Women not included: Medical devices

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1:03Dr Ella Hubber:I did a week-long first aid training course a few years ago, and we had to do CPR training on a mannequin. So these life-sized training dummies whose chest compress when you push on them. And of the dozen or so CPR mannequins in the room that day, they were all models of male bodies, or at the very least, they were genderless. But what was clear is that they lacked breasts, which is a key part of most women's anatomy. I think this might not seem significant at first, but research has shown that women are much less likely to receive CPR after cardiac arrest because bystanders are, quote, worried about touching their breasts or to be perceived as assaulting them.

1:51Dr Ella Hubber:and this is partly due to not being trained on something which realistically represents women. This is a real problem. Every minute someone undergoing cardiac arrest goes without CPR decreases their chance of survival by 10%. I'm Ella Hubber and this is Women Not Included for Discovery on the BBC World Service.

2:16Dr Ella Hubber:In this six-part series, we will be exploring the many ways the world has not been designed with women in mind. Today, we're talking about life-changing and life-saving tools, medical equipment and devices. And joining me to dig into this is health and science journalist Candice Bailey in Johannesburg, South Africa. Hello, Candice. Hey, Ella. Candice, have you done CPR training before? I have done CPR training, but this was in my final year of primary school. So, I mean, I was 13 at the time. So I guess you weren't necessarily thinking about if the mannequins had breasts or not. I wasn't exactly.

2:55But putting my personal experiences aside, I do know that there's a belief that chest compressions must be performed differently on men and women because of our booming chests. And this is completely absolutely not true. So I looked into it and I learned that there is actually a solution. It's called the womannequin. Womannequin? Exactly. Rolls off the tongue. Rolls of the tongue, not actually, but it's quite a novel concept. It's a silicone vest that was best designed to slip over the standard flat-chested CPR training mannequin. How cool is that? It was designed by a New York-based ad agency called Joan Creative.

3:32The idea was that a vest could be put over the mannequin to help the CPR trainees become more comfortable with giving women CPR.

3:39Dr Ella Hubber:I have seen quite a few CPR mannequins over several first aid courses now, and I've never seen anything like this implemented. So it's clearly not mainstream yet. No, you're absolutely right. It's not mainstream. Isn't it just so shocking that while CPR mannequins have been around for 60 years, six decades, the first mannequin was only created six years ago. But you know, the big question that this all raises for me, Ella, is if we've overlooked something as obvious as breasts and CPR training, What else have we overlooked when designing medical equipment? Well, that's exactly what we're here for, Candice.

4:15Dr Ella Hubber:But I think first we need to do a bit more thinking, a bit more research. So I'm going to go and find some experts to talk to about this and we can reconvene soon. Does that sound good? Sounds like a great idea. See you soon. Erosion and movement into other organs, chronic pain, infection as well. She has to stop and ask her second operator, who's often male, to swap with her to do this task. So we hope that we can understand what matters so that we can make better devices and better options for women. Yes, we do need someone to redesign these devices. They are not comfortable. Hi, Candice. Welcome back.

4:56Dr Ella Hubber:Hey, Ella. Where do you want to start? So I want to start with implantable medical devices. These are devices that are placed or surgically inserted into the body to do things like support organs and tissues, deliver medicine, or monitor your body's activity. So these are things that we would have hoped would have been rigorously tested before many people were having them placed in their bodies, right? Yes, you would hope so. But I'm sure, as you've anticipated from this series, that it's not always the case. And I talked to Laura Wells, who is an assistant professor in the Department of Chemical Engineering at Queen's University, and she works on making materials for medical devices.

5:37Dr Ella Hubber:She has researched and written about how various medical devices do not work as well for women or even put them at risk. So these include hip implants, cardiovascular devices like implantable defibrillators, and one that Laura is particularly concerned about, surgical mesh. Surgical mesh is usually a plastic. It's woven into a netting and that makes it very strong and that makes it very flexible. So it can be used as a device to support organs. It's used in pelvic organ prolapse as well as urinary incontinence. If we look at pelvic organ prolapse, it affects up to 50 % of women. Actually, worldwide in 2019, it was estimated that about 13 million new cases were coming out that year alone.

6:27So for pelvic organ prolapse, it can be implanted either trans-abdominally, it can also be implanted transvaginally.

6:35Dr Ella Hubber:So just to clarify, pelvic organ prolapse occurs when pelvic floor muscles and ligaments weaken, causing organs like the bladder or the uterus to bulge into the vagina. And things like childbirth, ageing and menopause can cause this. And so you're saying that the surgical mesh used to treat this is problematic or has been problematic for women? What kind of outcomes have we seen? When it works well, it works very well. The challenge is in about 10 to 15 % of cases, there are issues. And these issues can be erosion and movement into other organs. It can be chronic pain. It can be infection as well.

7:13The issue is how to remove those devices afterwards. Many consider it to be permanent. It integrates between those organs. And so it's very, very difficult to remove.

7:24Dr Ella Hubber:Before women have been given these, have they been warned about these potential side effects? In the early 2010s, reports of negative outcomes were starting to be considered. And so in 2012, there were some warnings put in place. By 2019, the obstetrics and gynecological panel indicated that manufacturers had not demonstrated a reasonable assurance of safety. And so for pelvic organ prolapse, it was sold in the US in 2019 and same with Canada. But it varies across the world in what indications transvaginal mesh can be used for and not used for. I guess what surprises me is that given these risks, how it was ever used on women for this purpose in the first place.

8:08The best way to look at this is the history of regulation of medical devices. In the 70s, many countries across the world started regulating them. Before regulations came into place, if a device was already on the marketplace, it was grandfathered in without clinical testing. There's been 60 plus mesh applications that have built off of that initial approval and didn't require the stringent clinical data that we expected to exist. transvaginal mesh was based off of hernia mesh. And so even though it's being implanted through a very different environment through the vagina, there was no additional clinical studies that were required.

8:49The other part was at the time tracking long-term medical device outcomes wasn't done.

8:55Dr Ella Hubber:Just to get a bigger picture as well, another area you mentioned was hip implants. I know these are used in both men and women. Where are they going wrong for women in particular? There's multiple parts to a hip implant. There's a pelvic socket, and then there is a femoral head, which is usually a ball, and then there's a femoral step. So they work together. Metal and metal implants are made of both metal, the thought being that they would last longer. But there were some challenges, and a lot of it became prevalent with women because of their different shapes and sizes. And what can happen is there's wearing, and they release little metal particles.

9:32and the immune system responded to those particles. And how our body responds to the medical device likely is different between the males and females, right? And this is an area that's growing. It's an area where people are finally recognizing that there are these differences. And some of those differences are because of our genes, right? The other factor is there's hormones. And so there were some very large lawsuits, a lot of big issues. the metal on metal implants have been removed from the market, although some people still have them, right? But it goes to show that had females been included, those issues probably would have come to light sooner rather than later, which would have benefited everybody.

10:15Dr Ella Hubber:Thank you to Laura Wells. So basically, Candice, the materials that medical devices are made from are just not always suitable for women's bodies. And I'm astounded by how severe this can be. surgical meshes that erode and move into other organs, hip replacements that are literally breaking inside of women. The issue of hip replacements really hits home for me. A couple of years ago, my mum actually underwent a hip replacement. So thankfully, she doesn't have the metal on metal implant because it wasn't very widely used in South Africa. But just to know that she might have had this and that there are other women out there who still have this is actually really concerning.

10:57Dr Ella Hubber:What's concerning to me is that many of the women who have these might not even necessarily know that they have this kind, and they certainly won't know the risks associated with them. Exactly, because it wasn't even explained to them, I bet. It wasn't even considered a risk. Yeah. So I did look into hip plants myself, and I came across something called hip resurfacing. Basically, it's an alternative to a total hip replacement where instead of removing the entire ball of the joint, the surgeon just reshapes the top of the thigh bone and puts on a metal cap at the top to fit into a new metal cap in the pelvis.

11:28Dr Ella Hubber:Let me just try and picture that in my head. So yeah, your hip is like, it's a ball and socket joint. Exactly. So if you can imagine like you're fitting your hand, one hand over a fist of your other hand. And so you just kind of take the top off the ball at the top of the thigh bone, you put a little bit of metal on and you pop it into a hip, which has a new kind of joint there. Exactly that. Exactly that. So this is often considered a really attractive option for younger active patients because it really preserves the natural bone a lot more. and it can mean better mobility and you can have a more active lifestyle afterwards.

12:01Dr Ella Hubber:That's nice, but it is still like a metal on metal implant. So surely women are going to see the same issues that Laura told us about. Well, those metal on metal complications would actually have applied here. But rather than redesigning the technology, the solution for years was simply not offered to women, of course. You know, I don't like it, but in a way it is better than just putting implants into women and assuming the male data will apply to them. Yeah, I get your point. I completely do get your point. You know, that was one of the shocking things to me from this interview, that medical devices can be grandfathered in when new regulations come along and then used in a completely entirely new part of a woman's body without further testing.

12:43You're damned if you do and you're damned if you don't, quite frankly.

12:46Dr Ella Hubber:I was actually shocked to hear this, but thankfully, this does seem to be changing. So in the UK and the EU's latest medical device regulations, legacy devices that were previously approved under old regulations must meet the new stricter requirements now. And the funny thing is, this isn't just a women's issue. Regulation like this will help everyone.

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14:18Dr Ella Hubber:You're listening to Women Not Included for Discovery on the BBC World Service, where we explore the many ways the world is not designed for women. We've already discussed CPR mannequins without breasts, leaving women less likely to receive life-saving treatment and implantable medical devices deteriorating inside women's bodies following a lack of testing. Women not being represented in the data for medical equipment is an issue we see again and again. But it doesn't just apply to patients. I want to turn now to the surgeons who may implant those devices. The tools surgeons use are considered medical devices.

14:53Dr Ella Hubber:They go into a person's body. And Dr. Gráinne-Torrel, who carried out research into surgical tools at the School of Architecture and Product Design at the University of Limerick, says that they are not fit for female surgeons. In fact, much of the operating theatre isn't. You can start off by looking at the room in general. Like the operating bench would often be set to the tallest person in the room's height, so usually a man. And then we can look at a lot of the really traditional surgical tools like forceps, scissors. They're sized for men's hands. And because they're so integrated globally into so many different procedures that like changing a scissors size is going to have a big impact on manufacturing them everywhere.

15:40Dr Ella Hubber:So that's kind of why they stayed that size. But your work specifically focuses on newer catheter based tools, right? So tools which insert a flexible tube which can deliver medicine or even like small medical devices. Right. So I kind of specialize on cardiovascular catheter-based tools, but, you know, there's obviously inherent comparisons across different disciplines that use catheter-based tools. I'm going to give the example of aortic valve implantations. When someone's aortic valve is diseased, it's not closing properly. So it's allowing a backflow of blood. The goal is to implant a new synthetic valve.

16:18Dr Ella Hubber:So this valve is crimped down within the catheter. The catheter then feeds it all the way through the body. And then while the surgeon is operating on the handle at the faraway end, that can cause then reactions then to release the valve within the heart. So you have a kind of catheter, a guide wire and a handle that's operating the tool at the end of the wire. Yeah, there can be multiple guide wires as well. It's very complex. Okay, there's a lot going on here and it's a very delicate operation. How do the physical differences between the male surgeon and female surgeons come into play when using this kind of tool?

16:58Dr Ella Hubber:We're looking at things like hand size, grip strength capability and height. So the handles, if those are too large, that significantly lowers the amount of grip strength someone can apply to it. So if a woman has a smaller hand she's not getting as much surface area onto that handle to get a proper grip around then it can really increase the amount of force and energy she's exerting to just push it through the body. There's kind of anecdotal evidence of well if you can't do this task because the grip strength is too high and you're having to use two hands if you can't do this with one hand you're not going to keep up with your male peers.

17:37Dr Ella Hubber:I had an interventional surgeon tell me for a certain tasks, she has to, even if she's the primary operator, so, you know, she's in charge of the entire thing, she has to stop and ask her second operator, who's often male, to swap with her to do this task. That's probably a little, maybe, embarrassing for her, I'm not sure. And then for certain procedures, when we're going in to access the artery, the standard is to go in at a 45 degree angle. You can imagine if the table is set quite high and someone is shorter, their elbow is going to be deviating quite high up. Like I have seen a woman's elbow up above her head to get that angle in.

18:15Dr Ella Hubber:That again can have implications for pain, strain, maybe missing out on work due to that. So there are long-term injury health effects to this. Yeah, exactly. And for surgeons, they're often doing long hours, repetitive hours. And there's that aspect of they're in charge of someone's wellbeing. There's the pressure of this job has to be done properly and you can't say, oh, I need a break now because my shoulder's sore. I mean, that brings in another aspect of this. When the tools aren't designed properly for the surgeon, does that increase risk for the patient too? For sure. If the handle isn't suitably fit to the surgeon's hand size, there's a risk of then slippage or something like this, which can risk maybe puncture.

19:02Dr Ella Hubber:And at the start, you mentioned, you know, scissors, tables, older, well-established tools that are very difficult to change because they are ubiquitous. But, you know, the equipment you're talking about, they are reasonably new. They are still being updated. Why are these not suited to female surgeons? It takes a lot of resources to gather data which will inform the design of these devices. So we call it anthropometric data, measurements of the body. The large data sets that we have access to, a lot of those are military data sets. So the US army have run multiple studies where they're trying to size up their military in terms of what size protective clothing do they need.

19:48Dr Ella Hubber:So those are really useful data sets, but they have inherent bias because it often ends up being a predominantly male data set. There's a very large study on hand grip strength done in 2016 and men in Europe. They had a 50 kilogram grip strength, but then women in Southeast Asia have a 22 kilogram grip strength. So we need to be considering a more global user group. So Gráinne told me that surgical tools and even entire operating environments have been built around a male body, a male average. And that mismatch is putting a lot of strain on women surgeons. And that can be their health, it can be their career progression, and astoundingly, even patient safety.

20:35Imagine having to say, okay, I'm going to get to this part now, please, can you come and do this part for me because I can't do it because I'm a female.

20:42Dr Ella Hubber:It's just, it's very demoralising. Yeah. You know, surgery is an incredibly competitive field. One study I saw in the British Medical journal found that over half of female surgeons had faced discrimination. It also found that women were less likely to receive formal mentorship and that there was a lack of flexibility in work hours, which becomes harder for women with childcare needs that often fall on them. In the grand scheme of things, poorly designed tools are, you know, a drop in the bucket, but it's just like such an unnecessary barrier in an already difficult field. I mean, the other thing that I found really interesting from the interview was the army data, the fact that actually in the army, it's all male-dominated data.

21:27So it comes back to this concept of actually even the data that's officially being collected is not really considering women at all.

21:34Dr Ella Hubber:I find it wild that the data we're collecting for medical devices is coming from the US military. Like that is fascinating. Imagine. Slightly off topic, Ella, but I mean, recently I bought a pair of pruning shears. And although they didn't have specific pruning shears for women and men, I was actually pleasantly surprised to see that they did have a pruning shear for a larger hand size and a pruning shear for the smaller hand size, which I thought at the time was quite pretty considerate. I mean, as we heard from Grownia, this might not be enough for all tools if there is a height difference to consider or a grip strength difference to consider.

22:14Dr Ella Hubber:Although I feel like you'll probably be fine with just a different size pruning shit. Yeah, they've worked for me so far. I'm okay for now. Good, good. And I'm glad that you bring up that you've seen an example of a tool being catered to a more diverse audience, because that's an important part of what we want to do on this programme. Yes, there are problems in the design of medical equipment, but there are also people who want to change that and are taking action. So Gráinne Terrell is one of them. She wants to improve the tools for female surgeons, although the first step for this was just finding data that actually represented women.