Insight: Down but not out after mesh implant '˜whitewash'
Along with hundreds of other women in Scotland – and tens of thousands across the world – Holmes and McIlroy suffered devastating complications after the mesh implants were used to treat Stress Urinary Incontinence (SUI), a problem common amongst middle-aged women.
“When mesh goes wrong it goes seriously wrong,” says McIlroy. “There are women losing their bladders, losing their kidneys. They don’t have a life. The life they had is totally gone. They cannot walk, they cannot sit without pain.”
Today, the women have come to a Beefeater restaurant in East Renfrewshire – Holmes in her wheelchair and McIlroy on her crutches – to talk about the Scottish Government’s defence of a “whitewash” review into what has been described as the biggest medical scandal since thalidomide.
The women are not overly keen to share their own experiences. Holmes, the more severely affected of the two, finds it overwhelming to reflect on her life before and after. But given the report – published last week and written in the dispassionate language of the bureaucrat – provides little insight into the human impact of mesh gone wrong, it is important to capture the extent of their ordeal.
Let’s start with Holmes. After she underwent her procedure in 2011, she woke up in so much pain she couldn’t move. Though the surgeon initially played down her symptoms, it transpired the device had sliced through her urethra. Holmes was bedridden for 14 weeks, and endured several more operations, and many more hospital admissions before she regained any mobility. Six years on, she can’t drive or get in and out of a bath and can barely walk. When she tries, her left leg often gives way and she falls. Holmes suffers from fibromyalgia which causes chronic pain and affects her concentration. Her husband Jeff has retired and become her carer. Thinking of the plot of land on Colonsay they once dreamed of owning makes her cry.
McIlroy, who loved hillwalking and going to the gym, suffered groin pain for a couple of years after she had her operation in 2008, then woke up one morning unable to move. She was forced to give up her job as a home carer and, like Holmes, is in constant pain. She has given up on the heavy duty analgesics with made her feel like a zombie, and resorted to mindfulness and a TENS machine.
Neither McIlroy nor Holmes were warned of the risks. “We were told: ‘This is a 20-minute operation. You’ll feel like a new woman,’” says Holmes. Nor were they told the mesh implants were for life. “I thought it was like the contraceptive coil. I’d give it a go, and if it didn’t suit me I’d have it taken out,” says Holmes. “When I found out it was permanent, I gret for days.” Holmes has now had almost all of her mesh removed, but because it fragments inside the body, the process is tricky: like taking chewing gum out of hair.
Both McIlroy and Holmes were told their problems were “unique”; it was only once they met that they realised they were nothing of the sort. Finding each other was the best thing that could have happened to them. Though they have very different personalities – Holmes is ultra-organised, while McIlroy “thinks outside the box” – they make a formidable team.
For the past three years, the pair have fought side by side to raise awareness of the dangers of mesh implants, giving evidence at the Holyrood Petitions Committee, successfully lobbying the Scottish Government for a moratorium on their use and joining the independent review group.
They attracted cross-party support from the SNP’s Alex Neil, Labour’s Neil Findlay and the Tory Party’s Jackson Carlaw and helped produce leaflets setting out the risks of all transvaginal mesh procedures, so, in future, women could make an informed decision on treatment.
Yet now, Holmes and McIlroy are facing renewed devastation. The review, in which they invested their energies, has fallen so far short of their expectations they no longer wish to be associated with it. Defended by Health Secretary Shona Robison last week, its final report does make a series of recommendations. It says mesh should not be offered routinely for prolapses and calls for the reporting of “adverse incidents” – cases where women suffer complications – to be mandatory, in accordance with General Medical Council guidelines.
But the campaigners insist damning evidence of the dangers of mesh has been left out, or hidden away in annexes and appendices, that no mention has been made of the cases currently being settled in the US, and that at least one of the recommendations has been watered down.
The Scottish Government insists it cannot ban transvaginal mesh as the Medicines & Healthcare products Regulatory Agency (MHRA) is the body responsible for such judgments – though some challenge this contention.
Instead, the report paves the way for the moratorium – which was, in any case, breached by several health boards – to be lifted once “safeguards” have been put in place.
Its “shortcomings” came as no surprise to McIlroy and Holmes. Though, in the beginning, they worked constructively with the other members of the group and signed up to the interim report (albeit with some reservations), they eventually lost faith in the process.
For ten months, they say, they were invited to no meetings, although they later found out “sub-group meetings” had been taking place, and the tone began to change. After the departure of the chair Dr Lesley Wilkie, and one of the clinicians, they too decided to resign. “When we told the women [in the Scottish Mesh Survivors Group], the mood hit the floor,” says McIlroy. “But they understood why we couldn’t put our name to a report that was a betrayal of everything we had worked for.”
Transvaginal mesh has been commonly used in the treatment of both pelvic organ prolapses (POP) and SUI since the early 2000s. Studies suggest traditional procedures involving native tissue repair is just as effective, but using synthetic mesh is quicker and cheaper, and the surgeons require less expertise.
In Scotland, between 2000 and 2014, around 1,500 women a year underwent the treatment, which has been presented as the “gold standard” for SUI. But mesh shrinkage and mesh erosion are not uncommon. Long-lasting side effects include abdominal and pelvic pain, urinary problems, painful sexual intercourse, vaginal scarring and nerve damage.
One of the difficulties for researchers is that symptoms may not emerge for a decade, making studies based on a five year follow-up of limited use. But some reports suggest the risk of suffering serious complications could be as high as 15 per cent.
For the treatment of SUI, two different approaches have been used: transobturator and retropubic. Of the two, transobturator (the procedure McIlroy and Holmes had) is more controversial because it is more difficult to remove the mesh once implanted. However, complications exist for both procedures and removing the mesh does not necessarily mean the pain will stop.
Globally, the continued use of transvaginal mesh is shaping up to be a scandal greater than those involving metal-on-metal hip replacements and PIP breast implants. In the US, hundreds of thousands of women are currently taking cases against manufacturers, with more than £1.5 billion already paid out in compensation. Two of the manufacturers are Endo and Johnson & Johnson-owned firm Ethicon, both of which make devices used in Scottish hospitals.
Rather than comply with requirements to provide long-term safety studies, a number of mesh manufacturers have withdrawn implants from the market, citing “business reasons”. There are also currently three criminal investigations into manufacturers in the US and thousands of women in Australia and New Zealand involved in class actions.
In January, the US Food and Drug Administration upgraded the classification of trocars – the hooks used to push mesh implants through the pelvic cavity – from II (moderate to high risk) to III (high risk) in the wake of research suggesting they cause injuries in almost 40 per cent of patients. The EU is upgrading the classification on all permanent transvaginal mesh from II to III. Yet, nowhere has its use been outlawed.
In Scotland, then health secretary Alex Neil suspended mesh procedures for the duration of the independent review. But several health boards, including NHS Glasgow and Clyde and NHS Lothian, defied the moratorium on the grounds the Scottish Government had said the procedures could still go ahead if the symptoms were severe and the women had given informed consent. About 400 such procedures (some of them involving transobturator tape) are believed to have been carried out in that time, with a proportion of those women also suffering complications.
In Scotland, around 420 women are involved in civil litigation, with more coming forward every week. Thompsons solicitors are representing just under 200 of the women, three of whom had synthetic mesh implants after the suspension had been instituted. The action is being brought against both the manufacturers and the health boards and will be heard in the Court of Session.
“It is one of the largest scandals in the NHS in Scotland – and we are only seeing the tip of the iceberg so far,” says Patrick McGuire, a partner at Thompsons.
He believes the Scottish Government is being disingenuous when it says it cannot ban the mesh because the power to do so lies with the MHRA.
“I think there is some political obfuscation going on. Yes, it is up to the organisation to decide if mesh implants are legal and ought to be available to use across the NHS, but health is a devolved matter and firmly under the direction of the Scottish Health Secretary,” he says. “Irrespective of what the MHRA says, if the view is taken that there are products it is not in the best interests of Scottish people to use, it is firmly within Shona Robison’s power to tell consultants to stop using them.”
McIlroy and Holmes are involved in civil litigation through Drummond Miller, but say their priority has always been to protect future patients.
One of their greatest concerns is that the issue of informed consent is still not being taken seriously enough by health boards. Despite working hard to draw up the booklet outlining the risks, some members of the Scottish Mesh Survivors Group found out-of-date leaflets on display in several hospitals years after they should have been replaced.
And McGuire says he has evidence some consultants are still encouraging patients to undergo risky procedures. “We have spoken to two women who, as recently as this year, met with consultants and were very clearly directed – without any explanation or alternative choice – towards mesh,” says McGuire. “Fortunately, they had heard about mesh and knew enough to question this advice. After further discussion they decided not to undergo any surgery. But this shows that – despite reassurances that mesh is now only being used in very limited circumstances and with very clear informed consent – the experience of these clients is quite different.”
McIlroy and Holmes are also upset that, while the interim report expresses specific concerns over the transobturator approach, the final report merely suggests that the retropubic approach should be recommended.
As for the conclusion on mandatory reporting of adverse incidents, the women accept it as a mini-victory but ask how such a move will be enforced? Unless there are sanctions, they say, it will be largely meaningless.
The publication of the report last week was greeted with disappointment not only by Findlay and Carlaw, but by Neil, who said the loss of faith in the process was unsatisfactory and needed investigating. “I do not think that we can leave it there, for the sake of the credibility of the report and its recommendations and for the sake of future reviews of this kind,” he said.
Issues that could be addressed include the imbalance of power between victims and experts in such groups, why the clinician resigned and why his evidence was not included in the report.
In the meantime, the Chief Medical Officer Catherine Calderwood has written to health boards with strict instructions on when mesh implants can be used and an oversight group has been set up to ensure the recommendations are implemented.
Back in the Beefeater, McIlroy and Holmes are struggling with a sense of failure. But deep down they know what they’ve achieved. The Scottish Mesh Survivors group has brought solidarity and friendship to women who were struggling to cope with the terrible limitations mesh-related symptoms have placed on their once active lives.
And they have raised awareness so that – the lack of a ban notwithstanding – women are now more likely to take stock before undergoing the same procedures.
“Some of the girls emailed last night. They wrote: ‘We’re down but not out – we look forward to seeing Cagney and Lacey back in the precinct’.” says Holmes.