 Rwy'n cymhag siarad y gweld mewn fawr i'r lleif iawn i ddifeniwyr y fawr i'w ddefnyddio'r unwshbwyllt a chyfnod oedd gwnaeth amgarwmau hynny. Nid oes eu tîm wneud gwaen, rydyn ni ychydig yn gweithaf i fywyd i'r lleif iawn i ddim yn gyffredinol i'r lleif iawn i'r lleif iawn i ddim yn gweithio'r cysyllt ei bod yn lleif iawn i ddim yn gyma'r cyffredinol i ddim yn gwneud yn ei ddiddordebent PE1517, by Elaine Holmes and Olive McElroy, on behalf of the Scottish Mesh Survivors on mesh medical devices. Members have a note by the clerk and also with us today is Neil Finlay, who has an interest in this petition, and I welcome Mr Finlay to this meeting. Our first witnesses today are from the Medicine and Healthcare Products Regulatory Agency, MHRA. I welcome Dr Neil Maguire and Sally Mounter from the MHRA. Can I invite Dr Maguire to make a brief statement for around five minutes and then we'll move to questions. I'd like to thank the committee very much for this opportunity to come and speak to you today. The second thing that I must say is that everybody in the MHRA greatly sympathises and recognises the serious complications that women have had as a result of surgical procedures and the complications they've had of those surgical procedures. Just to briefly outline the role of the MHRA, our remit is to make sure that the medical device directives are followed by manufacturers, and that is done through notified bodies who look after the medical device directives in relation to manufacturers on our behalf. We are there to ensure that goods that are manufactured and brought to market have a CE mark, and that CE mark shows that those devices have complied with the relevant medical device directives that are in place at any given time. The directives are enshrined in European and UK law, and we have certain responsibilities within those directives as the competent authority. Most of our work is making sure that those directives are adhered to by the relevant parties. Once the device is on the market, we monitor it through adverse incident reporting, through reports from notified bodies, from manufacturers reporting, by engaging with professional bodies, listening to what patients say, engaging with regulators around the world and with other competent authorities. What I'm saying is that patient safety is a team sport. It's actually a mixture of regulation and all of the other people who are part of that process. One of the things that people don't always understand is that we have no influence over clinical decisions made between individual practitioners, surgeons, in this case, and their patients. What we do is work with organisations such as NICE, NHS England, NHS Scotland and other devolved Administrations to make sure that we are all working together for the purposes of patient safety. We'll now move to questions. Dr McGuire said that he manufactured and required to undertake post-market surveillance to ensure that their products are safe and fit for their intended purpose. Can you advise the committee how does the MHRA ensure that manufacturers undertake that effect of post-market scrutiny? That is done through the notified bodies and the notified bodies audit manufacturers to make sure that they are undertaking those processes. However, if you take one step back, before a manufacturer can get a CE mark, they must provide evidence, as is required by the medical device directives, of their post-market surveillance plan. We at any time, either through the notified bodies or directly, can make those inquiries of manufacturers. It's part of the process that we continue to look at those feedback mechanisms to us. In your introduction, you said that notified bodies are a kind of team sport. Whilst the MHRA has responsibility for the notified bodies in the UK, I noticed that the manufacturer, for example, can go to another notified body somewhere else in Europe. How, then, can you give the committee and others what kind of assurance that, whenever an incident is brought to the co-faces, how, then, can you give us what kind of assurance that is fully investigated? We work with all the other competent authorities across Europe and, indeed, with regulators worldwide. However, if we are just talking about Europe, we actually have a monthly vigilance teleconference with all of the competent authorities. For example, with mesh and tapes, they are a standing item on that agenda. In terms of other devices, we work together as competent authorities. We undertake joint inspections of notified bodies across the European Union as part of the European Commission's drive to harmonise standards. We take part in their audits of notified bodies in their countries and they also take part in audits in the UK. We found that that collaborative inspection auditing has strengthened the whole process, because we are aware that there were potential weaknesses in that system. You mentioned Dr Maguire that a notified body in the UK works under the same strict criteria as that of its EU counterparts. In Scotland, all adverse incidents should first be sent to healthcare facilities Scotland. What relationship does the MHRA have with the health facility Scotland in investigating such reports? We have a very good working relationship and we regularly have contact so that any reports that come to us go into our reporting systems and are investigated as necessary. Part of the process is that we do not just investigate, but we also look at trends in reporting, because there may be a situation, for example, where somebody reports something in one particular location and to them that is an individual report and that is not a very strong signal to them. However, if 10 different people in a similar location report the same kind of incident, then we can see that there is a trend and that something is out of the ordinary, and then we would investigate further, because we have daily meetings, weekly meetings, meetings, looking at instant reports, trending and then we also have a higher level supervision of the trending that comes in and it is looked at from, I do not know if you know the type of people that work within the MHRA, but there are scientists, engineers, doctors, researchers, statisticians and each of those groups brings something different to the equation, but the common group in all of these interactions is the clinical team, because certain aspects of devices are purely engineering and biochemistry or whatever, but the key to all of this is, as I said at the beginning, is patient safety, and you have to interpret that information with a clinical perspective. Now, within the MHRA we have some expertise, we do not have all the expertise, it is not possible to do that, but what we have is access to healthcare professionals who have expertise in all of the clinical areas where we require extra advice, and the clinical team takes all that information in and then looks at that and says, right, this is the balance here, because when we're investigating and we're taking action we have to be proportionate and we have to work on the scientific evidence and the best evidence that's available, because if we, say for example, if we applied regulation to the strictest criteria there would be no innovation, there would be no products coming into the market and patients would not get early benefit from new devices and new technology, because technology is just turning over so fast, there are 500,000 medical devices out there that we regulate and the highest risk devices are something like 90 plus thousand devices, and so that's why the systems we have in place are about surveillance, about working together with all of the groups to make sure if, say, example you put the product on the market and you've been watching the trend of how it's performing and suddenly you get a whole flurry of reports in, that might be due to a fault in manufacturing, there may be a bad batch of something going through the system and we can pick that up and then we can go and investigate that and we've had examples in the not too recent past where we saw an incident like this, there was suddenly a whole group of failures of devices coming into the agency from different sources and we went to investigate, we went back to the manufacturer and said what has changed and what they'd done is they changed their manufacturing facility from one country to another and they now had a workforce that was not as highly trained as the previous workforce and the manufacturing tolerance has changed so we picked up those changes and we went back to them and we said this is not good enough, this needs to be fixed within a period of time, we agreed it because it was all about the manufacturing process and between the manufacturer of the notified body and the MHRA the manufacturing was brought back into proper tolerances and the amount of incidents as the old stock was diminished because it wasn't practical to remove all the stock, we warned clinicians that there was a potential problem and if they experienced the problem then report to us and stop using that batch for example to make sure that there was a constancy of supply as well as making sure that the corrective actions were taken so it's always a balancing act so that's where the proportionality comes in you can't just suddenly pull a whole load of things off the market if there's a small problem because if you do that there may be nothing to use so again this is this is a highly complex area there is there are so many interacting factors which we have to make judgments on which is why we engage with the widest possible community to make this a reality. I know the MHRA's report relies heavily on the York University Health Economics Consortium report from 2012 and they reported that there was significant variance in the complications as a result of mesh implants and it's unclear as to the rates of adverse incidents in Scotland or the rest of the UK. What's the continued basis for MHRA continuing to promote the benefits of this device against the risks? One of the things that again is is not well understood is that regulation in its in its present form and probably will be into the future is about judging risk. When you look at benefit that's where the shift occurs into the clinical community so what we have to balance is is the device in itself inherently safe because it complies with all the regulations and then when it's used is it being used in in accordance with the manufacturer's instructions is it being used in the way it was intended to be used and then there is a spectrum of the device at one end of that spectrum and at the other end it's clinical practice and application of that device in a clinical scenario. Now as I said earlier on we don't have any influence over what the clinician does on a day-to-day basis that's a judgment for the clinician in conjunction with informed consent with the patient now that doesn't mean I'm we's the wording to say that we're not involved in this process because we are and that's why we're so heavily involved in the Scottish independent review which is moving forward as we speak and with the NHS England working group which is achieving the same and we understand that there is the device perspective and then there are clinical perspectives but that question involves the information which has been reviewed by NICE which have produced quite clear guidance on a number of occasions about the use of these devices plus backed up by Sir Bruce Keogh's letters of 2012 and 2013 which reinforce that clinicians should use the devices in the appropriate way with the appropriate training and audit their practice under particular measures which are in their guidance because complication rates have been difficult to interpret previously but if you look at the fact that there have been over three and a half million devices sold across the world 170,000 in the UK and something like 130,000 operations in England that is I don't have the figures for operations carried out in Scotland. We are not seeing the level of complications that you would expect from the information that we've been given by various patient groups who tell us that there are hundreds and thousands of women who have serious complications when the evidence from the literature from those studies done by NICE completely independent of the MHRA from the reporting we're getting puts those serious complications into the same ballpark. We don't have that evidence at all and that evidence is not available across the whole world and there are no competent authorities there are no regulators across the world who have actually taken steps to withdraw these products. Now what I'm aware of is that there have been two small Australian companies that have been pulled from the TGA's register but to us without having had the opportunity to speak to them because it only happened a couple of weeks ago it looks like it was technical issues with their documentation and it is there's nothing that says that it was done on the grounds of patient safety so there is no new information there and in fact we have just seen the TGA's report from 2013 which was just delivered to the NHS England working group which just goes through the same things but actually slightly behind in terms of timescales for our own production of evidence but doesn't actually make any recommendation or come to any firm conclusions about further action or direction and what we're wanting to see with the independent review in Scotland and the NHS England working group is that we're looking to the future because doesn't matter how small these serious complications are in terms of rates what we want to see and I'm talking as a working group member now is that when somebody does have a complication that it is recognised and there is a treatment pathway in place for it because we don't want to be seeing all these adverse incident reports becoming more and more and more what we want to see is that when there is something that is a complication of a surgical procedure that somebody takes it seriously and does something about it so that I hope that somewhat answers that question. Thank you for the response and I'm sure other members will have questions arising from that response because you've certainly raised a number of issues in my mind. It's a point of information that might be of assistance to Mr Walston, is that in relation to the point that's just been made? Thank you, convener. It's really just as I said that there are a number of issues that have been raised in that response but could you tell me whether MHRA has any views on the issues between mesh implants for SUIs and pop procedures? Is there any views on that or do you have any views at all on how these devices are being used in procedures because you seem to continue to refer to the clinical use of the device rather than the device itself? Yes, the device and the devices have been through the relevant procedures to satisfy the regulations in all countries and as a regulator we have overseen that process and once that process is complete they have been given a CE mark or in the United States the appropriate approvals for use and you could in the strictest sense of interpretation say that we could step back and then not be involved any further but that's not how we see our place in this situation because when we see that there are signals where there are complications and issues we want to be part of the process to make sure that we are getting as much information as we can and the people are feeding back to us as best they can and we can then all move forward and act together but what I said before about the signals that are coming from all different sources are giving us virtually the same complication rates now it is definitely the case that complication rates for stress urinary incontinence surgery are lower than for pelvic organ prolapse but what has to go into the mix here is that pelvic organ prolapse is a very complex illness of itself and it has a natural history of deterioration if not treated and even with treatment and this is from my understanding from from clinicians because I'm not an obstetrician a gynaecologist and the reality is this is a question for them but what we're seeing in terms of complication rates is that for certain aspects of the procedure the complication rates are not particularly high but when it comes to sexual function that that is up into the 15 per cent range but to put that into balance up to 70 percent of patients who have pelvic organ prolapse and urinary incontinence have problems with sexual function before they have surgery and this is from the published literature and following surgery that improves excuse me excuse me John listen I'm sure everybody agrees that there's a great interest in us right but we really need to be following parliamentary code here and you know what we'd ask the you know the people in the public gallery that we really need to hear the answer to the questions we may not agree with that but we really need to hear the answer miss mingle I always like to continue what I was saying was that if we had a higher level of reporting which showed that there were more complications than than we're seeing then we are always prepared to change our view so if we had thousands upon thousands of reports to say that this was an issue that that wasn't with the complication rates that were deemed acceptable by the clinical community then we would change our stance but we can't act without information and that information does not appear to be out there there is the other thing to balance in in this situation is there are thousands and thousands of women who have had these procedures who have benefited greatly and stress during incontinence and pelvic organ prolapse are distressing and unpleasant conditions which women seek treatment for and that's aside from saying there are something like and this is from NHS England figures about six million people in the UK who have got some form of urinary incontinence incontinence now not all of those seek help because that would completely overwhelm the health service but that's just to put these kind of things into into context so that we don't go down the line of disadvantaged people who are going to be helped and have been helped in large numbers from having these sorts of procedures and that's where the proportionality again comes in in our considerations in our actions and this is why we've engaged so heavily with the clinical community the Royal College of Obstetricians and Gynaecologists British Association of Urological Surgeons and the British Society for Urinary Gynaecologists are all in agreement and you will all have seen their letters expressing surprise at the stance that was taken in Scotland regarding the request to suspend these surgical procedures and we are working with those people and with NICE and with patient groups to find a way forward to address the serious concerns that those affected by the series complications have but we are not in a position with the information we have to take any further action now the other criticism that has been made of us is that we haven't issued alerts we haven't put out an mda or made the manufacturers put out a field safety notice but actually that was considered in 2012 and the decision was made was because this was so much in the clinical domain that it was better to come from Sir Bruce Keogh and Professor Keith Willard and then later reinforced again by Sir Bruce Keogh so well that's why we haven't put out alerts and people have said why haven't we done it now because of the things the FDA have done we actually work a different regulatory system to the FDA and the information they put out is different that one of the last statements was that the complications were not rare now we don't know what that means we don't know what not rare means and we can't we can't base regulation on that kind of statement at least we're working to the numbers that are coming in from all different places not just from one single source not just from adverse incidents but from the clinical community from scientific papers some of which are randomized controlled trials and if you want to see that information i don't have it in my fingertips but that is is all the information that's looked at by NICE before they produce their guidelines john thank you convener and follow up question to that is at what point would mhra recommend that these devices be either classified as high risk or be removed from the market because you've made reference to studies and reports and clinical reports but at what point would be the decision or the reporting mechanism that would give mhra the confidence to either classify these devices as high risk or recommend that they be removed from the market these devices are already in the medium to high risk category so there is there is no benefit to reclassifying them in in in the uk or in europe and we discussed this with our european partners they're already subject to the appropriate scrutiny for that type of device in the united states is different their classification system is different to ours and you you can't match them up and in fact the united states said they are considering reclassifying but they haven't done anything about it at this point they haven't changed their stance and we we've been involved in working with them and we've been to their their their public meetings where these sorts of things are discussed and there is no change to their stance on their website at this time they have made no moves to withdraw ban or or otherwise restrict these devices and if they do that then they will be talking to us first as we do with all other devices that where we we cross over because a lot of devices are obviously made in the united states others are manufactured here but some of the notified bodies for c marking in europe are in this country so we have we have regulatory powers um in in perspective then um in terms of what when would we act well it this sounds a bit of a feeble answer but the reality is it depends on the device it depends on the seriousness of the complications it depends on the reporting rate and whether the complication rate is outside that which is reasonably expected for that type of procedure given current knowledge so if the manufacturer and the clinical community had decided that a complication rate of say i don't for no no other reason it's a number of five percent and we've done this with other devices so if all of a sudden the complication rate is four point five five percent five point one percent then we start thinking we've exceeded what is reasonably expected in this circumstance given all of the other information about that particular procedure about the risk associated with it about the complication rates of other things plus added into the mix of is there something or other other device or the product which could reasonably substituted which has got a lower complication rate then that would be taken into account as well because as i said before if you suddenly withdraw something and there are still considerable numbers of people benefiting from a particular procedure or a particular use of a particular device they have to be considered as well and that balance will finally come down to the individual discussion between the clinician and the patient and it is up to them to make those judgments provided of course and i can say this is a clinician that the process of informed consent has been undertaken in an appropriate and clear way and one of the things is that some people when they have the risk explained to them will still have a procedure because their life is being affected so badly by the symptoms that they currently have and they will take that chance and you could say it's analogous to the first people who had hip replacements if you went through that process now and analysed the results of the first hip replacements and said no no no it's far too risky with the components are wearing out nobody would have hip replacements now but what we know is the technology improves consistently over time but yet we still know that if you have a hip replacement at a younger age within 10 to 15 years you may well be looking at a revision anyway because of the natural history of all types of hip replacement because you can test something to destruction in a laboratory in an engineering plant but when it comes to implanting it into a biological organism then some of those dynamics change in a way that cannot be predicted and that's where post-market surveillance and where vigilance is important in identifying those things so the natural history explanation I appreciate that but you know we do have a number of questions yes sorry sorry that you ask so Angus you have a supplementary to that yes thanks convener yeah just to pick up on on a point Dr Mcquire Mcquire just mentioned and just for clarification on a level of complications are you saying that there's no mesh device out there that has a complication rate of over 4.5 or 5 percent no that's not what I'm saying okay right which is to clarify there are if you look at the scientific papers depending on the research papers and and the things that are published there are ranges of complications always and those complication rates are a mixture of when the device was introduced the experience of the surgeon the surgical team the developments of the device so over time and when you first introduce any surgical procedure it doesn't have to involve the device then there is an increased rate in complications and that is well recognised across all all medical practice and then over time the learning curve flattens out and then the training programmes would in place there are various guidances issued because then so going back just one step when you start doing a procedure you have in your mind and the manufacturers have in mind if a device is concerned what the potential complications could be what has been seen before in conjunction with those types of surgeries with those types of procedures with those types of devices etc so that's the complication list that goes into their their instructions for use and is is well known to the medical profession in training etc now there may be that there are complications that are completely unforeseen and those are the things that have to be picked up and things have to be adjusted so for example when meshes were first used it wasn't known that the number of anchorage points was significant so when you go over a certain number the complication rate associated with that particular design of mesh goes up but there was no way anybody could have predicted that but now that is known the meshes and the anchoring points are one of those things that are considered in the new designs of the the latest devices so again it's all about analogy here I don't know the way of describing it but when the first pacemakers were produced they were huge clunky things with batteries that needed changing far more frequently the leads that used to go into the heart used to break and that was the risk that went with that new technology now over time that has all improved and we all thankful that the manufacturers have put that effort that money that time and the experience of the surgeons doing those procedures all medical devices have a similar track record so devices that were made at the first instance were actually based on surgeons just using mesh that had been used for hernias and thought well let's try it in a different place but then bespoke meshes were produced and bespoke tapes for urinary incontinence were produced and there have been increasing improvements in those technologies over time and again it's the balance between offering people surgery and and medical technology which will improve their lives because they go to seek treatment because their lives are being upset by pain sexual dysfunction in this particular instance during incontinence and parts of their body coming out where they they're not supposed to be and that's highly distressing and very unpleasant thank you thank you for that mr McWire and Salah and thank you and good morning the mhra report also notes that there are a number of ongoing research projects which are likely to provide useful information in long-term safety and efficiency of the mesh implants what I would like to know is what is the scale of these projects and when are they likely to report back are you talking about the wire if you could be briefing your answer because we're about equations yes you're sure we know the prospects trial which has been sponsored by the department of health and that's due to report in 2016 I think so yes yes there's a nice report which has been produced which is looking into hospital episode statistics and they've had some preliminary work done on that but I don't know when that's due to complete but we can certainly find out for the committee and let you know there's the scientific committee on emerging and newly identified health risks which is looking at meshes generally that's supposed to report q1 this year and then of course is the independent Scottish independent review which is now due to report in early summer and the NHS england report which is or NHS england led report which is due sometime in the next 12 months but yes but it's been moved a little bit because and it's the same as the Scottish independent review being moved because they're realising the amount of information the complexity of it is is so great that if you're going to do it properly you might as well take the time to do it properly and we will be completely receptive to the findings of all of those reports and take them on board well it'd be extremely helpful if you could pass some of that information back to the committee yes of course okay Kenny thank you you've already obviously given an anecdotal description about issues related to the manufacturing process and referred to the tda report it didn't seem to differ between products but other factors such as skills and training selection of the patient procedure to what extent are adverse incidents in your view due to clinicians actions and how does this influence your assessment of the device right we as an agency want every adverse incident to be reported to us because to the person doing the reporting it is not always apparent which end of the spectrum that is so our judgments then are around has the device failed has the device got a problem that we weren't aware of but we would then go to our experts who were advising us and say is this a recognised complication of this type of surgery of this type of procedure what was the level of training of this individual so all of those things we pulled together so we would act as the honest broker in the middle of that situation to try and determine whether it was the device that was the problem it's in itself or whether there was an interaction between the device and the surgical procedure and in that particular circumstance or whether it was actually a purely clinical issue because until you until you view that spectrum you can't make a judgment but we're happy to get all the reports and we're actually working now even more closely with the NHS the national reporting and learning system so that all reports that go into NHS England and come from Scotland eventually because they're looking at being part of that as well I understand we will have a much broader base of reporting of incidents because in the NHS and I may be completely wrong on this number I think there's something like a million reports of adverse incidents come into the national reporting and learning system every year and they're able to search all of that data and we are now being given access to search it ourselves and make it into one database and make a single portal for reporting to make it easier for clinicians and and other folks to report and we've also streamlined the reporting to the MHRA directly so the yellow card now covers drugs and devices so that's all moving forward and we're looking there's also an initiative to produce a european database which will cover all of all of europe as well but of course that depends on the european parliament and those decisions evidence suggests that there may be an underreportant of adverse incidents can you tell me why there has been underreportant and what is the MHRA's view on the petitioner's call for mandatory reporting by all clinicians we know there's underreporting we know that healthcare professionals have not been as good as they could be and in our view should be and that's why we've had to consider evidence from all different areas but one of the things and we discussed this at the the Scottish independent review meeting yesterday and I was having a think about it we were actually talking slightly across purposes because when you say mandatory reporting to me as a regulator that is something that carries a regulatory sanction if you don't do it now that's not the same as a profession saying to its its members of its organisation or whatever it is that you should report this as part of good medical practice and if you don't do it then we will ask questions about you know how fit you are to practice and to do these procedures etc that's a different thing altogether because what we know from experience is that if you have a mandatory system which carries sanctions first of all which carries a sanction if you did it wrong in the first place and then carries a sanction which comes from the report then reporting goes right down because people don't report to what they're neck and a noose and some of the most tightly regulated systems for reporting have come from Eastern Europe and they're reporting in some of the lowest that there is anywhere so what we're working together towards is a collaborative system and that's part of the working group in England and the Scottish Independent Review is engaging with all parties to improve reporting and making sure that the positive incentive is that the culture is to report, the discussion of the problem that's been exposed by the reporting is open and free and not subject to sanction and that in doing that we're all serving patient safety much more strongly and the last bit in that is people who report have to have feedback if they don't get feedback there's no incentive to report again now that's a loop that we have never properly closed because it is such a big issue are covering so many different devices and that's not just a problem for mhra it's a problem for all regulators and and that is something that we're we're looking hard at but it will only be solved by everybody working together and as I said right at the very beginning this is a team sport and if we're not all working for the same thing and people don't understand why it's important to do these things they're just not going to do it so if we say mandatory from a regulatory perspective we don't think it will work if you say mandatory from the perspective and this this is going to sound a bit foolish mandatory voluntary reporting within a professional set of circumstances with incentives to do that we believe that that will produce results and it certainly has worked for orthopedic surgeons to the point where the national joint registry and mhra have been working so closely together we've got to a situation whereby they're working beyond compliance and by that reporting is is above that required for any regulations and the manufacturers have signed up to that and they're part of that process and we sit around the table together with the conditions with the manufacturers and we have results now on joint replacements that have been done over the last 10 10 20 years and what happens with that information is manufacturers then go out and say look we've got a 10 year tick our devices have got a survival rate up to 10 years and the incentive for them is to be part of this process so that they're being shown to be responsible in what they're doing. In the October report from the mhra it concludes with proposing the following actions improve reporting of incidents which you've just mentioned a structured post-market clinical follow-up registries on the use of unique device identifiers and patient reported outcome measures what progress has been made on taking these suggestions forward and what role would the mhra envisage for the Scottish Government in that process? All of those things are really important that's obviously what we put them in the report. We are very keen on the idea of registries the difficulty for us is that we can't have registries for all of the medical devices that we look after that will be completely impractical we'd have to have 10 times the number of people we have. The only thing we would say is whoever sets up a registry needs to engage with the people who want the information out of the registry because there have been registries set up in the past which have not provided the information that's required and it becomes useless so if you put the right things in at the beginning you get the right information out at the end so as a regulator we want the adverse incident reporting whereas the clinicians want the patient recorded outcome measures and that's what patients need so it's about having all of those things together and from the Scottish Government perspective and any increase or any acknowledgement of the resources that are required to produce those things would actually be really good because registries are expensive they require staff they require data input individuals and that's one of the impediments to good reporting and because reporting in the clinical setting lies around being able to do things such as multidisciplinary meetings morbidity mortality meetings and those things need to be resourced in terms of time in terms of people being able to get to them and do them and I'm only saying this not as a regulator but there's these these were things that were brought up at the meeting yesterday in Glasgow by the clinicians saying we we would like to increase our reporting we would like to be more compliant but give us more time give us give us in our job plan to be able to do these things and resource us to do it I think the average morbidity mortality meeting is an hour a week in in my clinical practice yeah but how much time do they need to get the wreck together with regard to reporting that's my point I think you have to ask the clinicians that yeah Jackson morning can I take you back to this york university report in November 2012 because we've quoted quite extensively from it this morning and also you have quoted from it and relied upon it in your November 2014 submission when in 2012 was the report commissioned I can't answer that question but it was around January February time 2012 okay what budget did it have or what was the cost of the report yeah I haven't got that to hand it was something like something like 40 000 pound I think 40 000 how many people at york university were involved in its production well not quite sure how many we were we were liaising with about three people but they may well have had team people teams of people behind them okay what call for evidence did york university issue in advance of their consideration of the issue we we had we had provided they put together a protocol and they were it was largely a literature review that's what it was it was a literature review a literature review yes it's similar sort of thing that nice have done um when they do literature searches I see but they look at they take evidence in a particular way so if you look at the procedures that nice go through to to get their information they start with the the highest evidence levels and then they work down to case reports but a 40 000 report commissioned by three people without any call for public evidence in November 2012 is regarded as being in the light of everything that has happened since a sufficient basis two years later and after the petition has been lodged here in May 2014 with what appears to be sufficient grounds for the cabinet secretary for health and well-being in Scotland to issue a call for a moratorium on these measures being installed that report from November 2012 appears to you in October 2014 to be sufficiently robust to allow you to continue to make the recommendation you are if you review the report that we've just produced it draws on more information and it does not and it does not just rely on the such as I mean I've got it here it used data from adverse instant reporting manufacturers sales figures patients although I understood you to say you thought that they were unreliable as an evidence base representatives clinicians manufacturers other regulators around the world are these all literature based surveys I mean what what further evidence was taken by mrha in its its consideration of its of its recommendation what was it just a bigger literature review no it wasn't just a bigger list review we looked at manufacturers own reporting we looked at and bear in mind that the manufacturers under the device regulations only have to report certain incidents that come under the heading of vigilance what we did is we went back to the manufacturers to look at all of the reports that they've received in these circumstances things that didn't even get to the level of vigilance and this is something that we we do with clinical investigations for example so we take we take all of the signals that we see and put them into the equation as well to see if they have an additive value or benefit we also engage directly with the clinical community who were doing surgery for problems with meshes we also discussed it with the senior people in those professional areas we also have soft signals which you see from engaging with people who are speaking at conferences who are looking at things that don't actually get it to be published but but posters and and say presentations and different people reviewing different aspects of their research and the literature but it's about accumulated experience with these devices so that's why we also engaged with authorities across the globe to see if they'd received any other information that would lead them to act in any different way and they did not do that so and we realised that the york report had limitations which is why we want those extensive efforts for the report that we produced for the chief medical officer for England but this is where i'm at a loss you said that various organisations and parties expressed surprise when the cabinet secretary for health and well being in scotland with all party support in this parliament called for a moratorium in june last year do you believe he was acting irresponsibly then in making that call i think that would probably be a question that i wouldn't answer because well i take that to mean yes no no i take that to mean yes health boards have some health boards have ignored the cabinet secretary's call for a moratorium and have used the mhra a report as the basis for ignoring the health secretary are you comfortable with that i'm comfortable with the fact that we have taken all of the robustly available evidence to us into account when we have come to our judgment but where is caution in all of this because not a 40 000 pound report but a 2 million pound report is one of those to which you have made reference that is going to be reporting back to us near hand is there not any on the basis of that is there not any need for a degree of caution to suggest that the cabinet secretary's call for a moratorium is a perfectly sensible call to make until this much much wider and contemporary and seemingly better researched and founded evidence is made available to us our discussions with the cabinet secretary and subsequent inquiries we made as to why he took the action he took we inquired if there was any evidence any further evidence which we had not been made aware of which led to that decision and we were told that there was none and on the basis of no further information and given the information available to us and across the world we were not in a position as a regulator to take action to do anything different than we were already doing all right i understand that i mean all you've made analogies at various points today i mean i suppose i could make an analogy of a contaminated food substance in a store then being withdrawn across every store in the united kingdom because the manufacturer doesn't think that the fact that only a handful of people might suffer from it is an acceptable basis for it then being available for sale elsewhere and i offer that analogy to you in contrast to your own but i understand and i respect and i appreciate the dispassionate way that you've given the evidence this morning i understand that has to be the case but my final question is this in the light of everything that is happening just now i would not recommend to a family member of my own that they have a mesh device implanted until the further evidence is available would you recommend to a family member of yours that they have a mesh implement implanted at this time let's remember the problem i mean i mean it's a serious question because these are human we know i know we've been sorry i wasn't answering no no you must ask the gallery i mean Jackson dr maguire minute please yeah listen sorry i'm very prepared to answer that question sorry let me let me finish now you can answer listen we really need to be aware of the the conduct within the parliament so as i say we may hear things that we like we may hear things that we don't like but please let's listen to what's to be said i'm only asking i mean it's a dispassionate evidence we've given but these are very emotional issues and so my final question i simply want to ask what you would recommend to your own family member i can really understand and i can answer as a husband as a clinician and as as a practising clinician what i would say to my wife if she had incapacitating problems within continents or pelvic organ prolapse i would say to her that you need to sit with your clinician who is going to do this procedure and decide what is best for you i'll come and sit with you i'm not going to say anything i will listen to what is being said on both sides if i want to ask a question of the clinician then that's what i would do but at the end of the day the judgment is is your quality of life affected to the point at which you would be prepared to accept the risks which are known with this particular procedure and if you did accept those risks i would want to be 100% assured that if you had a complication even if it was something that is not regularly reported like pain then that would be treated seriously by the whole of the multidisciplinary team from the general practitioner through to the incontinence nurse through to the physiotherapist through to the surgeon and there would be mechanisms in place within that particular health service to deal with those complications effectively and on top of that i would want to know that we'd been offered all the alternatives and that the non-surgical alternatives had been properly funded and had been gone through and there had been a point at which the situation without surgery was intolerable and those judgments should be made well let me conclude with this observation your experience and background has qualified you to understand everything you've just said that would need to be asked of the clinicians and others performing this potential surgery i can assure you i've heard from many constituents who had none of the benefit of that advice none of the benefit of that experience and who found themselves with a mesh implant with consequences that had not been drawn to their attention at any point in the process whatsoever thank you new yeah i think mr carlaw makes some very pertinent points there the point i was trying to get in earlier when mr wilson was speaking i apologize for interrupting but it was in relation to the australian situation where the australian register of therapeutic goods there as there are a number of items mesh items that have been cancelled and the reason for them being cancelled is because they don't adhere to the medical devices essential principles checklist that's the facts of the matter if you look at what they are saying on the website administrative not well it's safety if you look at the general principles it's about the use of medical devices not comprising complying with health and safety conformity of safety principles i could go on and on and on there's umpteen it is not a minor administrative error no no no i didn't say it was a minor administrative error what i said is that administrative process can be major or minor conformities with regulation can can but the tga says on its website when you look at those if there is a question of patient safety that comes under a separate heading that separate heading does not apply to any one of those products that have been removed from their register so that to me without going into it further and actually question them personally suggests there is not an issue of patient safety with these devices and that it is due to failure to comply with regulation you mentioned the words can and suggests therefore i think we might need to get to the bottom of that yes we'll be very happy we will speak to tga very soon and we'd be very happy to come back to the committee i was just then going to ask him what discussions have you had with tga about the withdrawal of these products and are any of these products being used in the uk they are not as far as we are aware because the the seven major manufacturers of these products are well known to us and before yesterday i personally had never heard of this this two manufacturers who are australian based and we're not even sure because we only found out yesterday from one of our researchers and then subsequently at the meeting in Glasgow that this had actually happened which to our mind means that these could they might not actually be manufacturers at all because under the regulations you become a manufacturer when you import from somewhere else so we don't even know where their products were being made so that's part of the inquiries we'll be making okay but we would have expected if tga were going to do a product withdrawal for patient safety reasons and we have no reason to believe they wouldn't have done this because they have with all other things the tga would have come to us directly before they took that action to let us know they were doing it in the same way the fda do that and other regulators across europe do the same thing so we're pretty confident that this is not patient safety related because of our observations so far but we will definitely be checking now we have that information given the problems that we have in scotland but under reporting and the problems you have in the uk do you know could you take a guess has anybody taken a guess as to how many problems that has been worldwide with these products we know from the literature and from our discussions with the other competent authorities and regulators that the complication rates we are seeing are mirrored across the world how does that reflect then the number of people who have submitted claims to courts because in scotland we have a very small number what's the number that you suggest in scotland the figures are for adverse incidents adverse incidents were reported to us since 2005 it's 88 for stress union consonants and that was up until February 15 for prolapse organ 37 so we could almost suggest that the entire number of those people are sitting behind you at the moment almost and one of the things i'm making my point which seems inconceivable we know that there are tens of thousands indeed probably hundreds of thousands of litigation cases sitting in courts in the us in Australia so therefore are these people making it up are they chanceing their arm to try and get a few quid out of something or do we think is it is it is there any assessment being made of whether these are legitimate cases of people having the same problems as the people who are in this room today we we've what what has given us the confidence to to carry carry on with the same stance that we've had is that despite all of these cases that and there have only been four or five actually that i understand in the states have actually happened of all of those cases there have been there have been different judgments and again it's not my area of expertise in any way shape or form but the judgments have been made not on the materials or on the design they've been about how the products have been used and the instructions the surgeon has had or conveyed to the patients so we need to understand more about that but actually those individual cases have not led to any regulatory action in the united states and you would think if the fda were being inundated with reports of adverse incidents and that all of those things appear on their more database and there are just not those numbers okay and we find it difficult to reconcile the fact that all of the evidential information we have from literature and from the reports we have even with underreporting do not reflect hundreds of thousands of patients with problems so given that assumption that you're making and given your comments earlier that when you spoke about pacemakers et cetera that the technology is you know crude at the beginning and advances with time what you're saying is that in your opinion it is not the product that's the problem that can only lead me to assume that you think it's the clinical practice that's the problem why is that is that the key is that your opinion that the product is not a problem because you're continuing to allow it to be used therefore the only thing that can be causing the problem is pure clinical practice i think we have to be careful when we talk about describing it to any particular group or any particular area we have to bear in mind that we're dealing with people who have a serious and complex problem in the first place they have ongoing other illnesses which have an influence they have we all we all get older and if we smoke and we're overweight that actually adds to the problems that the surgeon has and the procedural likelihood of complications so we have to put all of that into the mix so we can't just blanketly say so we wouldn't have an opinion that it is any one part of the entire process from selection to device being used to procedure to any part of that whole process has has potential okay so it's not the product you you're not prepared to say that then it's clinical practice well let me tell you my experience over the last two years i've met hundreds of women from across scotland and beyond they come from different towns and cities geographical locations they have different socioeconomic backgrounds different cultures they come from all over some of them have lost their organs some of them have to walk using crutches some of them use wheelchairs some of them have lost their jobs their marriages and all the rest of it they are very different women they come from all ages and all backgrounds the only thing they have in common is that they've been fitted with polypropylene mesh and have injuries now is that a coincidence do you think that is just a coincidence that that is happening they're not all overweight they don't all smoke now you know they don't have the characteristics that you some of them may have but i find it inconceivable that all of them from all of those backgrounds have one thing in common and yet the mhre are not prepared to turn around and look at them and say they are the evidence that there's a problem here we are aware that there are many patients who have had serious untoward complications following their surgery and their procedures the relative contribution of each of the elements related to those procedures has to be taken into account on the background of the complexity of the underlying condition now we can't make judgments on those small number of individuals who have had problems compared with the thousands of patients who have benefited from those procedures and have had an improvement in their quality of life as a result of it this this is a balance that has to be struck in all medicine as i said earlier on there is a balance between the risk of doing something and the risk of doing nothing versus the benefit of doing something or the benefit of doing nothing and that is a the final decision rests with the individual patient and the individual clinician as to what's the best thing to do in a particular circumstance and it involves informed consent patient selection picking the appropriate device following the guidelines that are out there and if you want to minimise risk we all have to work together to make that the case but we cannot get rid of risk it there is there is no medical procedure no drug that we take that is without risk but you can minimise risk now final final point one final one we've been full of analogies today and the analogy I use and this is is like a car if a car produced by a manufacturer had the drivers concerned that there may be a problem with say the brakes even if it's a small number who were reporting that there would be a recall or there would be a halt in production until that problem was resolved why is it that we appear to treat an inanimate piece of metal more compassionately more systematically than we do something that is affecting so badly the lives of so many people but that to be fair isn't what we're doing what we're doing is with no with a motor vehicle what we're not saying to the owner when you get in the car and you drive it there's going to be a risk involved because the brakes might not work or whatever it is actually drivers know when they get in the car there's going to be a risk because of the way they drive it this is the point here this is when a problem has been identified by a number of people so what what we don't have in in cars which as you say inanimate object is what is the complication rate for driving a car we have to accept that with any medical procedure there is a complication rate and what we have to make sure is if those complications happen which they invariably will do we have things in place that are in the health service and supported by the various agencies the practitioners etc to deal with those complications because they are inevitable they are going to happen there's not one thing in medicine that doesn't have a complication attached to it it is not a risk-free environment one final question from John Walsham just to follow up from Mr Finlay's questioning and I'll not use the analogy of the car but we'll use the issue about the reporting and the underreporting of the number of cases now as Mr Finlay said he's spoken to hundreds of women and we know by the campaign that's been established in Scotland that there are hundreds of women who have been affected by the mesh implant operation now how do you as mhra justify the failure to take action based on the number of cases that we're now hearing about because there is and you admitted earlier in your part of your response to an earlier question that there is a an under reporting because clinicians aren't reporting and you've actually said whether it becomes voluntary mandatory reporting or mandatory reporting is an issue that has to be taken forward but what is the criteria for taking action to stop the use of mesh implant operations in this device based on the responses we're getting as a parliament and this committee is getting from the women throughout Scotland and elsewhere that have had severe effects because of this the use of this device and the operations that are being carried out and have been carried out for a number of years and are still being carried out some of the points I made earlier on that we need if you are aware of hundreds and we are not seeing those reports then you need to use your influence and with our help then we can we can subsume those those numbers into the reporting now that's part of one of the the reasons for having the Scottish independent review and why we've been so keen to be part of it is because it is absolutely vital we reconcile this difference between the numbers that are bandied about by by various groups and I don't mean that flippantly what I mean is we get lots of numbers thrown at us but we can't work without evidence and there's no evidence in anywhere else in the world and we've talked to other competent authorities we've actually talked to the bladder and bowel foundation in in the UK and said are you seeing and hearing of reports of lots of women or men actually with with incontinence who've had procedures and having problems and they have said well no actually we haven't so what I can't understand is why we're not able to reconcile these differences because and we we've asked the groups to get everybody to report to us it doesn't matter if they don't have all the details if if we have verified that they're all different people because we don't want sort of vote rigging if you see what I mean but you know that we know these are all individuals reports then they go into the system and then we have that information and we've had four years requested that information and we have not received it and that has been the case in Scotland and that has been the case in England as well and we're at a loss to explain those differences and again when when Mr Finlay said that there were thousands and thousands of women in the United States who are awaiting litigation in fact one of the things that was said to us recently was we actually got a report from a patient we tried to investigate it and the patient turn and says I can't give you any more details because my lawyer has told me not to tell you anything now if the legal system is standing in the way of reporting as well that is a real problem to us and that occurred within the last few weeks McGuire can I thank you and Mr Mountain for giving evidence today to this petition I will now suspend until the video link is set up thank you can you hear me can you hear me hello can you hear me yes I hear you yes you've got it yes excellent superb well the picture is looking pretty good and if you can just give me a few words for just to let me hear the quality of the sound sure what would you uh can you hear me all right now that's actually what you've said up to this point is actually fine thank you very much excellent so I think we're ready to go our committee members are out and about at the moment uh they're not all fully they're not in the room so we'll get back to you in a second when they're all here sounds nice you didn't hear anything in the room oh that's interesting right okay mr slater can you just uh say a few a few sentences for me just need to get the public address in the room set good morning can you hear me okay is your test running okay I can it's certainly a little bit noisy in the room so I think we'll have to go with that I'm all adjusted as we do it for real that sounds fine whatever you need from me thank you that's pretty good actually that's looking and sounding actually okay yeah it's looking pretty good actually yeah but it's looking a bit peely wally but none the less it's okay I reconvening the meeting uh our second evidence session today is with mr adam m slater from maize slater cats and freeman l l c we're taking mr slater's evidence this morning via video conference from the united states and can I remind members that a delay will occur between members finishing their questions and the witnesses hearing and responding equally there will be a delay the other way for these reasons it's important that no one tries to speak over anyone else and members should speak only if called to do so and should not try to interrupt a colleague or or the witness as that will affect their ability to hear the answers can I welcome mr slater and thank him for making himself available at such an earlier to speak to us here in Edinburgh and I will start by introducing myself my name is uh John Pentland I'm the convener of the petitions committee and I will then go around the table and ask each of the other committee members to introduce themselves. John Wilson committee member good morning Angus MacDonald committee member Kenny McCaskill good morning Jackson Carlaw Neil Findlay not a committee member but interested party good morning thank you for having me I appreciate it can I invite you then mr slater to make a brief open statement for around two to three minutes and after that we will move to questions I will again like to thank all of you for inviting me to provide information to you regarding the pelvic mesh devices in 2007 I met my first client who had been injured by these polypropylene mesh devices and since 2007 I've been working almost exclusively on these mesh cases and meeting with many of the leading consultants and physicians in the United States regarding the injuries that women have been suffering and the the very serious complications that are caused by these products I've been spending great deal of time studying the literature and and again now we have in my state New Jersey over 7 000 cases for which I'm lead counsel and I've tried several of these cases and spent a great deal of time so hopefully the information I can provide to you today will be helpful for you in considering the way forward on these very dangerous devices which in my experience now the closest analogy I can find is asbestos something that was thought to be a wonderful invention for a long time and now everybody in the world knows it's something you wouldn't want to go anywhere near and it's the closest analogy I can find to these horrible devices that are now in so many women's bodies so thank you I'm ready to answer any questions you might have well thank you mr slater and I will ask the first question you did mention here that some 7 000 devices have already been implanted in the USA and can you tell me what recent data is available on the number of these that result in medical device reports what I can tell you is this one of the benefits we have of litigation is that we get to see the internal documents from the companies documents that they have not shared publicly and for example johnson and johnson which is the largest manufacturer they state in their documents that they have these devices in over 2 million women the 7 000 number is the number of women that have filed cases in the state of new jersey there are about 70 000 or more cases filed in the federal courts that are placed in front of one single judge in the state of west virginia and there are very many more cases filed in various other state courts that nobody's been able to count and I can tell you there are probably tens of thousands of other women who have been harmed who either don't know they can bring a case or their complications haven't manifested yet or in many cases women found out too late that they had a case and they can't bring it so you're talking about millions of women according to the data from the manufacturers themselves okay can you then say advise me what grounds on which the patients have sued yes there's two very basic claims that will be seen in any lawsuit one is that these devices are defective and that generally means they are unreasonably dangerous what doctors do is they balance the risks against the benefits and unfortunately the companies essentially created a market for these products by having their doctors who consulted and were being paid by them to speak at national conferences and publish articles saying that suture repairs which has always been the tried and true way of treating these conditions were not effective so they needed these mesh materials and they began to use those the studies that I think you can rely on where there's not industry funding behind them show that there really was not a need for the mesh and in fact it doesn't work any better when you take the that's the benefit side when you look at the risk side the risk or catastrophic complications that for many women cannot be treated so when you put those two together and you say the risk outweighs the benefit you have a defective product the other claim is failure to warn doctors and patients have never been given the full story of the complications and the dangers they know of publicly how do I know that because I've read the internal documents of these manufacturers and I've seen the unbelievable internal conversations and everything I'm telling you by the way is now public I've tried these cases these documents that I'm referring to are not confidential any longer this is public information although it hasn't been widely disseminated and internally for example at Johnson and Johnson they talked about running a registry where every woman who would get a prolift which was one of their products would be counted and they could follow their progress the medical people within the company said no we can't do that because then our risk and complication data will become more accurate which would bad for sales and that would be bad for competition so unfortunately that's the thought process within the companies so those are the two main claims the women are not warned and their doctors especially are not told the truth about how serious the complications are and how untreatable they are for so many women and the products are defective it's unsafe to put polypropylene mesh in so many women can you advise mr slater of the core actions that are pending is it the manufacturer who's been sued is it the clinician who's been sued or is it both and what has been the outcome it's a great question it's both it depends on the court it depends on the the client and the law firm that file it I just tried a case last month where both the doctor and the manufacturer had been sued and many doctors are caught up in this because they didn't have the full information and they believed what they were told by the manufacturers about which women were appropriate women to have these put in their bodies they basically said any woman's a good candidate and doctors believe that now when you look at the internal documents it doesn't bear out so there are doctors that are having lawsuits brought against them now it's not as pervasive there's a thought process in United States litigation that you don't want to get the doctors angry by suing them that was the thought process early on but more and more people now are suing their doctors because the doctors turned a blind eye to good data and instead just believe propaganda and that's a problem for a doctor okay can I ask Angus McDonald question thanks convener good morning again mr slater we're aware that the fda regulates the use of medical devices in in the usa now on the 29th of april last year the fda issued proposals to reclassify surgical mesh for transvaginal a pelvic organ prolapse from a moderate risk device class 2 to a high risk device and require all manufacturers to submit pre-market approval application for the agency to evaluate safety and effectiveness has the fda proposals to reclassify these products come into effect and what's been the effect of any regulatory changes on the medical profession the regulators and indeed the manufacturers it's a good question i'll give you a three part answer the first part answer is that the fda has not issued those orders yet which is quite disappointing and unfortunately it's typical of the regulatory authorities in the united states they don't move quickly and unfortunately there's a collaboration between the fda and the medical device manufacturers i've seen it in the internal documents before the fda issues pronouncements about mesh for example they are consulting with the medical device manufacturers and they're being lobbied so there's a close relationship there and it's unfortunate and it it takes the fda away from the neutral objective position it should hold so the answer is that it's just sitting in limbo and nobody knows why um what is the fda done that has been positive well when they issued what's called 522 522 orders in early 2012 the result what they were saying to the manufacturers was you have to study these products more and we want to see real studies robust studies and that was a good thing and many of the manufacturers pulled their products off the market instead of having them studied by these robust what's called randomized controlled trials it's a very damaging fact against these manufacturers and i've seen the internal emails for example at johnson and johnson again these are public when that when the orders were issued by the fda the very day they were issued the regulatory affairs professionals at ethicon and johnson and johnson were already asking if we pull the product off the market can we avoid having to do these studies and products were pulled off johnson and johnson for example pulled four of them off the market both incontinence and prolapse devices rather than doing those studies and the conclusion there is there's never been a high level study like the ones the fda mandated that's ever been done that's proven the mesh to be safe and effective that's never happened um the third thing i'll tell you again kind of harkening back to my first is it's and it's maybe it's the cynical side of me from doing this for a long time but there's an expert for johnson and johnson in the mesh litigation who used to be a head of enforcement in the fda and we learned in his deposition that he actually side switched in a matter where they were investigating a johnson and johnson company over a product and then he switched and became a private consultant on that matter for the johnson and johnson company on the same matter so you draw your own conclusions but but we who are a bit cynical don't really look to the fda as as an entity that has the resources or the structure to be able to actually protect women or other patients for that matter in this area okay thank you um you mentioned that the reclassification hasn't actually happened yet have the fda given any indication to yourself or publicly as to when the reclassification will happen or come into effect i i've seen nothing that indicates that they have given a a time when they're going to do it i'm you're familiar with the documents and you're familiar with this so everybody expected this was going to happen quickly because we're talking about the health and safety of women and you should think they would move quickly we have no uh indication of when they're going to act i will tell you in practice because of the information that has started to come out there are many doctors who are treating the products like high risk devices even without that classification and there's many doctors who now refuse to use these devices because they're now learning unfortunately what we've found is that many women when they have a complication they leave their doctor so their doctors think they're having wonderful results because the women aren't returning to them the thing is the women are going and finding the most high level pelvic reconstructive surgeons usually doctors who don't put mesh into women's bodies to remove it and there are studies published by male clinic doctors in minnesota there's a recent study the first name of the uh listed author is abbot where they recognize this across the board that women typically do not return to their doctors when they have very serious complications they go elsewhere so doctors don't really know this fortunately it's getting out now and many doctors are avoiding these products and and that's a good development thank you mr slater it's good to have on our record that clinicians in the states are now refusing to use the the implants at least some some clinicians thank you john woson thank you good morning mr slater the medicines medicines and healthcare products and regulatory agency in the uk continue to argue and in a recent report the benefits outweigh the risks what would be your advice to that regulatory body what i would tell them is to look at the studies that are relied on by the mesh manufacturers what you'll find is a few things one most of the studies they rely on are written or investigated by paid consultants so i would throw those in the garbage immediately because if somebody is being paid by the manufacturer there's a financial bias and that's recognized in the scientific literature financial bias affects conclusions that's number one number two the very grandfather product in this area is considered the tv t by johnson and johnson and the studies of the tv t in the late 1990s are really the bedrock studies supporting all the mid urethral slings unfortunately what people have not known is for example in that study the lead investigator and the inventor of the tv t was a dr olmston european doctor doctor olmston's contract with j and j had a clause in it that if he reported certain complications he would lose a 400 000 payment that's in his contract that's acknowledged and the studies by nielson which are the 17 year long term studies well we turned out in discovery those are the same patients so you had data that was paid for and our discovery and our investigation has shown that and i could send you reams of testimony on it so the bedrock studies are not reliable the studies they look at safety is never the primary end point of those studies they don't study safety the way that they should and in a robust and objective way rather they look at well are you going to get yes less leakage are the organs going to stay in the right place better and modern concepts of these types of surgeries recognize that the most important thing is how does the woman feel because this is elective surgery that nobody needs how does the woman feel and after these surgeries what you'll see is with the native tissue the suture repairs the re-operation rates are far lower than the re-operation rates with mesh and the functional day-to-day life outcomes for the women are the same or better with the suture repairs and study after study bears this out the only thing the manufacturers can say is well with some of these mid urethral slings we have some studies that show that a woman will remain dry for a longer time but at what cost and the studies don't in a robust and thorough way study safety and i can tell you from the internal documents for example from ethicon they admitted in depositions that the risks include and and i'm quoting them life-changing complications recurrent complex erosions contraction of the mesh causing pain syndromes these are things that are not in the warnings for most of the manufacturers their sales representatives will tell doctors that they are not serious risks and therefore when somebody tells you the benefits outweigh the risks you have to look at the women who are suffering the catastrophic complications and it's easy to say well that doesn't bear out in reality mr slater are you aware of the exchange of information between the us authorities regulatory authorities and other authorities throughout the world including the uk i'm not aware of the fda sharing information with the uk or european regulatory authorities i've not seen any documentation that that has happened if it has i'm not aware of it but i think that ultimately all of the regulatory authorities are we have a saying in the united states and i'm sure you probably have it over there you're fighting with one hand tied behind your back at the regulatory authorities they're they're not funded the way that they would need to be and there's only so many resources to go around so you can only do so much and the key information has not been shared so the regulatory authorities don't have the full information and again look at the influence of the mesh manufacturers on these authorities they meet regularly they speak regularly when something alarming is brought to the attention of the fda i've seen many documents showing they immediately pick up the phone and call the people at the manufacturer and say hey what's this so it's not an arms length objective process unfortunately thank you very much indeed thank you very much and good morning mr slater under the current european union relations manufacturers role is the responsibility of the frame in the framework is clear what role do manufacturers have within the us regulatory framework in both pre market and post market scrutiny of their products it's a great question in the united states these mesh products were able to get on the market through what's called the 510 k and that's a essentially an exception to the rule that says you have to actually get robust pre market approval these mesh products got on the market with basically a simple application that said this is and the buzzword the regulatory word is substantially equivalent to something else on the market so what they said is well this is similar to hernia mesh or this is similar to another mesh many of them used as their what they call the predicate the earlier product something called um it it was a product by boston scientific it was a mid urethral sling that was recalled from the market but companies were able to rely on that to get on the market and their approvals were not touched so it takes very little for these mesh products to have gotten on the market and as i was asked earlier the robust protections that are used for drugs have never been instituted yet for these meshes when they were threatened to have to do the types of studies you should have to do to get these on the market many of these products got pulled off the market instead of doing the studies as i mentioned earlier so it's a very very easy process compared to getting a drug on the market for example these products have never been scrutinized the way they need to be thank you for that how might this affect clinics and health care providers the view of the information that the manufacturers have provided of their own product well unfortunately what happened is many physicians and hospitals said oh this sounds great let's stock it and let's allow it to be used um that obviously hasn't worked out well i have not seen an analysis of the cost to health care authorities and insurance companies but i will i would venture to guess that the numbers are going to be staggering because if you look first of all to put use a suture to repair these conditions is not that inexpensive a procedure the mesh is very expensive so for example in your country your government's paying for that and then when a woman has complications now she has to go and she has to have more examinations because the mesh is eroding or it's contracting and every time the doctor sees the woman that's another exam and now you're going to do an ultrasound and try to image it and then you're going to do a surgery to try to find it and what the the data also shows is once a woman has surgery odds are she's going to start to have more surgery and more surgery and for example that's the habit article i cited to you that women ends up with multiple operations and the complications are bad so now you have multiple hospitalizations so you have staggering compounding increasing costs to your government for this health care and these clinics they don't have the wherewithal so there's only a few places in the country where you can go and find doctors that actually are equipped to remove this mesh and i'll tell you i talk to these doctors all the time who remove it they still have not established a safe and effective way to remove mesh from these women i had a doctor the other day tell me that some of the hardest surgical scissors that they used to remove mesh are not effective and they have to use tools that they never imagined they would use in a woman's body to remove this because it's so tough and so difficult to remove you won't find that information being given to doctors or the clinics even today thank you and what effect has this litigation have on the role of the manufacturers in the US regulatory framework i know you've touched on it just briefly but just to recap on that could you possibly expand on that a little sure what the manufacturers have done is damage control from the very start and again i've seen the internal documents as soon as the FDA came out with their first public health notification in october of 2008 the manufacturers were putting out talking points that day saying well this is nothing different and then the next public health notification came out in july of 2011 and then the meetings in september with the FDA and what what the companies did is they had very polished members of their industry speak and try to convince the regulatory authorities everything is fine and testified contrary to what their internal documents showed which is frustrating and frustrating for any one of us who looks at the situation they've continually met with the regulatory authorities they've delayed action they have continued to peddle bought and paid for studies studies run by their own funded consultants and and the FDA which again because of the way that things are structured works in tandem with these manufacturers and they feel like they need to do that on a day-to-day basis we'd prefer to see them be at arm's length and be show much more scrutiny but the manufacturers considered to continue to play their game and i can tell you what i've been told by the manufacturers many of whom don't want to settle these cases hey there's no court that can handle all these cases so let these women wait and that's what i've heard so that's their attitude and i and i implore you you know you're going to see a lot of women in your country and the justice system needs to be beefed up and there need to be special courts to give these women justice in a in a quick and efficient way because in the united states we have 70 000 women or more and most have no hope of ever getting a court date or getting their case heard and it's really tragic because you have women who are bankrupt losing their marriages suffering they can't afford their medical expenses and and they really don't have any light at the end of their tunnel unfortunately thank you very much indeed thank you do you finally yeah um we've just heard from the regulator the UK regulator who's looking into this and um it would appear from their evidence that they suggested that the they wouldn't say that the problem or any of the problems were associated with the product they spoke about the product being fit for purpose and that the benefits outwead the risk looking at some of the list of the cases that have been settled in the us it seems to be that most of them appear to have been because of defectively designed products is that the case or is that just the ones that i'm looking at that um that's the reason no you're you're correct when the cases have gone to trial and a jury has decided the case the plaintiff has won almost every single one of them and in every case uh that's been one they've either found in most of them it's been that it's a defective product and the other part of being a defective product in the united states law is if the warnings are inadequate uh that's considered a product defect as well because that means the doctor and the patient weren't able to balance the risks and benefits and and one of the things you'll see is when these cases actually get to a courtroom and our hands are tied to a large extent by the evidence rules for example i try these cases i have not yet been able to tell a jury that products i'm trying cases against have been withdrawn from the market by the manufacturer i haven't been able to tell a jury yet and this is again information that's been filed publicly that johnson and johnson and ethicon destroyed tens of thousands of pages of documents regarding their mesh products haven't been able to tell a jury that um and the judges are doing the best job they can under the evidence rules we have an intellectual disagreement i think that a jury needs to know that that's certain of the medical directors at ethicon who allowed their products to get on the market their entire hard drives were wiped clean and we never saw one of their internal documents um it raises questions i think a jury should be able to hear that uh so when juries do get to hear the evidence they actually do get to hear what do they do they find against the manufacturers and the verdicts have uniformly been in the seven figures and they've awarded punitive damages in several cases which are damages in the united states to punish and send a message to these companies so again i would tell the regulators if you want to know what's really going on you need to take the time and i tried to send documents and to the parliament and i understand you have certain rules that you're not allowed to keep those on file but if you wanted those documents i'd be happy to send you reams of deposition transcripts sworn depositions video depositions of medical directors internal documents let the regulators look at that let them look at the inside truth in the emails when people wrote emails eight years ago and didn't know that this was going to end up in court when they were telling things in a candid way to one another within the manufacturers tell them to talk to the doctors who are removing the mesh tell them to talk to them don't talk to the doctors who have a financial stake in seeing these products used talk to the ones who are removing it who don't use it they'll give you the most honest objective information like the doctors at the male clinic who wrote about these catastrophic complications and i'd be happy to have those studies emailed to you today you can see them and you can see all that information i would welcome that definitely would welcome that could so just to be clear on that you your clients have received compensation payment even though the product has not been withdrawn from from use there are women who have with who have been well it's funny received compensation there are some women who have settled their cases and they've been settled on a confidential basis so i'm not allowed to talk much more about those but the public jury verdicts have been both against the withdrawn products and the products that remain on the market it's not been limited to the withdrawn products in fact the mid urethral slings sold by both boston scientific and johnson and johnson and ethicon have been the products in which plaintiffs have won trials in various states including texas including the federal litigation in west virginia including a federal case that was in florida so it's not just the withdrawn products and i'll tell you one other thing because you asked me about what the regulators should look at they're going to be shown studies one of the things we learned in our discovery the new england journal of medicine is considered to be maybe the most prominent medical journal in the world or at least they bill themselves that way through our discovery we were able to show that a study published about one of johnson and johnson's mesh devices that ethicon had significant involvement in the design of the study the analysis of the data and the writing of the manuscripts yet the author had said that there was no involvement in any of these things and when i took the deposition of the editors of new england journal of medicine i had got caught a court order from the state court judge in the state of massachusetts because they fought me like crazy we not only found out more about that which is that there was not a disclosure of involvement by industry but that certain of the data was unreliable because the measurements done of women's repro laps had not been done in a valid way and that entire study was invalid in the opinion of our experts that study still sits on the books so again when you see published studies and i would tell that to any regulator look with great scrutiny look with great scrutiny at those studies two final things one is that we have a national health service here different health service from you have but what do you think as an outsider looking in is the are the implications for our national health service financial implications for our national health service of this well i think i can say it in very basic terms surgery with mesh is more expensive the consequences are incredibly expensive because women need intensive medical care when the complications happen there they will tell you oh well if a woman has some erosion of the mesh it's not that big a deal it can be easily fixed well that's not what the data shows it shows that over 50% of women need surgery and that as i told you the studies show that women end up with multiple operations and by the way this is a lifelong risk and as a woman ages and her the tissue of her body ages she's at a higher risk for the mesh contracting and eroding so it's a risk that's going to go on and i had in deposition testimony with a doctor from california who's maybe removed more mesh than any doctor in the united states of the world his name is shlomo raz r a z he's a very highly published highly respected urologist and pelvic reconstructive surgeon he referred to it as a social cancer in sworn testimony and he's somebody who used to use the mesh and he said when women started showing up seven and eight years later with complications he looked at this and said you know what i can't do this anymore and he has ceased putting this mesh in any women's bodies and all he would do is cut small pieces and put it into a woman's body not these large kits not these kits for the urethral slings he was using smaller amounts carefully placed and he has stopped using it so what's the implication it's going to be costly and every time a woman gets this you have a 50 50 chance that she's going to be someone who's going to need a lot of care that's what the data shows one final thing i'm glad you mentioned the conflict of interest that it was one of the things i wanted to raise with the regulator but didn't have time it appears that this whole issue is riddled with conflicts of interests between the manufacturers and doctors various different clinicians the regulator whether that be in the us whether that be in the uk europe throughout the world this whole thing seems to be wound up in a whole series of conflicts of interests is that something that you know you would agree with i would agree with it 100 percent in fact i'll tell you something that's very shocking again i referred to the internal documents from the manufacturers i'm a lawyer and when we get those documents that means a lot to us so maybe i'm a little biased on it but that's what they said internally when they didn't think anyone would see it and i'll give you a great example the medical director at ethicon is a doctor named pete annull a belgian neuro gynaecologist he was hired by ethicon and johnson and johnson and in an email he talked about one of their highest paid consultants a dr vince lucente who's been paid 1.7 million dollars by the company and he said when his group publishes that they have no erosions nobody believes that so he's essentially saying they're publishing false data while at the same time one day before the company authorized $400,000 in payments to that same doctor because he was so good at marketing the product to other doctors and again this is someone who's published studies saying he had no erosions on multiple occasions and the doctors within ethicon know that's not true yet they use them to promote the product to speak at national professional societies to publish literature and then they use similar types of doctors to lobby organizations i'll give you another example the american college of obstetricians and gynaecologists published what's called a practice bulletin in february of 2007 calling these procedures experimental the internal documents show that this same doctor lucente and other doctors that were paid consultants lobby behind the scenes because they were worried that the insurance companies and medicare and medicaid our government payers would not pay for experimental procedures they got a cog to change that and remove the word experimental in 2007 the email showed this doctor lucente writing to the marketing people at the company saying this is a great victory and the email from the marketer at ethicon says i love you man i'm doing the happy dance because and every one of these emails talks about we're going to be able to get paid for these surgeries there's not one word about women's safety or health or whether it was right to call them experimental and absolutely it was the right thing to do and by the way one of the other lobbyists for ethicon at the time one of their consultants she now works for regulatory affairs at acog lobbying the fda so i have all those documents none of them are confidential anymore if you want them i have them here for you i look forward to receiving them from you thanks mr slater just one final question obviously you've been heavily involved in the over the past couple of years have you at any given time been approached by our regulator to provide any evidence or any information indeed in turn have you ever offered any evidence or information to the regulator the regulatory authorities in the united states have never picked up the phone and called me they've never asked for information from me to my knowledge i'm not aware of them asking any of the attorneys that are involved in this litigation for such assistance so the regulators have step stayed far away from people like myself who would be more than happy to give them all of the internal documents i've obtained to show them the true story they haven't asked for it which is a shame would that same offer be made to the uk regulator i'd be happy to provide anything that's requested i have everything here anything that is no longer confidential and i've dutifully battled to designate documents and make them not no longer confidential i'd be happy to provide those to anybody who asked just one final question on that have you ever approached a regulator to to offer that evidence i have written to the regulators and provided information i've never been approached no have you approached to regulator i've offered to provide information i've never been approached had somebody say to me yes provide us anything any further questions mr slayer can i thank you for giving evidence on this petition and can i also apologise for keeping you late and but you're probably aware that there is a great deal of public interest in this petition and so again can i thank you for providing that your evidence and it was very much appreciated and you can go and have a happy day i appreciate the opportunity because there's a lot of women who really need people to stand up for them and i think that ultimately it's it is the politicians and it's the members of parliament in your country who need to stand up for them because they really don't have anybody to really battle for them and i just i feel honoured to be able to to do this for them because i know how hard they're working there in scotland so thank you very much thank you we'll now ask a committee to decide on what action it wishes to take on this petition members have a note by the clerk that sets out the possible course of actions what are the members' views do we agree then that we we draw the that the committee draws to the Scottish government the attention of the evidence heard with request that is taken account for a review and we have also agreed that we are going to meet with the cabinet secretary the chair of independent view on transvaginal mesh implants and the european commission does the committee agree that this should be after the publication of the independent reviews findings neil that you do the committee to do one other thing and that is to ensure that the documentation that mr slater has offered is sent to both the Scottish government and the mhra and i don't know whether the Scottish government then has to look at that and then make a reassessment of where it is or whether the Scottish government needs to pass that on to individual health boards it might be that when the cabinet secretary comes we can we can hear what our views are on the evidence that mr slater produces but i think we have to take into account the the i think very substantial evidence that he's going to provide and that has to be part of the committee's deliberations because that will given that he's saying that there are internal documents from the manufacturers that show in his view some very serious things then i think that would be something that the committee would want to know well i think that's right right for important so the action that we'll take in is that we will take today's evidence pass it on to the Scottish government for information we're going to have the cabinet secretary and others on for further evidence i'm quite sure that everything that was said to you today will be part of that report part of that evidence session so can i think just the evidence that mr slater's going to provide could that be provided to um for example myself as well as committee member and also to the um to the mesh group just been advised when that comes on you but we'll review that i'll come back and let people know okay so i know from the close of meeting can i thank the gallery for being here and you know that it is got certainly public interest and hopefully what you've heard today well it might not be the solution at least it's it's probably more evidence that we can take into account for future for future evidence sessions so thank the public gallery thank the committee members and now for me to close the meeting