The vaginal mesh scandal is the 'new thalidomide' – so where is the outcry?

The Mesh Oversight Group Report, in response to a 2015 interim paper and in conjunction with a March independent review in Scotland, came out this week – to address what’s being referred to by senior doctors as the most serious women’s health scandal since thalidomide: transvaginal mesh procedures.

And yet, barely a whisper in the headlines. And ultimately, a devastating blow to campaigners and victims. And a threatening precedent to women’s health in general.

The Mesh scandal

The transvaginal mesh implant (TVM) is a widely prescribed treatment for common complications following childbirth, such as urinary incontinence – leaks with coughing or sneezing – or pelvic organ prolapse, where the internal organs can bulge into the vagina.

A plastic mesh is blindly inserted into the vagina, or vaginal wall, with a set of hooks, and left there to support the womb. Functioning rather like a canvas grocery bag, and made of the same material that’s used to make drinks bottles. According to a 2012 government report on concerns – and yes, this has been on the radar a long time – the procedure is performed on about 15,000 women in the UK per year.

Side effects can range from chronic pain and loss of sexual function, to major complications like the implant protruding through the bladder, or bowels, even necessitating removal of organs ensnared in the mesh. It can shrink inside your body, slicing through nerve endings, tissue and organs.

The Medicines and Healthcare products Regulatory Agency (MHRA), the government medical devices watchdog, has received more than a thousand complaints, yet continue to maintain that there is only a 1-2 per cent risk. But Professor Carl Heneghan, director of the Centre of Evidence Based Medicine (CEBM), tells me that the real number of hospital re-admissions is closer to 19 per cent, depending on the procedure.

Dr Sohier Elneil, a consultant in utogynaecology at University College Hospital, suggests that unpublished research by her team puts the number at 9 per cent re-admission, for meshes to treat incontinence. And that’s just for serious complications.

Kath Sansom, a journalist and campaigner, had the procedure to treat minor and occasional stress incontinence in 2015, and began suffering severe symptoms 10 weeks afterwards. She tells me that the procedure was marketed as “a very simple and quick fix; perfect for busy working mums to be back at their desks in a week, with the risks very much downplayed”. She tells me of the constant pain: in legs, feet, groin, bruising – and private parts “burning so badly it’s like someone has poured a bottle of chilli sauce inside it”.

“For some women,” she says, the mesh “literally slices clean through their vaginal walls – so not only does that hurt, but it cuts their partners during sex. Want to know what surgeons give to try and fix this? Ovestin cream – what a joke.”

Kath began to research the procedure, and stumbled upon a huge swathe of fellow victims. In response, she started the Sling the Mesh campaign, to try and raise awareness of the risks. At the moment, 500 patients in Britain are in legal action against mesh manufacturers, and up to 2,000 are planning to sue: particularly Johnson & Johnson, a high-profile manufacturer of the device.

In America, there are over 100,000 women currently in litigation. Over there, it’s been upgraded to a higher-risk device, after the FDA issued a public health notification on serious complications back in 2008, citing that the hooks can cause injury to up to 40 per cent of women. Politicians in Scotland, including the former Scottish Health Minister, called for operations to be suspended all the way back in 2014. And yet, there were no such calls in England, Ireland or Wales.

There are around 100 different types of mesh implants are still available on the NHS; to date, not a single one has been recalled. MHRA has found “insufficient evidence” to justify a ban.

So the report: two years in the making; 10 years in the campaigning; eagerly awaited by politicians and medical professionals who called for a public inquiry, and desperately anticipated by thousands of women suffering chronic pain, serious physical and sexual complications, as well as loss of quality of life. And the official proclamation from the NHS on the use of “barbaric” transvaginal mesh on women – which offers no hint of change in medical policy, admittance of culpability or offering of apology.

In response to its publication, Labour MP Owen Smith has publicly stated that women will be “extremely disappointed by the outcomes of the final review, which seem to have made little progress since its interim report came out over a year ago. The only people pleased with this report will be the medical device companies who marketed mesh so diligently, and who now fear mass litigation.”

There are so many facets to this story: commercialisation of the medical device market that financially incentivises procedures, and poor regulation that allows the untested devices on the market in the first place. Lack of funding or trained medical professionals for alternative procedures. Shame, stigma, sexism, and a lack of value on female sexuality. How was this allowed to happen?

The report also effectively whitewashes the most important issue. There is a stunning lack of knowledge or care about the psychosexual side effects of vaginal surgeries in general – and an inherently misogynistic devaluation of a woman’s sexual fulfilment.

Simply put: sexual damage to women is not only not known about as a side effect of surgery; it's also not considered to be a serious one.

The Background

Professor Heneghan, also a GP and an expert in device regulation, explains how the mesh made it on to the market in the first place – without proper trialling or long-term clinical data.

The protogen was brought out in 1996, and approved with some short-term trialling. In 1998, serious concerns emerged, so they withdrew it from the market; however, during that two-year time period, several other similar devices had been already approved, which were not withdrawn.

And how? To get a medical device approved, you can go to any notifying body across Europe and be given Conformité Européenne (CE) accreditation. Once the device is approved in one EU member state, it’s automatically approved across all of them. The process also allows you to use the concept of ‘'substantial equivalence'’: if your device is similar enough to others already on the market, you can get approval without clinical trial data – just a literature review of existing evidence, and some animal testing.

And unlike a drug approval, which requires a phase 1, 2, and 3 randomised human trial to establish benefits and harms, there is no such regulation for medical devices.

Any clinical trial data is short term – three to six months, usually. Not nearly enough time for a proper investigation into the long-term implications of surgical procedures.

And in fact, Professor Heneghan says, most of the clinical trials follow after the device has been on the market for some time. “It’s the loophole everybody’s missing,” he says. “These devices are used prior to establishing they’re safe, and that’s where there’s been a catastrophic and complete failing of device regulation.”

To prove this, in 2015 Professor Heneghan agreed to produce a fake report for Jet Schouten, a journalist with Dutch consumer television programme Radar, about the advantage of netting used as a surgical aid – the kind of netting used to carry oranges. As reported in The Sunday Times, they were told there would be ‘'no problem'’ getting it approved.

There’s also a lack of funding or availability for more appropriate non-surgical treatments, such as pelvic floor physiotherapy, which in France is a standard after women have babies. It’s estimated that these could help 60-80 per cent of women, who would then not have to endure more invasive surgical procedures, and all their possible complications.

Dr Elneil, Kath Sansom and all the gynaecologists I spoke to also explained that women are encouraged towards 'quick fixes' like the mesh, over more time-consuming, traditional procedures like the burch colposuspension or the autologous sling, which can take up to four hours, followed by a few nights’ stay in the hospital.​

Ultimately, says Professor Heneghan: “It boils down to baseline profits for the big medical corporations. Commercialisation is a huge issue – the amount of money being made by individuals or companies. Most of these women are starting asymptomatic, with a small prolapse. These devices are costing thousands pounds.”

The report

In response to the report, the MHRA released this statement from John Wilkinson, director of devices: “In common with other medical device regulators worldwide, none of whom have removed these devices from the market, we are not aware of a robust body of evidence which would lead to the conclusion these devices are unsafe if used as intended.”

Not aware. Therein lies the crucial point that the report has missed: the lack of proper data for side effects.

It uses evidence of rates from Hospital Episode Statistics, but the problem with using HES data in this way is that if a woman has complications, and she goes to her GP, but not the hospital, then she is not included in the stats. Many side effects which are reported, aren’t included in the report.

And what of those who were ignored? Women, such as the 100 that attended the parliamentary meeting on 18 July to discuss the issue, have spoken of “not being listened to” and feeling “consistently dismissed”. As Dr Elneil says: “There’s definitely a gender issue about it: a lot of women are just expected to carry on; many are told that it’s nothing serious.”

There are also potential conflicts of interests at play: some of the surgeons in some studies may have been paid by Johnson & Johnson with a research or fellowship grant. Another issue is the focus on the immediate success of operations, rather than on long-term effects. For many women, these procedures do work to treat prolapse or incontinence; they just do damage elsewhere.

As Sansom says: “We’re not debating efficacy. But my God, it has some hideously catastrophic impacts on quality of life.”

And what of those side effects which aren’t reported? Shame, ignorance, lack of self-care or awareness of what’s normal...these are all issues surrounding women’s health in general, and the vagina in particular. Many women still feel too embarrassed to discuss sexual problems in any medical capacity, or even admit them to themselves.

Twenty years ago, even speaking about incontinence and prolapse was taboo. And, says Dr Elneil, “It’s only recently sexual function is something we discuss face to face on a regular basis. It’s the last of the taboos coming to the fore.

“For women generally there’s a tendency – especially with issues regarding sexual function and the vaginal area – to be told to just get on with it. Think back to mothers and grandmothers – it was expected that you would have incontinence and prolapse when you have children, and you should just live with it.

“Also, there’s a tendency for women being busy people in life – they put themselves at the back of the queue. It’s usually their children first, and husbands after that. Then they get to a certain stage in life when they feel their responsibilities for others have been addressed, and they can address their own issues. By that time, they will have suffered in silence for years.

“And there’s a thought that if there’s nothing horribly wrong, they’ll ignore it. More sinister symptoms like chronic discharge or bleeding will make them go to the doctor, but pain or discomfort during sexual intercourse – that they’ll tend to forgo.”

It seems that the report shares this mentality. Nowhere on the included leaflet about improved guidelines is there any mention of the psychological side effects and damage to sex life that women can experience. But Sansom tells me: “Half the women I spoke to [who had received a mesh] said they felt they been sexually neutered.”

Trialling on animals certainly wouldn’t have taken into account any effect on sexual fulfilment. A rabbit, sheep or dog can’t tell you that they’ve lost sexual function.

The other surgeries

This has far wider implications for vaginal and gynaecological surgeries. Mr Amer Raza, a consultant gynaecologist at the Lister Hospital, tells me: “In my experience, many women suffer with consequences of vaginal surgery (whether an elective plastic surgery or unpreventable perineal tear in vaginal delivery) silently, for a long time.”

Any operation, be that vital hymen repair procedures, episiotomies, or any other vaginal surgery, is associated with some post-operative pain. But crucially, any surgery in that area also has a psychological and anxiety-related relevance, which can result in long-term sexual dysfunction. That’s not a side effect that is ever discussed.

Memory of trauma to the area, even after the pain has worn off, also has the potential to result in the serious condition of vaginismus - the involuntary tightening of the pelvic floor muscles as a result of psychological anxiety. It makes penetrative sex extremely painful, if not impossible.

It's thought that roughly two in 1,000 women - although the real number is likely to be significantly higher - suffer from the condition, which is notoriously difficult to treat, because of the combination of physical and psychological elements.

Sometimes, doctors even prescribe botox injections into the vagina: a short-term, little studied process that is designed to temporarily weaken the vaginal walls, allowing the patient to break the cycle of anxiety and pain and achieve penetrative sex, as well as plastic dilators and vaginal pessaries of anaesthetic gel, all designed to train and numb the area.

What’s not offered is psychosexual counselling to address the underlying psychological distress. Because it’s not available on the NHS.

Dr Elneil was part of the team that first developed the use of botox in the bladder for overactivity, where trials were able to show good efficacy and safety. “But for the use of botox in treating vaginismus,” she tells me, “there’s not much evidence to suggest it’s a good long-term therapy, and therefore more robust trials should be done.”

And what of episiotomies – slicing between the vagina and the anus, to aid childbirth? Delivery is high speed and panicked; any prior discussions of long-term side effects are, by default, unlikely.

Mrs Pradnya Pisal, gynaecologist and senior consultant for the NHS, wonders: “Is loss of sexual pleasure considered an acceptable risk? Good question. I don’t think it is discussed well with patients as a long-term risk. I don’t think patients are well informed about what can result. There really isn’t much of a choice anyway – you either have to do an episiotomy, or a tear.”

And yet, many women suffer for decades following an episiotomy with chronic pain and sexual dissatisfaction.

And what about the psychological trauma of sexual dysfunction itself? Self-hate, shame, disgust, fear that a partner will never find you acceptable, fear of being unloved, damage to relationships...the list goes on and on.

As Sansom says: “It’s so embarrassing for a woman to talk about loss of sex life, and it’s almost as if medical professionals know that women will be too embarrassed to talk about it. Therefore, it can be massively downplayed within the risks.

“If there was the chance of a man losing their sex lives, there’d be absolute outrage.”

In 2017, is a women’s sexual fulfilment really such a minor consideration? If this really is a scandal on the scale of thalidomide, where’s the national outcry? When women don’t report side effects, or side effects go ignored, or those side effects aren’t even discussed as risks, how can you say due diligence is being taken?

When the deregulation of the medical industry – and nobody knows what will happen in that respect after Brexit – combines with commercialisation and funding cuts; when lack of understanding of long-term side effects collides with lack of importance of a woman’s sexuality, all in the most delicate, complex, stigmatised part of a woman’s body – we enter into a maelstrom of shame and pain, in which only women bleed.