First, Do No Harm? The Business Behind the Vaginal Mesh Disaster

This one is difficult listening at times, but it’s a story that needs to be told.

Dani and Si take a closer look at the vaginal mesh scandal, one of the biggest medical controversies in recent UK history, and a stark example of what can happen when systems fail the very people they’re supposed to protect.

What began as a seemingly simple solution for stress urinary incontinence and pelvic organ prolapse was promoted as a quick, minimally invasive procedure for thousands of women. Instead, many were left facing chronic pain, life-changing complications, loss of mobility, damaged relationships, and years of fighting to have their experiences believed.

We explore how vaginal mesh became widely adopted despite significant concerns, why so many women found their symptoms dismissed or ignored, and the role major manufacturers played in bringing these products to market. We also unpack the findings of the Cumberlege Review, which exposed serious failings in consent, reporting, regulation, and patient care.

Along the way, we discuss accountability, product liability, the slow progress towards compensation, and the campaigners who refused to stay silent. Most importantly, we examine the wider question at the heart of this story: what happens when profit, convenience, and institutional self-protection outweigh the responsibility to put patients first?

A powerful conversation about trust, transparency, and the women whose persistence forced a system to listen.

Proudly sponsored by Tina Engelmann

When it comes to pelvic health, too many women are told that leaking when they laugh, living with prolapse, pain during intimacy, or struggling after birth is simply something they have to put up with. Tina Engelmann as a C-Section & Hysterectomy Transformation Coach is on a mission to change that. Tina is the top specialist in C-section recovery and pelvic floor health, she helps women understand what’s really happening in their bodies, busting myths and providing evidence based support for issues including incontinence, prolapse, pelvic pain, and postnatal recovery.

Through her educational content and practical guidance, Tina is helping women feel informed, empowered, and confident in seeking the support they deserve.

To learn more, visit c-sectionrecovery.co.uk and follow Tina's work on Instagram and Facebook for expert advice, myth-busting insights, and practical support for your pelvic health journey.

About Simon and Danielle:

Simon and Danielle are both business owners, based in the East Midlands, who met through mutual business contacts and who share a love of all things business. 

Simon runs Skylight Media – Award-winning experts in Website Design, E-commerce & Marketing running since 2003.

Danielle runs Goldspun Support – a multi-faceted support service for fractional directors and small business owners across the globe, running since 2009.

Since they first met Simon and Danielle have spent a ridiculous amount of time talking about the subjects that interest them – usually over a drink in the pub – and they decided that now was the time to bring these conversations to a wider audience and invite them to join the chat. 

Both Simon and Danielle are successful business owners in their own rights with big plans for the future but will never lose their love of talking all things business… and the pub.

Transcript

Hi, I'm Dani
and I'm Si. Welcome to Business in the Brew, a podcast dedicated to Winfrey's business with the occasional cover.
We take a business story, theory, or something we just want to chat about, and debate a dusting of our own special personality and sense of humor, combined with our experience and knowledge. We're both business graduates and have run our own businesses for many years. We can't wait to listen, we Good morning,
good morning. I'm
so quite practical. We've
got a great day out there.
Well, it's not quite sunny yet.
Yeah, all right. I know we're in here.
I know,
right? Okay, this episode might make you a little cross if you don't know about it already. It's a little along the lines of the Dawcon Shield, which is an episode we did previously, and hip replacement scandal
between hips and vaginas.
Yes,
yes,
yes. Probably, if you haven't heard about this before as a listener, it might make you quite cross as well. It's actually a story of trust, and I kind of, even though I'm doing the talking here, this is a combined story, really, but I don't want to come across like I'm mansplaining a women's problem, but it's just happens to be a story that people just kind of should know about, if they don't know about it already, and it's about the trust that we place in our doctors, the medical system, and in the companies that make the devices, that's what we should be calling them,
but we should really, that sounds great,
yeah, that are implanted into our bodies.
Okay? Where are we implanting this
one? I'm coming to that. It's a story about how that trust was catastrophically betrayed, whether intentionally or not, and I think probably not. Initially, we're talking about the vaginal mesh scandal. It's also called the transvaginal mesh, or pelvic mesh, right?
I don't like the word mesh. Don't like it now.
Yeah, yeah, you know, it's gonna get pretty gross, but it's not, you know, it's not, it's not. This isn't about sensationalizing the story, but a lot of people don't actually know about it because it didn't affect them, or they don't know about it because they are out of time of what happened, because a little while ago, but it's still actually very relevant. There are a couple of scenarios, a woman, maybe in her 40s or 50s, I've had a couple of children and suffering from stress urinary urinary incontinence, yeah, okay, and that's
two kids, I'm very familiar,
sneezing, laughing,
yeah, it's not fun,
trampolines, yeah, so it's pretty miserable from from my understanding what I've read, and you, you know, I mean, you have to live with it and get on with, get on with it, but the another scenario is where someone's had a pelvic organ prolapse, and following things like hysterectomies, and the muscles that hold everything in together, and they've weakened, and the organs start to start to shift, right. So they were identified as problems that could be, could be dealt with, and in 1998 the NHS started offering a solution,
which is
great. It's a mesh, funnily enough. Yeah, it's a tiny implant, a net-like mesh. It's made of polypropylene stuff that fishing nets are made from.
Net says colander to me, which doesn't say stopping the problem, but I don't really know how it works.
It's more support
rather than capture.
No, no, no, no, no, no. This
is why I'm here to ask the questions. Everyone's wondering, so this is interesting. You know very little about it, which is good, which is good. So it's, it's, it's inserted vaginas to support the pelvic floor, right? Okay, it's a quick procedure, minimum recovery time, and the surgeons called it a global standard, and women were told it was safe, or as safe as it could be.
Well, I'd like to think that the hospital were putting it in you.
Yes, yeah, so for. For many women, that became utterly devastating on the mesh. This is the crucial thing: was never designed to be removed. It was in there permanently. Okay, right? So you kind of understand that actually, once it's in there, it's going to stay in there. That's supposed to be so, it's designed to be permanent, but for 1000s of women, it didn't quite sit well in the body, and it eroded, it hardened, and from what I've read, in literally within 60 days, it hardened.
I regret doing this first. It cut through tissue,
it migrated into other organs, so someone who perhaps was very physical, exercising, it may move around a lot more. Oh no, go there.
Sorry, this is important. Yeah,
there's no time for levity, right? So some women couldn't work, they couldn't have sex, they couldn't function because the pain was so great. One patient described it as being the best thing since sliced bread, when it was implanted, and then said her life was ruined.
Yeah, I literally feel like some journalists went to a right, you need to say something good, just say it's the best thing since sliced
bread, because
nobody
says that, everyone understands sliced bread,
but no one ever says that, there's never been a situation again, deal, or this is the best thing since sliced,
well, I'm not actually making a direct quote there, but so, yes, it was done routinely on the NHS, and over 127,000 of them were carried out procedures. Can
I ask a question? Did it actually do the job it was, you know, bar the whole falling apart, causing people pain and stuff? Did it actually do the job it was supposed to do?
Well, yes, but at what cost?
Okay,
yeah. So that was between 2008 and 2017 yeah,
yeah,
that was 127,000 that's the figures that I picked up, and then women started coming forward with complications, but when they did, they weren't believed.
All right, quick pause, because this one's genuinely important, if you've ever had a baby, whether that was a C-section or vaginal birth, a lot of women are told the same things afterwards. Leaking is normal. Your core will never be the same. Prolapse just happens. And because you hear it so often, you start to accept it. You get on with things, you adapt where you need to, and you carry on, even if something doesn't feel quite right. But here's the reality: common doesn't mean normal, and it definitely doesn't mean it can't be improved. Tina Engelman specializes in postnatal recovery and pelvic health. This is her area of expertise. She works with women who are dealing with things like wheat bladder control, prolapse symptoms, core instability, or just that feeling that something isn't quite right after birth. What makes her approach different is that she's not about quick fixes or surface level exercises. She's about rebuilding strength properly, helping you understand how your body works, how it's changed, and how to support it in a way that actually lasts. It's a more considered, informed way of working with your body, one that focuses on long term strength, not short term solutions, and gives you the confidence to feel in control again, because your body is capable of more than you've been led to believe. Sometimes it just needs the right kind of support. So, if something's been niggling at you, or you've been told something you just have to live with, maybe don't accept that. Go and check Tina out, because when you understand what your body is actually capable of, everything changes, was it hysteria?
We were told the pain was in their heads. Yeah,
that's right. I imagine pain all the time.
I mean, someone living with pain, they know where the pain is coming from.
Yes,
and they know the likelihood of where that pet, what has resulted, what, how that pain has resulted
a weird foreign object inserted,
yeah, but but the the reaction I've got is patients know best. I mean that is literally the phrase patients that patients know their bodies, and if something doesn't feel right, and actually
there are some exceptions to that, but yes,
it's since I had this thing fitted, and there's pain.
Yes,
then people have got to be listened to. They were sent back, though, to the very surgeons that implanted the mess in the first place, the
type of people who don't like to admit they're wrong.
Yeah, there was a review set up, the Cumberlege review. I'll come to more detail. They heard from women who said that they were gaslit at every turn, told their symptoms were imagined, told their marriages were the problem, they were dismissed, minimized, and sent away.
Your marriage has got an issue.
Yeah, yeah,
that's. Awful.
Yeah, so bring, because this is business in a brew. Yeah,
yeah, we're not just gonna be horrified. Let's bring this back
to the business side of the story. Yeah,
we must.
Biggest manufacturer was Johnson and Johnson.
Genuine, thought you're gonna make me guess. Then
our old friends, Johnson and Johnson, their subsidiary Ethicon, from my readings, and here's where it gets deeply uncomfortable. In 2019 a federal court in Australia, a judge in that court ruled on a landmark case involving 700 Australian women and found that Ethicon had conducted no adequate clinical trials on the devices before taking them to market. None, the products were implanted in hundreds of 1000s of women without proper safety testing, and Johnson and Johnson ended up paying 100 and $17 million in the United States to settle claims from multiple state attorneys general who found that the company had misrepresented or failed to in that it failed to adequately disclose the possible adverse effects to both patients.
Do you think that's one of those
things
we've talked about them before? When companies have a conscious choice between doing the right thing and doing the wrong thing, and then making a payout, and they felt it was cheaper just to pay out than it was to admit, and retrofit retrofit.
Yeah, well, what would you do? Yeah, so in the UK, the scandal played out a little differently, because of how consumer protection works. Women couldn't easily sue the manufacturers directly, and claims not to go through NHS trusts, which made it slower, harder, more adversarial, adversarial,
lot more red tape.
Yeah, I was an inquiry, the so, so the Cumberlege inquiry, that's Baroness Julia Cumberledge, which is a former health minister, Chad, what became known as the Independent Medicines and Medical Devices Safety Review. Yeah, I know. She published a landmark report in July 2020 called First Do No Harm.
That sounds really familiar,
because that's the Hippocratic Oath.
Why does that sound vaguely?
And the review, it was damning. It found the medical establishment had systematically failed women. The informed consent had been routinely absent. Many women were told that they were being implanted. They weren't told they were being implanted with mesh at all, just told they were having a tape procedure. Surgeons were performing the operations that hadn't been properly trained, complications were being under reported, and she, Baroness Cumberlege, said herself that she'd been appalled at what she'd heard.
I'm glad it was run by a woman, that would be extra insulting. If
absolutely, I mean, I feel awkward enough as a man, you know, telling the story, a very sensitive job of it, thanks. Yes, you're being less sensitive with your answers. It's
my job. I'm like, really,
progress has been made. It's been painfully slow, and still far short of what's needed in 2023 It looks like only 16 claims had gone through the NHS compensation gateway, and none resulted in any form of payout, but in 2020 440 women received what was believed to be the first successful product liability group action payout with claims against manufacturers Johnson and Johnson, Bard, and Boston Scientific, also other manufacturers, campaigner Cath Sansome of Sling the Mesh, which is website worth looking at to get the football, really full and accurate story. She's fought the battle since 2015 and she welcomed it, and noting pointedly that 140 women's is a tiny fraction of the 1000s whose lives have been irreversibly changed. The patient safety commission has since recommended a proper government redress scheme, though as yet that recommendation still has not been acted. Government kind of drags its feet on things like this, yeah. I know, I know, because everything's so carefully budgeted. Oh, we haven't got the money for that. We were going to get 20 million from for that, and then we go to war. So,
political pop.
I know it's not. I know, I know. Thanks for bringing me in. There, so things are moving, but nowhere near fast enough, and women are still waiting, and some estimates suggest up to 40,000 in England alone are watching that process with very, a very understandable mixture of hope and exhaustion. You could say the whole system let them down
here, go.
Them are they still not wearing, do they still have those things inside them?
Well, here's, here's a thing. Some women continue to suffer the pain. It's, I don't know the exact makeup of the thing, apart from it being polypropylene, but does that dig that degrades over time.
Well, most materials, yeah,
but
a hip replacement is changing,
yeah. Well, that's true. So the whole system let people down. Medicine regulation law, I'll come to that. Compensation, every layer of protection it should have caught this failed, and the Cumberlege report described it as an unwritten contract between patients and healthcare providers. First, do no harm, and concluded that the contract had been broken comprehensively. And what this makes this a business story as much as a health story is, is this a medical device was put to market without adequate, adequate clinical trials by a company that prioritized commercial gain. Where have we heard that before? It was rolled out of scale at a scale by health service that didn't track complications, and the people who suffered were largely women, whose pain was, as has happened so many times throughout medical history, dismissed as psychological rather than physical. So there has been a pause on the meshes use for stress urinary continent incontinence since 2018 so not that very long ago, and it's not been lifted, the picture above across devolved nations varies slightly, so Scotland, Wales. Yeah, so globally this story continues. It's still used in some countries, still contested in others. Some women did benefit from it. That's important to acknowledge. It is, but there are no numbers on that. And for 1000s who didn't, we're living with permanent irreversible damage, the question of accountability still pretty much remains largely unanswered, and the companies, the regulators, clinicians who dismiss these women for years because there wasn't enough evidence. Very few of them have faced any real consequences at
all. I don't really know what to say.
You're shocked. Yeah,
I am a little bit, yeah,
yeah,
I'm also a little bit shocked that in 2026 there isn't actually a solution to that problem.
No, there probably wasn't the clinical trials might have found an alternative, that's the thing.
Yes,
yeah,
I feel like that's something that
the clinical trials would definitely have you know have picked something like that up, and clinical trials are over a period of a longer period of time, they're not, you know, as things have changed, not in this case. I just want to leave you with something I think captures injustice pretty much perfectly. There's a one woman, woman I'm not in the name of, speaking about the scandal, said she simply wanted someone to say I'm sorry this happened to you, and I really mean it. That's pretty much all she wanted. She's still waiting, and 1000s of them are.
I think she's more likely to get money than she is to get that. Yeah, be honest,
yeah. Because actually, an apology is pretty much seen as admission. Yeah, yeah. So, so where does it leave us? Well, slowly, imperfectly, and far too late, the door is beginning to open. Product liability payouts in 2024 against the manufacturers shows progress. Campaigners like Cass Sansom of Sling the Mesh, who's fought the battle for nearly a decade - we're in fact, it's over a decade now - called it Welcome, noting quite rightly that it is a fraction of, you know, the 140 women is a fraction of the 1000s. Researchers at Sheffield University are now working on safer materials.
Lovely.
Yep,
I still think anything man-made will have the ultimate.
Yeah,
that's
a good point. The next generation of women needing treatment will have better options, hopefully.
Yeah,
the patient safety commissioners recommended a proper government redress scheme, so it's slow, but like with like a lot of these things, and included is that it's things like the contaminated blood scandal and the hip replacement scandal, that those they take persistent, persistent protest?
Yes,
and dogged determination.
You complaining to GP, this is real escalation.
Yeah, if there's a few people that can be ignored, but once this starts to go as a groundswell,
yeah,
yeah. So it's, it's not over by quite a long way, but if we just kind of come back to Cumberland, review court victories, the research, the redress, the recommendations, these all happen because the women victims in this circumstance refused to be quiet, those who were told that their pain was a matter. And read the organized campaigned and made themselves impossible to ignore, which is when you think about it quite, quite magnificent.
Well, dealing with all of that. Yeah,
yeah, I don't think we've earned a brew after that.
Can you find a little lie down?
Yeah.
Thank you.
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