Great Ormond Street patient can't get MAGEC spine operation

Harry Bridgeman, 11, has scoliosis – which means his spine is growing curved instead of straight – for which he has been treated by Great Ormond Street Hospital since he was a baby.

Five years ago, he was fitted with a spine-straightening metal rod – known as a MAGEC rod – that required no ongoing surgery.

But now it needs replacement, he and his family, from Hampton, have been told the NHS is no longer offering it – even though it remains in use across Europe and the USA.

They have been told Harry must instead be fitted with a different device – called a Harrington rod – which will require him to undergo two operations per year until his late teens.

“The Harrington Rod will require a lot more operations and recoveries, which will mean taking time off school every six months,” said Harry.

He is one of dozens of spinal patients at Great Ormond Street in the same situation, his mum Natalie said, leaving the hospital’s service “under pressure”, with longer waits for operations.

The hospital declined to make any on-the-record statement.

Harry Bridgeman and his parents, Chris and Natalie, have been told the rod currently being offered to child scoliosis patients requires two surgeries per year until adulthood (Image: Charles Thomson)

Safety concerns

Both the Harrington and MAGEC rods are extendable, meaning they can be elongated after being implanted, keeping up with a child's growth.

But whereas the Harrington requires two operations per year to keep extending it, the MAGEC is extended using magnets.

It was a pain-free, half-hour procedure every six months, said Harry.

His was fitted in 2019. Some  concerns had been already raised about the rod by then, as there were reports of them breaking inside patients years after being implanted.

But, said Harry and his parents, Chris and Natalie, experts told them the MAGEC rods were still the preferable treatment.

In 2020, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) began investigating concerns about the rods, after which they were withdrawn internationally.

Harry’s rod has now broken.

But, said Chris, they had "five good years" out of it, during which Harry would have had to undergo another ten operations if he'd had the Harrington.

The broken rod isn't causing any pain or discomfort, it just means it can no longer be extended as he grows – so a replacement rod is required.

Chris Bridgeman said it was frustrating that Harry and other children with similar conditions could not get the MAGEC rod, even though it has been reinstated across Europe and the USA (Image: Charles Thomson)

What’s the delay?

Since it was internationally withdrawn, MAGEC’s manufacturer NuVasive Specialized Orthopaedics (NSO) has made changes.

MAGEC rods are now back in use in many countries – but not the UK.

According to Natalie, the manufacturer and the MHRA have each blamed each other for the hold-up in their communications with her.

“I don’t believe that the manufacturers are holding it up,” she said. “It’s in their interests to get it back into the UK. It doesn’t make sense.”

“I appreciate that it has to be tested properly but it seems that the UK is so far behind everywhere else,” added Chris.

“The real frustration is that all the kids are left in limbo. It’s a fabulous bit of technology but it’s effectively sitting on a shelf doing nothing now… Everybody just blames everybody else.”

A 2022 survey of 18 UK spinal surgeons found 94 per cent of them felt the suspension of MAGEC rods “had a negative impact on the clinical management of their patients” and 100 per cent would use them again once reinstated.

Harry's mum Natalie said it didn't make sense that the manufacturers of the MAGEC rod would hold up the sale of their own product in the UK. She and husband Chris both believe the UK is taking too long to approve the rod's reintroduction (Image: Charles Thomson)

Responses

Manufacturer NSO did not respond to our press enquiry.

The MHRA’s chief safety officer Dr Alison Cave said: “We are actively working with the manufacturer of MAGEC to agree to a number of conditions to allow the safe return of the device back to the UK market.

“We are working to ensure that the long-term benefit of the device outweighs the risk and it is suitably monitored to enable us to quickly identify safety concerns.”

Meanwhile, Harry and his parents face a dilemma: Do they accept the Harrington rod, or wait to see whether the MAGEC is reinstated?

“Short-term, the Harrington Rod would be better,” Harry explained. “But long-term, MAGEC would be better. It might be a long wait, but it’d only require the one-off surgery.”

“It’s one thing reinstating it, but then it’s another thing to roll it out,” said Natalie. “Even if they approved it this week, we’d probably be looking at another six months.”