angry that we weren't told about the faults of the disc that leads to bones disintegrating. It's absolutely despicable as the manufacturer would have known about this so why has it taken so long? If I had known earlier, the infection would have been caught and I would not be facing what has now become such complex and daunting surgeries on my spine."
Legal and Medical Concerns
Sophia’s medical negligence solicitor, Lyndsey Skibinski, 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."
She added: "Many will need complex surgery to remove the implants which poses the risk of paralysis or long term chronic pain. We are currently investigating the legal options open to those we are advising to see how we can secure justice for the trauma and suffering they are experiencing and also to recover funding for future treatment and rehabilitation."
MHRA Response
The MHRA’s Dr Stephanie Millican said: "The MHRA took these concerns seriously and found that there was a delay in the manufacturer's communication of the risks of osteolysis to users and patients in the UK. Patient safety is our top priority. We continuously monitor medical devices used in the UK to ensure they perform to the expected standards."
She continued: "The MHRA has advised healthcare professionals that patients implanted with the M6-C artificial cervical disc should be informed of the risks of osteolysis, receive annual routine monitoring and discuss the need for further investigation and continued follow-up. We encourage patients, carers and healthcare professionals to report any suspected side effects to the MHRA via the Yellow Card scheme."
