A women’s health campaigner has warned the health secretary that government plans to speed up the approval of new medicines is a “serious concern to patient safety”.  

Kath Sansom, a mum-of-two from March, raises awareness of the complications women around the world are experiencing from pelvic mesh implants.  

The use of mesh to address incontinence was suspended in the UK in 2018 – but it was previously considered a new and revolutionary treatment.      

Even though patients experienced excruciating pain and serious complications afterwards, surgeons were dismissing the reports as side-effects of any major surgery.  

Surgical mesh is made from polypropylene plastic and is also used for hernia repairs and in some breast reconstruction surgeries following mastectomy.  

"a disaster waiting to happen..."

Cambs Times: A pelvic mesh sling. The use of mesh to treat incontinence and prolapse was suspended in the UK in 2018.A pelvic mesh sling. The use of mesh to treat incontinence and prolapse was suspended in the UK in 2018. (Image: Newsquest)

Kath, from March, said: “We now know pelvic mesh implants had not undergone the scrutiny they should have done.  

“Complications from mesh can take years to manifest – and we’ll never know the true extent of the issue.  

“So if new treatments and medical devices are approved more quickly, well, it’s a disaster waiting to happen in my view, and a serious concern to patient safety.”  

In her most recent correspondence with the Steve Barclay, she tells him: “... we might as well park an ambulance at the bottom of a cliff and wait for harmed patients to fall in.  

“Then wait two decades for their voices to be heard.”  

The approval of new treatments and medical devices

Cambs Times: Health secretary Steve Barclay and The Chancellor Jeremy Hunt.Health secretary Steve Barclay and The Chancellor Jeremy Hunt. (Image: Houses of Parliament)

An independent inquiry in 2020 found the UK lacked adequate regulation and oversight when it comes to medical devices.  

The review was originally commissioned by Jeremy Hunt, who was then the health and care secretary, and the final report urged the government to address the issue.  

Instead, from 2024, new treatments and medical devices will be approved more quickly, and Kath is understandably concerned by what she describes as “a massive u-turn". 

And Mr Hunt, now in his capacity as The Chancellor, used the spring budget to announce reform to medical regulation.  

Kath reminded the health secretary: “[Mr Hunt] has consistently supported the review and indeed the findings of Baroness Cumberlege.  

“[These include] the failings of the Medicines and Healthcare products Regulatory Agency (MHRA) to properly regulate new treatments and a failure to respond in a timely manner when patients reported harm.    

“Fast forward to 2023 where Jeremy Hunt now says the MHRA is a worldwide leader in regulation.    

“It feels like a massive U-turn. It is a serious concern to patient safety and as a campaigner, feels like profits are being put before people.” 

"...swift new approval process" of medical regulation

In his budget speech, Mr Hunt explained how medical technologies already approved in other “trusted” parts of the world would receive “near automatic sign-off" in the UK from 2024.  

He said: “We are lucky with the MHRA to have one of the most respected regulators in the world, indeed the very first anywhere to licence a covid vaccine.     

“From 2024 they will move to a different model to allow rapid often near automatic sign off for technologies already approved by trusted regulators in other parts of the world such as the USA, Europe and Japan.”  

He added: “At the same time, they will set up a swift new approval process for the most cutting-edge medicine and devices to ensure the UK becomes a global centre for their development.” 

An extra £10m of funding has been allocated over the next 10 years to “put in place the quickest, simplest regulatory approval in the world for companies seeking rapid market access”.  

Mr Barclay, who is also MP for North East Cambridgeshire, has been approached to comment. 

He has also not responded to Kath’s correspondence. 

"Sling the Mesh"

Cambs Times: Mesh survivors outside the Houses of Parliament in the early days of campaigning. Mesh survivors outside the Houses of Parliament in the early days of campaigning. (Image: Archant)

Kath, a former journalist for this newspaper, launched the “Sling the Mesh” campaign in 2015 with just 20 women.  

The Facebook page now has almost 10,000 members from around the world – including men who are suffering from hernia mesh complications.   

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Kath has also successfully campaigned to have a clause added to the Health and Social Care Act to uncover industry payments made to doctors.  

Thanks to her efforts, NHS specialist pelvic floor physiotherapy is being improved across England from March 2024, for women following childbirth and throughout their lifetime.   

In November, Kath received a “She Inspires” award in the National Agent of Change category.