Major review into health scandals

Prime Minister Theresa May’s sudden decision last week to review official responses to women left crippled by implanted surgical mesh is of little comfort to Dorothy Byrne.

Dorothy is one of thousands of women who have suffered life-changing problems as a consequence of the use of the little-tested plastic mesh, introduced to treat incontinence or support pelvic organs, typically following damage related to childbirth.

While many women have had no problems with the mesh, in others, for reasons unknown, it’s disintegrated, forming splinters that ‘migrate’, setting up chronic inflammation and causing infection around affected tissue.

In some women the material has damaged bladder and bowel function, or even their ability to walk.

 Just before Christmas, Canadian Christina Brajcic, 42, who chronicled her struggle with mesh-related infections that were proving resistant to treatment, died from sepsis.

Dorothy is now seriously ill with heart failure that she’s been told is linked to the chronic infections she suffered as a result of the mesh. A former NHS psychotherapist, she says she reported her problems to the devices watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA). But like others who say reports of their problems were ignored and never recorded, Dorothy, 65, maintains she has ‘never even received a reply’ from the body.

It’s not just the authorities — many women say doctors insisted they were imagining their problems.

In a victory for the Mail’s seven-year campaign highlighting problems with the mesh, Mrs May announced a review into handling of complaints about it.

The review, to be led by former Conservative health minister Baroness Julia Cumberlege, will also look at similar patterns of official inertia in response to concerns about the drug sodium valproate, prescribed for epilepsy, bipolar disorder and migraine. An estimated 7,000 women have given birth to damaged babies since the Seventies as a result of being prescribed the drug, and campaigners claim the authorities knew about the risks but failed to warn women.

The review will also take in the response to a third crisis, involving Primodos, a defective hormone-based pregnancy test used by 1.5 million women in the UK throughout the Sixties and Seventies, now being linked to catastrophic damage to foetuses of those who were pregnant.

Campaigners have called it the hidden thalidomide. The common thread between mesh and the two drug scandals is a long-term unwillingness by health authorities to acknowledge a problem, with the consequence that more women became victims.

Last week the Prime Minister acknowledged this, saying: ‘We do need to see a faster, more understanding response to patients when they raise concerns.’

But these three scandals reflect a greater problem with repeated controversies surrounding defective medical devices and drugs in the UK, such as industrial silicone being used in breast implants, defective metal hip joints that poisoned patients and faulty heart defibrillators. These scandals have raised serious questions about how such devices are monitored — and licensed in the first place.

The MHRA, along with other healthcare regulators around Europe, relies on a network of 59 commercially run ‘notifying bodies’ to approve the safety and efficacy of medical devices.

But as Good Health has reported, the notifying bodies are paid by manufacturers to win approval for their products and the requirements for scientific validation are vague, say experts. Baroness Cumberlege has said she looks forward to undertaking the nine-month review. ‘It’s essential voices are properly heard and that the system learns lessons and makes changes,’ she says.

But for some women whose lives have been destroyed by the mesh, it’s too little, too late. Not least because their cases have dragged on for so long that they’ve run out of time to seek legal redress.

Although she welcomes the review, Kath Sansom of pressure group Sling the Mesh, which has 5,600 members, says many of the women on her database were fobbed off for years by mostly male gynaecologists, who told them their health problems were nothing to do with the mesh.

‘These women are now time-barred from making legal claims,’ she says. ‘Meanwhile, this material is still being used and women are continuing to suffer. In the past hour, I’ve been contacted about a woman rushed into A&E with life-threatening sepsis and another begging for help who says she is on the verge of taking her own life because of the pain.’

Sadly, the review won’t help Dorothy Byrne. ‘My heart has continued to deteriorate because of a series of chronic infections as a result of the mesh,’ she says. ‘They started about a year after I had the surgery, in 2009, and continued more or less continuously until 2013 when I had it taken out. By then the damage was done.’

Dorothy, a mother of two adult children from Seaford, East Sussex, has heart failure caused, she’s been told by her doctors, by the infections she’s suffered.

She is currently in hospital waiting for a heart valve replacement. Like any surgery, it carries risks — an awful irony, given that she’s only in this situation because of her mesh procedure.

Unlike most of the other women who have been victims of the treatment, Dorothy says she did not even need the mesh: ‘I did not have stress incontinence — I had a prolapsed bladder. My consultant said I should have the mesh in case I developed incontinence.’

By the time Dorothy had the mesh removed in 2013, she had endured long periods of treatment for repeated infections linked to the mesh.

She’d also developed heart problems — in 2012 she had needed specialist treatment for sepsis in a high-intensity cardiac care unit. But doctors dismissed her suggestion that her heart problems could be related to the mesh. Her heart continued to deteriorate, and after she switched cardiology teams, she was told her problems were linked to her infections

‘By the time I found a specialist surgeon with the skills to remove the mesh, I was profoundly ill. The surgeon described my reaction to the tape as one of the most toxic she had ever seen.

‘I reported all this to the MHRA but I never even received a reply.’

For veteran anti-mesh campaigner Teresa Hughes, 66, from St Helens, Lancs, the new review is a hollow promise. She has been left crippled and unable to walk after having the mesh implanted almost 14 years ago in 2006.

Repeated attempts to remove the fragmented material from her body have been only partially successful. ‘I have been trying to get this issue on the agenda for such a long time,’ she says.

‘I went to medical conferences to tell doctors about the damage being done. I was moved on by police from outside the MHRA in 2011. I lobbied David Cameron in 2012. I doubt the review will go back far enough to include the damage to people like me.’

Some campaigners also fear the review could end up as a whitewash, pointing to the example of previous reviews.

It is estimated 92,000 women have had the mesh implants since they were introduced in the early Nineties as a cheaper alternative to pelvic repair operations, which involve the patient’s own tissue. Studies have suggested anything between 10 and 40 per cent of patients have suffered damage.

However, a review of the issues by NHS England published last summer did not discuss the safety of the mesh itself, but merely said doctors without special training should no longer use it.

A similar review was carried out in Scotland, where 1,500 women claim they have been damaged by the mesh. The findings of that review, announced last April, that the mesh was essentially safe was dismissed as a whitewash by campaigners. A new review is now underway in Scotland.

Kath Sansom’s concern about the review announced last week is that the ‘bigger problem’ is that the mesh was approved by an MHRA ‘which is not fit for purpose — while many of the women’s complaints have never even been recorded by the MHRA, which is largely funded by drug and device manufacturers.’

When asked, an MHRA spokesperson said: “We protect and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research. Our role is not to protect industry interests. We have a full and transparent conflicts of interest policy which means that our staff cannot hold any interests in the pharmaceutical industry during their employment with MHRA.

Kath’s views are echoed by Mark Harvey, a lawyer for Hugh James solicitors in Cardiff who is representing more than 100 of the 600-plus women expected to launch multi-million pound claims for mesh-related injuries.

MHRA chief executive Dr Ian Hudson told Good Health: “It is important to review and learn from how the healthcare system and regulators have handled these three issues, including how we ensure the patient voice is carefully heard. We will work closely with DHSC, the NHS and the wider healthcare system on this review. By all parts of the healthcare system working together, we can ensure patients are listened to and their concerns are addressed.”