Good afternoon and welcome to the Women and Equalities Committee. Today we are holding the third of our evidence sessions on the health impacts of breast implants and other cosmetic procedures. I am very grateful to our first panel. We have Professor Aidan Fowler, national director of patient safety at NHS England and Deputy Chief Medical Officer for the Department of Health and Social Care. We have Dr Alison Cave, chief safety officer from the MHRA, and Andy Morling, deputy director for criminal enforcement at the MHRA. Welcome to you all and thank you very much for being here. I am going to hand over to Christine.

Good afternoon. Thank you for coming along. First, I would like to ask all you about the latest NHS guidance, which says that “Ruptured PIP implants have no proven long-term health effects.” Researchers we spoke to, and evidence we have heard, described that position as ludicrous so are you still confident in that guidance?

I do not think we have said that ruptured PIP implants do not cause effects and symptoms; we have said that there is no evidence of toxicology related to PIP implants per se. That position has not changed from the report that Sir Bruce Keogh wrote back in 2012, where the advice was that ruptured implants should be removed. They certainly can cause symptoms, although they can rupture silently. We know that these implants rupture more commonly than other implants—at a rate of two to six times—and they use non-medical grade silicone. But the toxicology shows that actually the composition of that did not carry long-term risk per se. The advice is that you should have an annual check-up and the advice remains that. You may have it explanted if you are anxious about it or if it ruptures, and while normally we would encourage people to go back to the original surgeon who carried out the procedure, if people are unable to do that or if they are refused treatment, then the NHS would explant the implant at their request. That guidance remains, but it is very clear that if these rupture, they should be removed.

I could add a little further detail from the perspective of the MHRA. Obviously we are continuing to look at any evidence as it emerges, but we have no current evidence that PIP implants carry greater risk of either cancer or other symptoms than any other breast implant. I would just refer you to some investigations that were done at the time of the incident, which is back in 2010 to 2012, and in 2010 they were removed from the market. There was a specific analysis of the implants undertaken in 2012, and then subsequently again in 2013 by the European body, which is the Scientific Committee on Emerging and Newly Identified Health Risks. It looked at the composition of the breast implants, including the presence of these cyclic siloxanes D4, D5, and D6, which are actually commonly present in a number of domestic products, and they concluded there was no convincing medical toxicology or other data which would justify removal of these implants and there is no additional increased risk from these implants versus others. Although of course it is quite well recognised that the rupture rate of these particular breast implants is higher—you will have heard figures of two to six-fold—it is probably quite useful to put that into some sort of context. That rupture rate is apparent after five years, and it is probably useful to contextualise that by what it is compared against. The rupture rate for other brands of silicone gel implants is about 0.2% to 0.4% at five years, and about 0.5% to 1.1% at 10 years. The increased rupture rate that has been identified for the PIP implants is about 1.2% at five years, and 3.1% at 10 years. So it certainly seems to be higher, but it is just a useful context in terms of what it is compared against.

Given that higher rate though—and you mentioned women who have ruptured implants—and the fact that there are women who still have PIP implants who say that they are causing them physical pain and mental stress with the fear of rupture, but they cannot afford to have them replaced, do you think the NHS should be offering explants to women who have implants which are causing them this stress and pain? Do you think that should be the case?

The NHS offers explant to people who have pain or indeed where they are causing anxiety. There were a very small number of PIP implants put in related to cancer surgery or some other very specific cases by the NHS—888 out of a much larger total—and in those cases we would replace the implants. However, the NHS will not replace PIP implants that were done for cosmetic purposes, but it will explant them. So the difference is it would not replace them.

Can I just check because as I understand it the majority of implants were not done by the NHS?

That is right. About 47,000 implants in total were done, of which 888 were NHS implants.

So if women are stressed or in pain, you will replace those?

The advice is to go to your original surgeon for any concerns. If that is not possible, the NHS will take on your treatment for pain or other symptoms, including anxiety, but it will only explant, not replace.

You would not replace those ones, but you would replace the ones that the NHS put in.

We would replace the ones that the NHS put in if requested, and that is a very much smaller number.

Alison, you talked about there not being as high a risk as perhaps has been explained to us in previous sessions by healthcare professionals. Why is it that the UK decided to take a very different approach to PIP implants to France, for example, and other European colleagues? They took a much more proactive stance in contacting women who had PIP implants and they offered to remove them, whereas the UK took a very different stance. Why is that?

As part of the surveillance that the MHRA did back in 2007 to 2010, it worked with the NHS and other healthcare partners to ensure that it was appropriately investigated. I can give you some examples of the work that was done at the time. It contacted all the major implanting centres in both the NHS and private sector to ask them to complete a questionnaire because it wanted to understand the context in which they were working. It looked at the total number of women who had had these implants, the reasons why they may be explanted, and it looked at the clinical findings. In total, the MHRA collected information on around 240,000 implants across all the different operations given to 135 women and looked at detailed explant information on 5,600 operations. I explained that the toxicological findings were that there was no increased risk of health issues compared to other breast implants, but of course the rupture rate was a concern for women—I explained it was higher—but it is useful to contextualise that with the baseline rate. We advised that if the women were concerned, they could be removed if they go back to their operating surgeon, as Professor Fowler explained. Of course we need to remember that there are risks. The risk of explanting breast implants is not trivial and the risk of removal of them is not trivial, so there has to be a benefit-risk discussion, and we came to a risk-proportionate decision on what was the best advice, and it is not aligned with many of the international regulators either.

So it was not just about the rupture rate, it was also about the quality of what was inside these PIP implants. From what I am hearing, you felt that you knew better than France and some other countries in the fact that it did not need a proactive stance. Many women who have had breast implants will not find the idea of having them removed and not replaced an attractive option. Why is it that you took that decision?

As Professor Fowler has talked about, it is the reasons for the original operation. If it was a cosmetic operation, then it was advised that if women wanted them to be removed, then the NHS would do that if the original supplier would not. Just to reiterate, if the NHS had done the operation in the first place, then it would replace them.

But that is a very small number with respect to the number of people who have breast implants. The ones that were done on the NHS is a tiny proportion in comparison to the numbers of women that have breast implants privately. I am going to ask again: why do you think that your approach was the best one in comparison to other countries? Was it that there was a calculation that you felt that the risk was not worth it? Why was there a decision not to offer women a replacement, which would actually probably bring forward many more women than those who were just to have theirs removed without any replacement?

It is a different question, if I might say. We would give advice on the benefit-risk of the particular product. In this case, if the women wanted them to be removed, then they would be removed. But it is not up to the MHRA to advise on the onward mediation or the onward recovery of an operation that was undertaken. The risk of the product was if the product was still there and women were concerned about it. Whether it should be replaced or not does not talk about the benefit-risk or the safety of that product.

Let me try again, with something different. If you felt that it was advisable that the NHS remove PIP implants from women who ask for it, you surely felt that there was a risk. So why is it that it was the onus was on the woman to assess that risk herself and not the MHRA to protect women’s safety when it came to implants that they felt were safe and had consented to be safe? Why is it that if you felt that it was dangerous enough and worrying enough to offer them to be removed, why did you not offer that more widely in a more proactive stance?

I think it was offered to women. They were offered that if they wanted to have them removed, they should contact their surgeon; I would just reiterate that. It is not for the MHRA to advise on the onward management of that clinical condition. That would be an NHS England position.

There was an expert group convened to look at this and I am aware that there was a difference in position between countries. We took more of the stance that for example Australia took, and Australia did some of the research into the toxicology. In fact part of the advice that was given to the Keogh review was from the Scientific Committee on Emerging and Newly Identified Health Risks—bit of a mouthful—which is a European Commission group and 1.6 says, “There is currently no convincing medical toxicological or other data to justify removal of intact PIP implants as a precautionary approach.” So they were removed for symptomatic reasons because it was felt it was not justified otherwise to put people through a procedure which is low risk—but not no risk—and anaesthetic. In Professor Keogh’s report, I know he looked at anaesthetic risk, and on the basis of numbers they calculated that there might well be a death relating to the anaesthetic alone, plus the effects of surgery. So they were balancing risks here and making that decision and balancing on the basis of—

Yes, I guess that would be a far quicker death than cancer, say.

But there was no evidence that there was an increased cancer risk.

Okay, I do not feel that we are getting where we need to get to because when I asked the surgeons we have had evidence from if they would ever recommend anybody get a breast implant, I was very surprised when they said, “No,” given this is their bread and butter. They feel that there is not enough data and research done into the long-term impacts of breast implants. I am going to pass on to Christine. Q126 Christine Jardine I am afraid my question actually follows on very much the same. You have said that if women feel there is a risk, you will remove the implants. You contextualised that there is an increased risk of rupturing in PIP implants. What I do not understand—and I think I am thinking the same way as the Chair is—is that if there is a risk to women’s health, however small it is, should the NHS not be offering them the opportunity to have them removed in any event? You would be preventing the possibility of an illness and expensive follow-up medication from the NHS, although I do not like to bring it down to economics. It would be a preventative and potentially cost-saving method to say to every woman who has a breast implant, regardless of how she got it or why she got it, “We think you should have this removed and replaced.”

We would be offering removal on the basis of symptoms, not risk, because there is not sufficient risk to justify explanting them all, as we have said, such as cancer risk. But if people have symptoms, we would remove them, and if they rupture, we can still remove them and there is not a long-term impact established from rupturing.

I am going to move on to Kirith now, but I wonder how much work has been done on the impact of that rupturing in the long term?

My question is for both Alison and Andy. How does the MHRA monitor the safety of breast implants particularly in light of BIA-ALCL and concerns around symptoms known as breast implant illness?

As we do for all medicines and medical devices, we monitor the safety under our post-market surveillance activities. We have a number of strands by which we might do that. We run the yellow card scheme; we accept reports from all patients, members of the public and healthcare professionals on any concerns that they may have in association with breast implants. In order to improve our follow-up for that, we have put in place a smart form so that we can collect more information. In conjunction with our expert committee, we have developed a questionnaire to follow up on some of the specifics we may need, for example, if we wanted to ask if there was a case of breast implant-associated anaplastic large cell lymphoma, the BIA-ALCL issue. We would follow that up closely. We would confirm all cases against the WHO criteria, and we would then monitor those and try to follow up on the outcome. In addition, of course the manufacturer also has significant responsibility for the safety of its product on the market and we expect it to comply with all its obligations, which would be monitoring the safety of their products on the market, looking at any follow-up, literature or any other information that may come out about its product. So we have a number of strands of information. I would also note that actually just last month we strengthened our post-market surveillance legislation with a new legislative framework which places more responsibilities on manufacturers that have medical devices on the UK market. It includes post-market surveillance plans, which include stricter requirements about when and what must be reported, as well as information about what happens globally. For example, if it has a notification in another country, it must inform us of that notification. There are a number of ways to strengthen that post-market surveillance, which is incredibly important because there are always issues which emerge a long time after the event—being exposed to a medicine or a medical device—which the original clinic investigations cannot capture.

What work is taking place on the safety of siloxanes and their impact on the human body?

As I mentioned at the beginning and Professor Fowler iterated, there is currently no toxicological evidence, medical, or other data to indicate that these products carry an additional risk. As I think you have heard previously, they are contained in a lot of cosmetic and other domestic products which are on the market. We have a derogation now in place that they should not be in medical devices going forward, just as a risk proportionate approach, but at the moment there is no evidence that these particular siloxanes carry additional risk and that has been carefully looked at. We will of course continue to monitor any new literature and any new information that is published, and we monitor very carefully all the reports that come into us.

We have been told that there is enough evidence to suggest that women who have an autoimmune issue—asthma for example—are at a greater risk of developing problems following breast implantation. Do you recognise those concerns and what research is happening in this area?

I think you are talking about breast implant illness, which is a term used by people to describe a constellation of symptoms that they report: fatigue, pain, hair loss, joint pain—a whole range of conditions that are grouped together into a term called breast implant illness. It is currently not a registered illness as such, but we absolutely recognise these reports and monitor them carefully. As an example, since 2008 we have received about 1,000 reports of a variety of health problems which might fall under this particular banner or this particular characterisation. But again I would put that in the context of how many operations have potentially been performed in the UK over that time period. Currently, the BCIR registry—the Breast and Cosmetic Implant Registry—reports about 20,000 operations a year. If you think about that in the context since 2008, that might be 300,000 or more operations that have been performed, and we have about 1,000 reports. I am not pretending that that is probably the total sum; we totally acknowledge there is an under-reporting, but we are looking at maybe about 0.5% if you look at it in that context of operations where we have reports of this particular illness. So we are looking carefully and following it up. From our evidence, it does not seem to be limited to a particular manufacturer or a particular type of implants, whether it is silicone or saline-filled implants, or smooth implants or textured, rough implants. Currently, there is insufficient evidence to try to stratify which particular implant may be associated with this particular constellation of symptoms. We are trying to conduct epidemiological studies to see if we can proactively detect more reports looking at real world evidence and trying to draw out reports in that data of women who have had breast implants and may be suffering consequences subsequently. But interpretation of those is currently limited by a number of factors partly due to the non-specific nature of those symptoms making it actually quite hard to draw that out of real world data, which is because of the different prevalence of those conditions. You can imagine fatigue could be associated with a lot of illnesses that are not associated with a breast implant, so they are actually very hard to capture. I just want to reassure you that we are actively looking at that and trying to find ways where we could capture more information about this particular syndrome.

Just to go back to Kirith’s question: is any actual work currently taking place on the safety of siloxanes? We know the EU is banning the siloxane D4 next year, but not for breast implants; it will not be in cosmetics but it will be in breast implants. Have you taken a view on that?

Currently, as I mentioned, there is a derogation which says that it should not be in any medical devices. I would have to come back to you; I am happy to come back to you with any further information on that EU decision and what our current position is on that.

My questions are around how the NHS makes sure a patient is able to give informed consent to a breast augmentation, particularly given the lack of data on associated risks, as you mentioned. What follow-up care and post-surveillance is given to patients who have received breast implants from the NHS?

There is follow-up for those on the NHS. On consent, there are very specific guidelines, both from the Royal College of Surgeons and GMC, on how to take consent and giving advice. As you all know, the Montgomery v Lanarkshire decision meant that high-risk low probability risks are also advised—they would be advised for example about the BIA-ALCL—so we would expect that they would be given all the advice available and informed at the time that there may be risks that we do not yet know about. Best practice is to give people who are expected to have cosmetic surgery a cool-off period to think about and seek evidence on it. There is also NHS guidance on having cosmetic procedures—including implants—and what to ask about it to try to guide patients and support them through that consent process. There is also follow-up for those on the NHS.

I would just add that the MHRA has done quite a lot of extensive research into how patients perceive the risks of breast implants. In the autumn, we are launching a cosmetic breast augmentation risk assessment form, which healthcare professionals can work through with the women to make sure that they receive all the information, and it provides a structure in order to aid those conversations about risk between the patient and their surgeon

Would you be able to share that with the Committee when it comes out?

Of course.

If a report came in to us about a breast implant, for example, we would absolutely look at that report and monitor it and try to follow up on it. I think you may be talking about dermal fillers or other cosmetic procedures and that is quite a complex area as to whether it is designated as a medical device or not. But we would rarely get that information on a report and would absolutely follow up and accept reports around dermal fillers through our system.

I do not think so. It is quite complex, but a medical device has to have an intended medical purpose—in that case it would not—and then needs to be registered as such and go through the necessary procedure in order to register it.

As I said, we have a number of ways in which we do that; we already discussed the yellow card scheme, and we actively encourage all patients and health care professionals to report to us about their experiences with any medical product—be it a medicine or a medical device—and we will actively follow up those reports that come into us. As I have mentioned, it is not just the yellow card report; we have a holistic view. We monitor the other literature reports coming through that might indicate a safety signal that we are not potentially capturing through the yellow card scheme. We have placed obligations on manufacturers in order to report to us. We also have good communication with our international regulators, and we will share information where possible about particular safety concerns in order to strengthen that signal assessment. We seek independent advice where appropriate, we have the PRASEAG, which you are going to hear from later, which is our breast implants and cosmetic, I have just forgotten the full name, and we will also where possible seek the patient view about any particular safety issue that we have. We are very keen to reach out and discuss safety issues with patients to understand their perspective and integrate that into our benefit-risk assessments.

We are actively developing and looking to launch something called a pre-market legislation, and we hope to lay that legislation in the new year. We are also looking at implant cards. It is very important to have a breast implant that includes traceability because historically women may frequently not have known which particular breast implant they have received or which product they have had. We are also looking to ensure that when a manufacturer registers its device with us it uses something called a unique device identifier and that allows us to understand what the device is. There are something like three million devices on the market, so it is really important for us to understand which particular product a patient or healthcare professional has reported to us. So that implant card and that traceability is absolutely key and is definitely something that we need to improve on because illnesses such as BIA-ALCL have a long latency period—it can be seven to 10 years before it may emerge—so it is really important that we can associate any symptoms long into the future with the original operation. Ideally of course it would be recorded in their electronic health record and that is something that we are discussing and trying to work with the systems in order to see if that could be implemented.

That is fine for breast implants, but there is now a huge non-surgical procedure sector worth billions of pounds to the UK economy. We heard about the horrors of liquid Brazilian butt lifts; Sasha Dean, who came to give evidence, told us how she ended up with sepsis and in a coma and was given a 5% chance of survival. Thankfully, she was able to come and give us evidence. Why is it that in the UK, any one of us can buy filler and inject it into our faces, whereas in many other countries it would be illegal to do so? On the criminal enforcement side, why is it that the person who did that damage to Sasha is still able to practice on her high street in her local town? If she had done that damage to Sasha with a baseball bat, she would be in prison. Why is it that any of us can buy filler and Botox in this country?

It is important to differentiate between Botox, which is classified as a medicine, and dermal fillers. Where dermal fillers are classified as a medical device, that is the legislation they fall under. Dermal fillers can be classified as a medical device if they have a medical claim associated with them, and they would then be regulated under our regulations. I can see you smile.

That is because I do not think the regulations are particularly well-enforced or working at the moment.

If they have no medical claim—if they are aesthetic—they do not fall under the medical devices regulation and therefore do not fall under our remit. There is something called Annex XVI, which is being implemented as part of the EU MDR for a range of products which do not have a medical claim, but are similar to products which do have a medical claim. We have already consulted on bringing those under the legislation, so that is something we are actively looking at in order to help address your concern.

Would that be for all fillers and for the facial threads that Catherine mentioned? In terms of an enforcement angle, would that be helpful and useful for enforcing those rules? What do you need to better enforce these rules? It is all very well to say we are going to have breast implant cards; breast implants have been around for decades. These are all new emerging treatments or procedures. How is it that we are so slow at ensuring that there is adequate safety?

I may be able to help by adding to what Dr Cave has said. Make no mistake about it: those who are injecting people with unlicensed Botox or botulinum toxin products—sometimes counterfeit brand products and sometimes entirely unlicensed products—are criminals. Whether we like it or not, there will always be criminals at work. We are quite fortunate in this country to have a dedicated criminal enforcement unit within the MHRA, and that unit does its level best to tackle that type of offending. In relation to Botox, specifically botulinum toxin, you will be aware of the unfortunate events in the north-east of England over the last couple of weeks that we are investigating. I cannot say any more than that because we are actively investigating that case at the moment, and I am sure you will understand that it could prejudice future action and indeed prosecution if it gets to that stage; but we are tackling it. Over the last two years we have removed around 2,000 doses of illegally traded botulinum toxin product from circulation. I am not saying crime is something we cannot deal with; we do deal with it, and we have the tools we need to deal with it, but I am afraid that there will always be criminals who seek to exploit whatever regulations we put in place.

That figure of 2,000 sounds like a lot, but what is that in terms of the percentage of Botox dosages out in the high streets and in the supply chains at the moment?

That is a very good point. We do not know—we do not have a baseline to understand how big this trade is. I would put it into the context of the wider illegal trade in medicines; last year we seized around 17.5 million doses of illegally traded medicine. That suggests to me that, although it is very serious, the trade itself is relatively small.

Is the trade in Botox very small?

The illegal trade in Botox is very small in comparison to the wider illegal trade in medicines, which does not mean it is a good thing. I get that the harm is very high, and we have seen that in the last couple of weeks.

The NHS is not responsible for independent practice; we only look at NHS practice. From the point of view of registries, a lot of work has been going on. It is fair to say that we do think all implants should be registered. Registers have a number of purposes; one is documenting that someone has had an implant, which occurs anyway in notes and so on, but the central ability is to look at what has gone on and recall where necessary. It is also about follow-up and outcomes and so on. Right now, there is a significant burden to filling out that register. Clinical colleagues tell me that it is actually physically impossible to fill in all the detail between operations when you are under pressure to do a lot of procedures. There is a balance between the amount of detail requested versus compulsion; over time these will become compulsory. You have colleagues in your next panel who can probably tell you much more about filling in these things; I am not a breast surgeon, and I do not fill them in, but it is quite a burden. Partly they will be supported by electronic health records which are not yet universal. We have to improve digital capture techniques to help people in that regard and then over time, these will become compulsory. At the moment, our estimate is that 80% of implants are recorded centrally; they will all be recorded in notes locally.

The registry came in in 2016, so it was relatively new then.

We need to get to the point where everyone has electronic health records, and everything is digitised. That will make it more straightforward.

Yes.

I do not have that data.

It is very hard to give you an estimate. I gave you some figures around breast illness in the context of the number of operations that have been performed. It is really hard to get that incidence data, and I would not pretend that the numbers reported to us are an accurate record of potential incidents. We get reports about contracture and other local symptoms associated with breast implants, but to get an absolute incidence is very hard to do in any particular scenario because you need to understand the baseline, and then you need to be confident that you are getting full capture. In order to do that—

I do not know whether we have time, Chair, but we have hospital episode statistics of NHS activity related to the insertion of prostheses, which are trending downwards. In 2015-16 it was about 5,000 a year, now it is just below 3,000 a year. We know that since 2015, 25,000 procedures for the removal of breast prostheses have been carried out. It is not possible to say what proportion of those are PIP implants. There have been 3,500 revisions and 15,500 renewals, so we have episode statistic data on activity round that, but it will not say whether they have ruptured. “Rupture” is a dramatic term; they tend to leak if anything rather than explode, if you see what I mean, but we do not specifically record the reason because there are common complications around rippling, capsulation and leakage. It does not record for which reason the work is carried out.

I would just add that on our website we give quite a lot of information about the reports that we have received about BIA ALCL. As of December 2024, we have received 113 reports of this particular side effect; we report those per manufacturer and per type of breast implants. We estimate—and this is an estimation—that the latest reporting rate is about one case per 14,200 implants sold, which is not necessarily the same as the number implanted. As the registry grows and builds up, we will maybe be able to use those operation rates as our denominator, but at the moment we cannot because of the time it takes for the BIA ALCL to actually appear. We need that data back a little further. Over time we hope that that will improve.

Thank you. We have heard in other sessions and panels that data is not where it should be on this. I am going to hand over to David now.

I have just one question for Alison, but Andy, you may want to help back up on this. We have heard a little of this throughout the conversation so far, but I want to focus on regulation. It would be really helpful if you can clearly set out the MHRA responsibility regarding the regulation and surveillance of both surgical and non-surgical medical devices and products. If you can separate surgical from non-surgical that would be really helpful.

Surgical is predominantly breast implants; they are classified as a Class 3 medical device and so that falls very firmly under the legislation. They have to have a European CE mark or a CA mark in order to be placed on the UK market and have to meet standards of safety and quality in order to get that CE or CA mark. That is very clear. For dermal fillers, as I indicated, it is a more complex picture. If the dermal filler has a specific medical intended purpose, for example reconstruction as a result of trauma, it will be considered a medical device. It would also need to comply with those requirements set out either in our legislation or the EU legislation because we are still accepting the EU CE mark in order to be placed on our market. If the dermal filler makes only aesthetic claims about the product, such as wrinkle reduction, but it does not make a medical claim, in that scenario it would likely fall under the general product safety regulations and would not be regulated by the MHRA. There is another category which is quite confusing, where dermal fillers contain medicinal substances—lidocaine or another anaesthetic, for example—that are ancillary to the device. In that case the legislation it would fall under would depend upon whether it was CA or CE marked or not. If it was CA or CE marked it would fall under the medical devices legislation; if not, then it would be regulated under the HMR, the Human Medicines Regulation even if it was an unlicensed product, because in that case it might not have a medicinal authorisation for that product.

You did a brilliant job, Alison; it is quite complicated. The anomaly is the final one Dr Cave mentioned, which is where something does not have a medical purpose but contains a medicine, for example lidocaine. We would treat that as any other unlicensed medicine. We would enforce the first and the last of the four that Dr Cave listed.

I have two very quick follow-up questions. I first want to focus on surveillance because we did not talk about that in the response, but just to clarify, could a product be used for reconstruction for example, and used for aesthetics? If that is the case, are we saying that it would be regulated when a medical professional is using it for reconstruction, but the same filler would not be regulated if somebody was using it purely for aesthetics?

If it is a medical device and classified as a medical device, we would still regulate it as such.

Even if it is just being used for aesthetics?

Yes.

It is important to stress that this is about the product, not the administration of it or the clinical aspects of it, but just the product itself. The product remains the same irrespective of its use.

Can you tell us about your surveillance procedures?

As I have indicated, there are three main areas. We have the yellow card scheme, under which patients and healthcare professionals report to us, but if it is a medical device—and that is key—the manufacturer also has obligations to look after the safety of its product on the market and to report to us if it receives reports. As I have indicated, with the new legislation the manufacturers now have enhanced responsibilities; they must report any suspected serious reaction to us within a set time frame, have a post-market surveillance plan, and give us periodic safety update reports which should include trends. They have responsibilities to report to us if there are incidents which occur globally, even if those are not within our territory. So there are now a number of enhanced regulatory requirements on the manufacturer. We are also constantly looking at the literature to understand if there is anything emerging that we should be looking at. Along with all medicines and medical devices, we also have a network of medical devices safety officers and yellow card networks which are trying to look locally. So there are a number of ways in which we try to capture safety signals.

It is not that difficult, and it is not that complicated; we all understand that. I want to ask how we stop people using something for aesthetic uses that has very dangerous health consequences, such as the liquid BBL. What needs to change in the law to stop untrained people getting their hands on filler that currently falls out of your remit because it is just for an aesthetic purpose? How do we stop that?

Unfortunately, that falls outside the NHS framework.

So how do we stop that? Do we have to recommend that there need to be changes to the law to ensure that filler for aesthetic purposes falls under your remit? Do we need to do that in order to stop unlicensed, unregulated people getting their hands on filler that is just for an aesthetic purpose and injecting it anywhere into someone’s body? That probably falls to you as the NHS; what would be helpful to you?

The NHS deals with the complications of that and is concerned about it. We recognise that the Government are consulting on regulation around this and we are very supportive of them doing that; we recognise their concerns and share them.

Have you ever worked out how much it costs the NHS to rectify this?

No, we have discussed this, but it is very difficult to do because people will record a complication and an episode, but they will not necessarily say where it occurred. As it happens, my wife is a breast surgeon, and she would say that on a weekly basis she sees people with complications from surgery abroad coming in and requiring supportive treatment, but that is not specifically recorded. There is an ongoing discussion on whether it should be recorded, but of course it then comes down to how we get that money back. That is very difficult because we exist to support people who are suffering and to give them care. It is a very complex business to then turn to them and say, “Actually, now you have to pay for it.” There is a complicated landscape around insurance and so on.

This industry is worth billions, and it is in every high street. Every hairdressers or nail salon will offer Botox or fillers for aesthetic purposes, but you are saying that the things they are injecting do not have to meet any of the regulations because they are not being used for a medical purpose. If there is an appetite for that, please say now.

That is the Annex XVI that we are talking about, which we consulted on and are currently considering. It is in the EU MDR. That would at least bring some of these products under a regulation. I would emphasise that that does not then necessarily regulate who administers them, and that is what you are alluding to. The Government consulted on that particular issue a couple of years ago and we will shortly respond to that consultation which may be a way forward.

You can see how much more widespread and normalised this has become in those two years. We heard about the psychological impacts, the mental health impacts, and the fact that advertisements are almost 24/7. Young girls are particularly targeted with advertising on social media for cosmetic enhancements with things such as lunchtime boob jobs, for example. There is a real slowness from the agencies that should be protecting people and making people aware of the consequences of this, and the NHS is taking the impact of it.

Following on from that, we heard evidence that there is widespread administration of Botox without prescription. What is the MHRA doing to combat this?

That is probably one for me. It is important to distinguish between Botox and fillers because Botox is to some extent a slam dunk under the regulatory perspective. As I have already said, there is an illegal trade, and it would be very difficult to put a number on how big or how prevalent it is, but I do not think it is quite as big as one might think. With all our enforcement of medicines regulations, we take a multi-dimensional approach. We go out and arrest people and prosecute people. As I said earlier, they are criminals and should be treated like criminals. But there is another way, which is about behaviour change. You can never really arrest your way out of any crime problem—and what you describe is a crime problem—so it is about a multi-dimensional approach. We try to do preventative activity. I am speaking at a cosmetics conference in a couple of months’ time to discuss this with practitioners because I firmly believe that there are a number of practitioners who just do not know that what they are doing is illegal. Their behaviour can be changed. It is about changing the behaviour of the offender but also changing the behaviour of the customer. We do a lot of proactive communications activity in the national media to try to bring the risk to the attention of the people availing themselves of this illegal trade. It is difficult to measure our success, but the fact that we have kept the illegal trade in these products to a reasonably small size is perhaps validation of that. There is always more to be done and with a dedicated unit within the MHRA, my officers are out there day in day out tackling this offending.

A very quick follow-on from that question: you said you do not think this is widespread. Do we really understand how big a problem this is? Our evidence would suggest that it is a bigger problem than perhaps we might think.

Any crime is difficult to measure to any degree of certainty, because it is a hidden thing. Crimes are not done in plain sight most of the time. We work on intelligence, gathering it from multiple different sources to come to these conclusions, so while I have not put a size on whether it is growing or reducing—I would not be able to do that because without a baseline it would be meaningless—what I am saying is that, based on our current intelligence picture, it is not as significant as some other areas of the illegal trade in medicines. That does not mean to say we are not giving it attention, because we are.

Thanks very much for coming in today. Moving on to public awareness and education, as a mother to a 17-year-old daughter, this stuff quite frankly scares the life out of me. A survey was carried out in 2024 with Girlguiding UK which polled 2,734 girls and young women and found that “Just over a quarter of girls aged between 11 and 16 said they would contemplate cosmetic alterations to their appearance” at some point in the next two decades. Fast forward to between the ages of 17 and 21, and that figure rose to almost half of the girls polled. It is a challenge that social media plays a constant presence in our young people’s lives. Obviously, you will have little influence over that, but when it comes to public awareness, is there is a role for educating children in school? Who should be doing that? Talking about social media, is there a place—maybe you are doing it already—for the NHS to have an education strand pushing out “Here are the harms?” The fact that this is becoming so normal is horrifying; we need public awareness and education through school or social media. What do we do?

As you say, it is a difficult issue, and it is difficult to control social media. We have some guidance, for example, “Is a procedure right for me under the NHS?” and “Choosing who will do your cosmetic procedure if you are going to go ahead.” A decision around education in schools would generally be a matter jointly between the Department of Health and Social Care and the Department for Education to decide. We work in schools and I am sure we would support that if asked to. It is also important to point out that we are expanding mental health support in schools, particularly for those at the more extreme end who have mental health problems as a result of anxiety related to body image. In the 10-year plan, about 1 million more people are set to benefit from that. There is ongoing work to try to increase that support in schools.

Thank you, Aidan. If you do not have the figures with you now, it would be really useful for the Committee to know how well used that tool is and whether there is more that can be done.

I do not have it to hand, but I am sure we can look at how many hits those sites get.

It is really important, because I know that you are fighting an uphill battle in terms of targeted advertising on social media and the power they have compared to the NHS. Perhaps more could be done by social media providers to promote the work that you have offered.

I have one extra point to make. With social media, I appreciate that it is about influencing youngsters to a new norm for behaviour, but where social media is being used to sell and promote these products rather than just promote the lifestyle that goes with it, we take action with social media companies to remove those posts and to remove the sale of those products. We have great co-operation from the majority of social media companies. It is not that we are doing nothing, but I accept that there is always more that can be done in that space and as a father of two 15-year-old girls, I share your concerns.

We have heard a lot in this inquiry about the growth in cosmetic surgery tourism—beauty tourism as it has been called—and the problems that is bringing. Professor Fowler, you alluded to it earlier; can you give us an idea of how many complications from cosmetic procedures carried out both domestically and abroad have been treated by the NHS? Abroad is quite important.

It is really difficult to know. We know that it is increasing, and we know that the numbers are pretty significant. An estimated 431,000 UK residents travelled abroad for medical—not just cosmetic—treatment in 2023. We know that once people travel outside our borders and into unregulated territory, there is a higher risk, but we do not have a mechanism for knowing how many of those people re-present in this country. We can give anecdotes; we know there are some very worrying cases of people who have returned both from cosmetic surgery and, for example, bariatric surgery, but it is really hard to put a figure on that. It is a matter of active discussion. The Royal College of Surgeons has been discussing this, and certainly the Department of Health and Social Care is very concerned about it. Various approaches have been taken to try to manage this. Some professional groups support improving training abroad because if people are determined to go, at least we can try to reduce the rate of complications. So a number of things have been done. I am not here to talk about regulation, but clearly that is being consulted on. We recognise that the Government are rightly concerned about this and are looking at regulation. We also recognise that they will be concerned about increased regulation here driving people abroad or into the hands of criminals, so we have to think very carefully about balancing that risk.

Do you have any data that shows the trend in people going abroad?

We have seen an increasing trend, but I do not have figures over time other than that it was said to have doubled between 2017 and 2019. I also have an estimated figure for the number of people who travel abroad. The number of people travelling in 2023 was, as I say, 431,000, which as you will recognise is a staggering figure.

Do you have any clear estimate of the financial burden placed on the NHS by corrective treatments?

Unfortunately, we do not. As I say, people are recorded as having the complications of surgery, but we are not recording the origin of that surgery and where it was carried out, so it is difficult at the moment to tell between surgery carried out here and abroad.

Do you think you need some mechanism for that? It baffles me.

Again, it is about the burden of data. It would be for the Department of Health and Social Care to decide whether to collect that data, and if we do collect it, what we should do with it. It would give us an idea of what is going on, but it would not necessarily give us the ability to reclaim that funding.

I have one last question. It is about the consultation that you talked about with the MHRA, and the ongoing work around getting data, particularly on breast implant safety. I wondered whether you were in touch or perhaps looking to reach out to professors working in this area who have concerns. We have heard from Professor Michael Coleman, professor of toxicology at Aston University, and Professor Prabath Nanayakkara, professor of acute internal medicine at Amsterdam University Medical Centre, who both had serious concerns around research data and breast implant illness. Are you actively seeking professional advice and input from people who have concerns on breast implant safety?

We seek independent advice through our expert committees, and you will hear from the chair of that committee in your next session.

So that is a no.

I am very happy to reach out to Professor Coleman and your other witnesses to discuss their concerns and to look at any data they may have. We are always open to receiving more information to support our safety assessments.

That would be great because their evidence to the Committee back in May was shocking to us all. Many of us assume that breast implants are part of everyday culture and everyday life, but actually the concern was around the data that as has been outlined is not being collected from the NHS. The yellow card system, or the self-reporting system, only work where there are symptoms, which means that women are less likely to be taken seriously. We have already heard how hard it is for a woman to be taken seriously when they have not had cosmetic surgery and when they have had cosmetic surgery it is even harder, so it would be great to have another side to the argument. Thank you very much, and we look forward to receiving your written evidence. We will move on to our next panel. Witnesses: Elaine Sassoon, Nora Nugent, Professor David Sines and Rieka Taghizadeh.

I am really grateful that we have a fantastic, excellent and new panel. We have Nora Nugent, cosmetic surgeon and president of the British Association of Aesthetic Plastic Surgeons; Elaine Sassoon, plastic surgeon and board member at the British Association of Aesthetic Plastic Surgeons; Rieka Taghizadeh, consultant plastic reconstructive and aesthetic surgeon—that is a lot—and chair of the British Association of Plastic Reconstructive and Aesthetic Surgeons breast special interest and advisory group—that is even more of a mouthful, but thank you very much for being here; and Professor David Sines, executive chair and registrar at the Joint Council for Cosmetic Practitioners. Thank you and welcome to you all. I am sorry we are running a little behind, but I will quickly pass over to Rachel.

Thank you for joining us this afternoon, and apologies that you have had a bit of a wait. This is a very broad opening question so, Nora, I am going to ask you first: what is your assessment of the safety of breast implants?

They are safe devices in the majority of women but, as with any procedure, implants come with benefits, risks, and long-term considerations. It is about a very detailed consultation beforehand so the patient can weigh up the benefits and the risks versus the long-term implications of having an implant, and just knowing that things evolve over time. For example, we have had a lot of discussion about BIA-ALCL. Some 30 years ago that was not in the equation, so it is just realising the implications of having an implant. We heard a lot about the negatives in the last session. Implants have brought enormous benefits for reconstructive purposes, congenital anomalies and so on, so it is getting the full picture and giving a patient time to decide and make a proper decision.

Rieka, would you agree with that, or is there anything you would add?

First, it is a pleasure to be here. You are the first person who has actually pronounced my name properly, so thank you very much. I agree with Nora. I am very grateful to be putting my reconstructive, corrective and aesthetic hat on. As Nora says, breast implants have played a crucial role in all these areas of practice. Everything evolves with time. The implants we had six generations ago were very different to the PIP scandal and to where we are now in 2025 where they are still part of a very serious armamentarium of what we offer patients. However, as with any medical device, we have to be aware of the limitations and select the patients appropriately for who we are using it for, and it is all about informed consent. Finally, it is about the expertise combined with the use of an implant to offer the best solution for patients.

What protocols are in place to ensure that patients are fully informed of the risks, particularly the long-term risks around cancer and breast implant illness?

I am going to clarify our titles a little because one of the issues on the cosmetic side is the misuse of titles. All three of us here are plastic surgeons. The title “cosmetic surgeon” is very misused in the UK. Coming back to the protocols: if current advice or good practice is followed there is actually quite a good process in place. It is ensuring that it is followed and that the properly qualified people are undertaking the procedure. I am focusing more on the aesthetic end but it obviously overlaps with the reconstructive side as well. The current advice is to have two consultations before undertaking any procedure of this nature, and a cooling-off period of at least two weeks before undertaking the procedure, so not seeing someone and rushing them in straightaway. These can all be longer than the minimum requirements, but that is the minimum good practice advice and procedures that are in place. It is about viewing consent as a process, starting from the moment you have the first discussion with the patient, following up with written information, giving them a chance to come back with questions and then, finally, going through a consent form ahead of surgery so that by the time the day of surgery comes around you are just confirming things and answering any last-minute questions rather than piling new information on to the patient.

Is there sufficient evidence of the risks to enable patients to make informed decisions?

Yes. It is about presenting the evidence clearly and, I guess, caveating the current evidence with the knowledge that things may change in the future, but there is actually a wealth of data about breast implants generally. There are a lot of new studies on breast implant illness looking at the serological, histological and symptomatic implications of removing or not removing capsules and so on; informing patients of the risk of BIA-ALCL; putting that in the context of the more usual surgical complications such as infection and so on; and really weighing that up against the benefit of the implants. In the first place, we are placing those implants for a reason and it is not always a trivial reason as is widely reported. These implants often make a huge difference to women in a positive way, but it is balancing information and risk against the benefit and giving the patient the chance to make the right decision.

What proportion of patients have adverse reactions to breast implants?

There is a very distinct difference between the category of reconstructive patients who are coming with a cancer-related need for reconstruction versus those who are opting to have cosmetic enhancement. In that caveat, I also deal with a lot of paediatric referrals, so people who have been born with congenital anomalies and have quite significant asymmetries or deformities of their chest wall. As Nora mentioned, the use of the implants is quite widespread and it is really important to understand what context you are using these implants for. There is a distinct difference. Elaine, do you wish to add to that?

Nora will take that.

There are studies looking at specific implants and specific complications, but one of the key things to understand about implants is they are long-term devices, not lifelong devices. If you place an implant in most women at the age we normally place them, they should be informed that a second surgery is on the cards at some point in the future. There is a difference between a complication that happens, say, a year or two out from surgery and something that happens due to maybe changes at the end of the lifespan of the device. They both need treatment, and the patient needs to know about both of them. One can be indicative of a fault in the surgery or the implant whereas the other can be indicative of the end of the lifespan. There are studies looking at, for example, rupture rates and capsular contracture rates. With an implant, it is important to get long-term data. It is interesting to get one and three-year datasets on implants; that gives you an idea if there is something really going wrong or if particular complication rates are wrong. However, we also need the durability data which is at least 10 years, so it is following things in the long term. That is where things like implant registries reporting adverse events and post-marketing surveillance come in. It is very hard to give you precise figures for the overall picture because there are different categories of complication and different timelines.

Within that first category—the one and three-year data—what sorts of incidence of adverse reactions are we looking at? What sort of percentages?

We would expect very low risks for something like capsular contracture where the capsule that forms is thickened and hard. Studies vary, so I am giving a middle figure. Figures of about 8% have been reported at 10 years and 12% at 15 years. You would want one and three-year figures much lower than that to be indicative of a good device. If the figures are good in the early stages that is good, but you would still want the later data. If the figures are bad in the early stages that is an indicator of a problem.

There seems to be a number of different studies out there, but what role can all your organisations play in collecting and publishing better data to enable those informed decisions?

I am here representing BAAPS, and I represent BAAPS on PRASEAG, the advisory committee to the MHRA. First, to ensure our members meet the standards that we would want implemented for patients. Secondly, to provide good quality patient information, and we have detailed information leaflets available. Thirdly, to follow the good practice advice that is actually already there. It can work quite well if it is implemented. Also, to provide education from a patient perspective. Our primary role really is to educate and try to improve the quality of aesthetic procedures across the arena in general. That falls on both educating patients or potential patients, and educating plastic surgeons and our members to make them aware of what is going on that maybe does not meet the standards that we would like, so knowing the arena as well.

Education is absolutely key. Educating the surgeons of the current generation and the generations to come about safe surgical practice is absolutely paramount through training throughout their specialist training, and even continuing for many years after. Educating the patients is multifactorial, so we just need to be constantly up-to-date with what possible risks are emerging from devices. It is all about evolution and constant quality control, not just of your surgical practice but of everything that goes on in that environment.

There is an aspect which we have not discussed which putting an implant on the market does not cover, and that is our selection of patients. It is not just psychological; it is also physical. It is also deciding whether to put an implant in somebody who smokes because that really increases the chance of adverse problems. We are not talking about the BIA-ALCL; we are talking of developing a capsular contracture which can be a painful thickening around the implant which means you then want to remove the implant and change it, and that is an extra operation. Another aspect is educating our members—which we do constantly through a forum and through meetings—about risks, personal experiences and discussing problems so that we are alert to problems and are not being caught unawares. We are talking of it as a procedure. We are putting something in a body, but the body is dynamic and people have different health problems and react differently. Somebody might have a more active immune system than another person and may react more, or they may have rheumatoid arthritis. Also, with age, your immune system is different and you will react differently to an implant. This is where some of the research also falls because research traditionally has not covered women—although these implants go in women—and people over the age of 60. It is an interactive process, not a one-off.

My focus is very much on the non-surgical compliance, but certainly we all have a responsibility to report. I guess we will say from the outset that the JCCP not only works really closely with my colleagues in BAPRAS and BAAPS but with the British Association of Dermatologists, which is really important. We have a memorandum of understanding with the MHRA, so we may want to draw a number of additional points through the conversation on that later on, but certainly reporting is very significant. With breast implants, it is probably a much higher rate of reporting; definitely not so when it comes to the non-surgical or the dermal filler issues.

We have heard a lot of evidence about PIP implants, and you mentioned them earlier. You have covered a lot about the protocols and so on, but with regard to them specifically, what lessons have been learned from the PIP scandal? How have these specifically influenced current clinical standards?

The one thing they have led to is the re-implementation of the breast implant registry to track situations such as this. There was a previous breast implant registry that predated the current one but it was held in a particular hospital. Elaine will know the details of it better than me, but it was voluntary and when funding ran out for it, it stopped and so we had gap years with no registry. The current registry has been up and running since 2016. We have heard about the difficulty in getting data out of it, but I would say please give it a chance as well because implant data is the long game, not the short game, and it has not even been running for 10 years yet. It is actually actively working and in the future there will be more useful information. That is one significant change. I guess the problem with the PIP issue was that medical-grade silicone was not used so it did not adhere to the standard to which it had been granted certification as such, so it is about looking at how future standards can actually be implemented and monitored. That also comes down to post-marketing surveillance. It is fair to say there are many lessons out of the PIP problem, some of which are still ongoing or not fully implemented. I would not want to call it a valuable experience because it has not been from a patient perspective, but it has brought some things back into focus with a view to the future.

It is worth knowing how a medical device comes on to the market. A manufacturer produces the medical device and then it needs to be approved, so it goes to what is called a notified body, now called an approved body. Pre-Brexit—because politics come into it and is very important—every country had a number of notified bodies—there were about 80—and they were variable in quality. The PIP implant was approved by TÜV Rheinland, which was supposedly a good notified body, but it should not have been in terms of it does biological, chemical and physical tests to see whether things are strong enough, fulfil the data on safety, and are appropriate for the intended use. Whether they are appropriate depends on papers that are written. A new device will not have any papers written, so it will go on equivalence to something else or obtain data once it is on the market, which is what was happening in Europe. TÜV Rheinland was the notified body for PIP implants and it should have picked up that they were more fragile than other implants, and it did not. So, it went on the market and was picked up later by the French equivalent of the MHRA. In the meantime, Jean-Claude Mas, the founder and CEO of PIP, who had no training—he was the son of a butcher, not that that was a problem—set up this company. Surgical-grade silicone was very expensive; there were only a couple of providers. He started to use cheaper industrial-grade implants—not for all implants, and more in certain countries—which muddied the waters. The American FDA, which was much tighter, did not approve those implants and it did not approve implants unless they had been on the market for nine years or so. The manufacturers would put them on the market in Europe and then, when they had enough data, they would go to the FDA. The FDA picked up on some saline implants that same company was making and found that they were defective. There is a question as to whether it told the French equivalent of the MHRA or not, but they never went to America. So a combination of factors came into play. A manufacturer then gets approval. If this notified body says the product is good, the MHRA uses that data to move forward. To actually put a product on the market costs a lot of money. For a new product you are talking £400,000 or so because it takes six months to a year and so on. All these factors come in. Together with the European Medicines Agency, we came up with the Keogh report and so on and said, “Let’s make things tighter.” That included tightening up the notified bodies and included the post-market surveillance whereas before all you needed to do was to let the MHRA, or sometimes the implant company, know if there was a problem, but sometimes they could get lost or whatever. With this, it tightens up the requirement on the medical producer and includes surveillance, so there is a responsibility on the makers. Annex XVI, which Alison Cave mentioned briefly, was for products without a medical purpose. Brexit came in and then all the work we had done with the European Medicines Agency went by the by. We lost the money that the EU was giving to the MHRA, 25% of often senior MHRA staff quit or were helped to leave, and it is now rebuilding itself. This is the background to this, and it is a catch-up. Q169 Christine Jardine: Should women who still have PIP implants have them removed?

I say yes. I was involved at the time. I worked in Norfolk and none of us put in the PIP implants; we just met and said no. However, our switchboard, both privately and NHS, was swamped with terrified patients. You would give them a card; they forget; they move house. They cannot even remember who you are anyway a year or two later. We immediately put out messages and we set up a webinar for concerned patients to answer the questions and tell them that nobody in Norfolk had PIP implants. That does not mean we did not see them come in, and we found that in certain parts of the country there were foci where these were put in. The British conclusion was that they did not need to be removed, but the French did. I was brought up in France; I know how they think. We think the reason was resources and it was discussed openly in the Royal College of Surgeons and BAPRAS. The NHS was being swamped, not because they had put them in, but the idea was that they would be removed on the NHS, whereas the French system is different and there was extra capacity. You cannot divorce the clinical from the actual sociological.

I would also point out that PIPs were withdrawn in 2010. That means any PIP implant in situ is at least 15 years old, and that is near the end of the natural lifespan of any breast implant. We would normally advise patients to have implants checked regardless of the type of implant; I am not specifically talking about PIPs in this point. It does not mean everyone needs an operation just because their implant is 10 or 15 years old, but they are due a check because that is still the average lifespan of an implant. If PIPs were withdrawn in 2010, and we are now in 2025, those implants are at least 15 years old, maybe older.

Which is another problem.

The US FDA recommends an MRI scan five years after implantation.

It is changing those slightly. The recommendation for a check and a scan is still the same, but it may change from MRI to ultrasound.

Is that the same for the UK, or not?

In principle, yes, but in reality it is very difficult to have patients come back, and it is also additional cost for patients. MRI and ultrasound scans are not cheap and, remember, most of this is in the private sector so it is an additional cost to the patient on top of their original surgery cost. I discuss it with all my patients when we are effectively at the surgery endpoint, but they are not at their implant endpoint. In reality, it is quite a difficult follow-up to impose on patients, but those are the recommendations.

It is about £800 for an MRI.

Rieka, do you agree with all that? Do you have anything to add?

Yes, I agree. From both an NHS and a self-pay perspective, PIP implants should be removed. I hold quite regular meetings with representatives from all over the country who do breast practices and, having done one recently, everyone is of the same opinion that actually in the UK if someone comes in with a PIP implant on the NHS, we would remove them. But replacing is a completely different concept; I think we can come to that later.

One final thing is that we are not just talking about toxicity. We know there is what is called implant bleed where silicone seeps out even when an implant does not look ruptured. The silicone will go to the lymph nodes. Most of the time there is no problem, but sometimes they cause pain or other symptoms and you might remove the lymph node. However, the anatomy varies and some people, if you remove the lymph node, will get lymphedema so we need to look at the big picture.

It is back to risks and benefits and properly informing the patient.

Thank you. That is something we have heard through every session around this idea of properly informing and then what informed consent really looks like, not necessarily with surgical procedures but with non-surgical procedures especially.

Nora, should cosmetic surgery be a recognised specialty within medicine with regulated training and title use and, if so, why?

Actually, I believe it should stay part of the specialities that currently undertake it, but with proper recognition for training. I know you had Professor Vivien Lees in an earlier session talking about board certification as an additional kitemark. To be perfectly honest, we are a very tightly-regulated country in some aspects, but in aesthetics generally there is this whole blind spot of who is doing what. The priority for me would not be recognising cosmetic surgery as a specialty; it would be tightening up on who is doing what in the current situation. That is far more imperative, whether it is surgical or non-surgical aesthetics. I am skipping a little from implants, but we have the ridiculous situation where anyone can inject dermal filler and it is not illegal. We have had a death from it in the last year and so, for me, as a priority, it is implementing proper training for the surgeons who have it as part of their scope of practice, but we are a long way off that being the actual priority. For me, it is more about regulating all the unregulated people who are doing this sort of work, and I am not just talking about breast implants, but generally in aesthetics.

David, could I just come in at that very point as that is a very helpful segue? I am sure you will appreciate that the definition of cosmetic surgery has been somewhat vague, but we are closing that loop. I know you have heard evidence from Vivien Lees from the Royal College of Surgeons. We have worked incredibly closely together with the Royal College of Surgeons and I believe significant success has been achieved in the last 10 months over the Brazilian butt lift treatments, the augmentation of genitalia, including breasts of course. Hair restoration surgery comes into this somewhere as well. These were incredibly loose concepts that were under the umbrella of non-surgical. I do not want to get into all the detail, Chair, but we have now come to a point of understanding and recognition that these procedures should be regarded as cosmetic surgical procedures in their own right. It is a huge step forward. Why? First, it is going to make a significant difference when the Government make their determination on regulation of the non-surgical cosmetic sector. They will determine who might regulate part of that sector by identifying procedures that are incredibly high risk such as the BBLs, breast and buttock augmentation, and liposuction which are all in this particular bundle. I believe there is a very high probability, Chair, that those procedures we recognise now as surgical will therefore come under CQC oversight. Now, a quick diversion: I will be brief because it is not within the purview of this Committee, but the Scottish Government have now released their proposals. I am delighted with those proposals. They bring these procedures under the purview of Health Improvement Scotland. They restrict who can actually provide those procedures, and this is the point I think Laura was making. At the moment, anyone can provide those procedures on the high street. I am talking about the enormous challenge of BBLs. We know of fatalities. We understand that, and it is a very important point, and I am confident that your Government will bring proposals forward. We await those proposals, Chair, where we will see that there will be a restriction on who can perform them. That is a question that links to your point. The who, in terms of the procedures I have just mentioned, should be restricted to GMC-registered doctors. I am not talking about physician associates; I am talking about doctors. Then you have the point: should they be surgeons? I am not going to present a view on that because I know the view of the Royal College of Surgeons. I also know the importance of the specialist registers that we are in fact making reference to here in plastic surgery for example, but it is critically important that we restrict who performs these procedures. I am talking about the BBLs, liposuction and so on. Of course, you have been referring to PIP implants, but there is actually no difference when you come to some of the severity of what is happening here. However, the other point is about the devices themselves. We have heard from MHRA. I will straightaway take the view that all devices that are actually inserted into the body, particularly dermal fillers, should be regulated. I take that as a long-standing challenge, one I know my colleagues support completely and, of course, it is a differentiation between cosmetic use or medical use, but that is not of interest to me to be quite honest. I am not trying to subjugate that, but it is important. If you are inserting a filler into someone’s body, we know the level of complication is significant, which is my next quick point. We also expect the Westminster Government—I use that term because we work across four countries—will be bringing forward the same proposals I mentioned to review the botulinum toxin and the dermal filler issue. I am sure they will not say—says David with confidence—that fillers should be regulated by MHRA, but that does not mean to say we do not believe that they should be. I will just mention one final thing if I may, Chair, because it is such an important point. The volume of filler, the type of filler, and the way in which the products are coming into the country is, of course, a challenge. I recognise a counterfeit fraudulent product, but I have to remind us that we have been talking today about botulinum toxin as well. We have heard the case. I am sure colleagues will be aware of the 28 cases in Durham in the last four weeks where there has literally been botulism toxicity and, of course, there was no actual product available because one does not expect it to be kept in an A&E department. Admittedly, my comment to MHRA was, “We are investigating that,” and of course that is right.

We need to be careful that we are not predetermining any kind of investigation.

I am genuinely not wishing to, but my point is that the actual clinic that provided that is a clinic that we would say, “Well, we should be looking at how regulation might actually be provided to all clinics.” For the avoidance of doubt, I am not singling out any one clinic at all, Chair, but we need regulation of safe product, safe medicine, safe practitioner, a training standard, and safe premises.

I just want to clarify: you said that things like Brazilian butt lifts and liposuction should be carried out by a doctor. Are you saying the same for fillers and Botox?

No, I am not. I am absolutely making a very clear distinction. We would all agree that BBLs, liposuction and so on are medical procedures and they should be carried out by registered medical practitioners.

I would like to make a point. When we are looking at regulation and legislation, please do not just look at the purpose of the procedure. Look at the level of invasiveness, product regimes, the potential complications and the skill needed to perform it, not whether it is just aesthetic or not because actually that is irrelevant from a risk profile. It is the level of skill needed to perform the procedure, the level of invasiveness, the recovery, and the potential risks. That is what should determine who is doing it, not the purpose as such. That is a really important point.

Nora makes a very important point. We are looking at a proportionate response to risk identification and I believe both the Scottish and the Westminster Governments are applying that graduation of risk.

David, if you could answer this question briefly: what should be the minimum training and education required to perform non-surgical cosmetic procedures?

Thank you; a very important question. I chaired the Health Education England work on behalf of the then Department of Health on setting those standards with colleagues. There is actually a graduated approach to this. We have some very straightforward procedures taking place in the high street such as microneedling and so on, right through to hair restoration transplants, for example. You have to look at this continuum of risk. The minimum standard of training should be a standard that has been formally identified across the four countries of the United Kingdom at an agreed standard of competence, knowledge and, actually, behavioural input in terms of attitude because it is a professional standard, and that is something we firmly believe in. It is important to note, Chair, that it would be absolutely unacceptable to restrict access to training just to clinicians for some of those procedures. We are very clear that there should be a standard of education and training determined as part of the Government’s proposed new regulation. We know that Scotland is proposing to do that. I have every reason to think Westminster will say the same, but we have to determine that standard, and that standard would need to be proportionate to the risk of the treatment that is being provided. We have already agreed that procedures such as BBLs and so on should be restricted to doctors, but they are already qualified practitioners. They have gone through an undergraduate professional training. When you move to the injectable toxins and the fillers, we firmly believe that there has to be a strong, firm standard. However, there is no reason why apprenticeships cannot be used to develop beauty therapists and others to that standard as long as they work under the supervision of a regulated healthcare practitioner, but a minimum standard is what needs to be prescribed.

That is interesting. David, should there be a licensing scheme for non-surgical cosmetic procedures in England?

Yes, 100%.

What would it look like, and would it differ between lower and higher-risk procedures?

It would. Again, the JCCP has been very clear in its campaign for this matter and has worked very closely with colleagues in both Houses on this, and with colleagues in Scotland. We are saying that where you come to the point of those procedures that are really high risk—the BBLs, ablative lasers, carbon dioxide lasers, vitamin infusions, PRP—these are all in this very high-risk category. It is not just about surgery. With respect to my colleagues, I am sure they would agree because the techniques actually using blood products and so on should all be restricted in my opinion to the CQC with regard to regulation—not licensed, but CQC regulated—and should all be subject to restriction to appropriately-trained healthcare practitioners. When you get to the point of the injectable toxins and fillers, then we come to a potential licensing model, certainly for procedures such as microneedling. However, that is a differentiation of local authority licensing. The most important point is one common standard of education and training across all. By the way, Chair, may I put in very quickly that we need to be very aware of the UK internal market issue because we are looking for one standard across the four UK countries? Anything less than that would be totally unacceptable and would be a failure in patient safety and public protection.

I understand that, thank you.

I am very conscious of time so a final question for you, David, because we still have a number of others for everybody else: how might stricter training and licensing schemes affect the cost and availability of non-surgical cosmetic procedures?

There is absolutely no question but that training costs money. We have to accept that, but I think the market itself will start to drive this in the right direction. My most important point in terms of this Committee focusing on women and equality of course, is that the majority of our practitioners are women. Many of those women are actually beauty therapists, and they will need to attain additional training should a mandated statutory scheme of licensing come on board. By the way, I do not believe there should be a restriction on who can access the training for those procedures that are non-medical, non-high risk, those we call red procedures if I might make it quite simple. Amber and green relate to Botox and so on. We must have equality of access to people to train. However, if you are going to provide invasive procedures of this nature then I believe very firmly that patient safety and public protection outweigh any particular cost, but we must provide access to persons who are functioning across the sector. That is why the apprenticeship route can be incredibly useful, even using the apprenticeship levy through FE colleges and through beauticians. It will be a new progression. There will be an additional cost, however, I would expect the market to balance the cost to the patient or the member of the public because market forces will do that.

Thank you very much, David. That is something that we have heard from other campaigners like the Save Face campaign: it is the professionalisation of this. Actually, there are some people who really want to do very well on this and want to get it right. They do not benefit from the absolute cowboys and sharks that are out there just injecting willy-nilly. That is not a word I expected to say in the Committee, sorry. We are going to move on to the really important point around mental health and patient screening.

Frankly, the cooling-off period should be applied to any procedure because you are doing an invasive procedure on someone which irreversibly changes a part of their anatomy and life. I believe that in the reconstructive setting we give plenty of time for patients to absorb information. Often, they come with the premise of seeing breast reconstruction nurses; they see us as clinicians. It is a very continuous process of understanding so that by the time, as Nora mentioned, people come to surgery they have had a very long-standing process of understanding what they are having done. In the cosmetic or non-reconstructive setting, the same applies. I believe you have to have two consultations as a minimum and some people might need even more time, so that concept of pressurising someone to have what is effectively an elective procedure should be nothing really. In terms of psychological assessment, I would hope we as clinicians have an innate ability to understand patients. If there are red flags or incidents where we do not find that the patient is on board with us or they are not on the same wavelength, you must not operate on those patients. Some people might need more time or more input, in which case I do not believe the psychological assessment applies to everybody because you can have a lady come in for a breast reduction procedure who is having significant problems of back and neck pain. That does not mean that she is psychologically unstable. As long as you have given them enough time and information, I do not believe certain procedures will require that but, again, age groups are different. You might have a procedure applied to a 21-year-old who might need a lot more hand-holding input. Patient selectivity and our understanding of needs come hand-in-hand. I hope that answers your question, but a cooling-off period 100% has to apply, a minimum of two weeks between each consultation, if not longer.

We all recommend it.

It is recommended; it is not mandatory.

It is in all our codes of practice for non-surgical as much as for surgical.

Yes, please.

If I may just add that certain hospitals will actually refuse to put anyone on a surgical list if they have not had a two-week cooling-off period anyway, so that is integrated into pathways in some hospitals as far as I am aware.

No, actually it is in private practice as well.

I am very happy about that.

If they have not had the cooling-off period they will not go ahead with any surgery.

I am sure they are. In the first place, we are referring to non-surgical procedures. That is where Save Face’s data came from. The under-18 legislation makes it clear the onus of responsibility is on the actual provider to seek proof of age. It is actually a criminal activity to not seek evidence of a person’s age in the sense that if it was found after the event to have been fallacious.

They are not on any register.

They are not on the register, or we do not believe they are, Nora.

No.

To be fair I am going to be very careful on this because we get into a differentiation of beauty therapists versus regulated healthcare practitioners. If you do not mind, it is probably better to say that in an unregulated market there is no actual responsibility in law on this, as far as we can tell. The point is: how can you strike somebody off if they are not a registered practitioner, and that is what Nora is referring to.

We heard from Sasha about the horrendous treatment that she ended up with from her liquid Brazilian butt lift, and that person is still working on the high street.

That is where the licensing scheme would transform things if it was properly implemented. I am not saying every problem is related to an unregulated practitioner, but there is more of a consequence for a regulated practitioner. Also, you keep track: you know how many are out there; you know where they are practising. It is freely available online that I am registered with the GMC, but how do you know who the unregulated practitioners are? How do you know how many there are? How do you know where they are? What do you do if there is a problem? There is no recourse. Every procedure has some risks regardless of who carries it out. You would like to hope that the more qualified the practitioner the lower the risk, and the more medical the environment the better able they are to cope with a complication should it happen. But there is also a consequence for a medical practitioner, nurse or dentist if they essentially have performed negligently or there is professional misconduct. We can be struck off. We have to have insurance. If you are not on any register and have no regulatory oversight, who do you go to? There is nobody.

I agree with everything Nora said. Thank you.

At times, we have resorted to environmental health officers helping because the problems literally fall under no other category. They are not in a CQC premises; they are not a doctor, dentist or nurse. It is an environmental health problem because it is nobody else’s problem.

We have over 400 environmental health officers who have shown interest in accepting the advice from my colleagues to my right on that very point of determining who should be an appropriate professional for those procedures.

Nora, you mentioned insurance as well as licensing. Should people who are carrying out these non-surgical procedures have insurance?

Yes. Absolutely.

Yes, 100%.

Completely. Everyone carrying out these procedures, no matter who they are, should have insurance.

Yes.

There will be different types of insurance for different procedures but the short answer to that is yes.

My question expands on that point actually. Is there a need for clearer pathways to recourse for patients who have experienced complications from following procedures? If so, what should that recourse and some of those pathways look like? We touched on insurance, but do you have other ideas?

I seem to be doing a lot of the talking, but shall I start with this? The first step is having a list of who is doing what so that you know. That is whether we are talking about beauty therapists, doctors, or nurses, having a licensing scheme or a register so you know who is doing what. Then you have a list to ensure that people are insured. Again, it boils down to the pre-treatment discussion so the patient is aware of the risks, of the aftercare offered, of what is covered, and what will be an additional cost. All that is upfront ahead of a procedure, not discovered afterwards that, “Actually, well, it’s another x number of pounds to fix that,” or, “No, I don’t do that. I would refer you somewhere else.” It is having all that laid out beforehand. There would need to be different levels and types of redress depending on the nature of the procedure. For example, Botox would be different to surgery; microneedling would be different to an injectable. It is not as simple as one pathway would fit all, but everyone undertaking these treatments should have a level of aftercare and a pathway for managing complications. It is okay if they refer to someone else if it is an agreed pathway if that person is better able to manage that particular situation. For example, take a nurse who is licensed to do fillers and who maybe works in a clinic with a doctor. If a complication happens, they can send the patient to the doctor. That is not negligence; there is a pathway in place. The actual pathway will depend on the level of procedure and the practitioner doing it.

But there is a gap.

Just one second, David. Reika wants to come in.

My apologies.

Just a very quick interlude: generally speaking, for hospitals that are carrying out procedures there is an agreement whereby if anything emergent happens within a year or if an emergency procedure is needed, you are covered. Also, if any small modifications are required or, based on assessment, if anything has not gone to plan, then that hospital generally covers any kind of recourse from that point of view. Of course, the problem that I am hoping we will come to is the whole episode of cosmetic tourism and what happens when patients come with quite catastrophic complications. They are two very different concepts really: what goes on in this country and in what setting, and what goes on outside.

We will come on to that now quickly because we have already touched on it quite a bit. Reika, in terms of cosmetic tourism, what work has BAAPS done to educate the public on the risks of cosmetic tourism, and have those campaigns been effective? Do you think the Government need to do more in this?

I think Nora can answer from the BAAPS perspective, but certainly from an NHS perspective because we are at the forefront of receiving, I am sorry to say, some disasters. On a weekly basis, we are still seeing the by-products of complications coming through. Education plays such an immense part, not just through our organisations, BAPRAS and BAAPS, but also through a wider media setting whereby with awareness of generalised coverage of these problems some of us are featuring in more widespread media coverage. The population really needs to be educated about what can catastrophically go wrong.

Is there a need for a specialised insurance for those who are going to seek cosmetic services? Whether we like it or not, particularly if this becomes more regulated in the UK, we may well see an increase in cost of particular or specific kinds of surgeries or cosmetic procedures. We cannot stop people going to do this. Is there another way that we can protect people if it goes wrong? There has been some evidence given to our Committee that actually there are fewer issues with cosmetic procedures done abroad because they are done by medically-trained professionals rather than on the high streets.

It is a bit of a mixed bag on that front. There are excellent clinics with excellent results overseas, but there are some very poor results and poor patient selection cases coming back. It is not as black and white as that. Ideally, insurance would be the answer. It is quite a difficult thing to get insurance in place for obvious reasons, but that would be the ideal situation. BAAPS has approached this on a few fronts. It actively engaged with the Department of Health and Social Care. It has attended the various roundtables that have happened with stakeholders at the Royal College of Surgeons. It has tried to embark on patient education via media and to be as available as possible. As you said, it recognises that you cannot stop people going, so it has put together a list of things they should look for. Some aspects are the same as anyone should look for here, but there are additional aspects to consider if you go overseas. I am speaking from a surgical perspective. Do you know how to check the quality of your surgeon and the clinic or hospital? It is different in every country. You can check it online here. I know not everyone knows how to do it here either, but the specifics vary from country to country. How are you going to access aftercare? Remember, routine aftercare is not just complications, it is routine follow-up as well. What happens if there is a complication before you go home and you have to stay out there longer? Is there an extra cost? What happens if there is a complication when you come home? Those are the additional extras. A couple of years ago, we started a database. We asked members and other medical professionals to submit, not patient identifying data but cases so we can get a sense of what is going on and some themes emerged. It is not complete data—I do not think anyone has complete data—but it is across a range of countries. For the UK, Turkey was the most common with 75% or so of cases. Some procedures are higher risk. Combination procedures, for example, breasts and abdomen, and particularly abdominoplasty or tummy tuck is higher risk. Some of this is inherent in the nature of the surgery. We can see some trends and that data has been very useful even though we know it is incomplete. It has still given a sense of what is out there. Given that Turkey is the most common location for the UK patient to travel to at the moment, we also liaised with our Turkish counterparts and asked what someone should look for if they are going to Turkey. Actually, Turkey has a lot of regulation and standards and there are ways to check that your surgeon, your clinic and so on are compliant. This applies to patients travelling into the UK for surgery as well. If you are travelling overseas for your surgery, you have different aftercare considerations.

If I may give you a little snapshot, Chair and Committee, because you asked about this? I looked at our admissions for the past year. We have had 44 cases of cosmetic tourism-related complications. About 95% of them were from Turkey. We did some approximate costings for how much these patients paid per episode of admission. One lady I dealt with personally was a 30-year-old. She is quite happy for me to share. It was pretty much as close to a near-death experience as you can find. She went for liposuction and came back with a necrotising soft tissue infection. I must have taken her to theatre about three times where I debrided more tissue out of each setting than I could imagine. We saved her life, covered her, and she has recovered and gone back to as much normality as she can. These are not minor complications and probably not a month goes by that at least some minor or major complication does not come through the door. The majority of these are abdominoplasty and breast-related procedures, but if we look at the average cost, if they are admitted, they cost about £6,000 per episode and in an outpatient setting, we calculated around £1,400 just for outpatient wound checks and so on.

In your professional opinion, was that because of poor aftercare, because it was poorly done in the first place, or was she not the right person for it?

For liposuction to cause necrotising soft tissue infection, that is an absolute. It can happen to even healthy patients, but it is a massive undertaking. The problem is who is going to look after this when it happens? You see, if anything happens in this country, then there are responsible bodies but it is very different when they have been shipped across. She pretty much landed almost near death and we had 24 hours to save her life. To be honest, these are not nice episodes to deal with.

I am glad that she is here, and thank you for doing that.

She lived, thankfully.

First, we have this database, but a lot of patients do not end up in a hospital under the care of plastic surgeons. The first thing we need is data. They are talking about instituting a code, but it is not there yet. We need a code that says complication of surgery abroad with sub-classification: did it require intensive care treatment and so on? It can be simple because, of course, people do not like putting more and more data in, but that would help.

I submitted a request at the last call for codes and it was rejected for that.

That is the first suggestion. The second thing is that it might be Turkey now, but cosmetic tourism is not going away. It used to be Prague; it is now Turkey; it will be somewhere else, and it has to do with economic factors. To put it in perspective, last year, Turkey made £3 billion out of cosmetic tourism. I have a friend who is a proper plastic surgeon there. He says the Government will give loans to set up the clinics and you do not need to be a plastic surgeon. You can just be a surgeon, for example, a bowel surgeon. There are financial incentives, and we cannot divorce that. Thirdly is the selection of patients. Some patients are going there for, say, massive weight loss surgery. We would not deem them fit for surgery. We would ask them to lose weight, get fitter, get their diabetes sorted. They do not want to wait, so they go there, and they get complications. It is always that selection factor, so the complication goes up. Another point: when they go to the clinics, they get a certificate of fitness from the clinic to fly back. There are long-term data from the Royal College of Surgeons that say when you are fit to fly in a plane for over two hours or four hours because of the increased risk of deep vein thrombosis. They are giving that certificate because they want them out of the country. That would be another thing to say: an independent certificate could possibly be given at the airport, but this is going to be a big cost and other countries may not want it at the airport. The airlines are putting on more planes because the planes are full of people with hair transplants and so on. These are all factors that impact, and we need data to start with, but it is not going to go away and it is going to cost money. The final thing, which I did not say, is that these package tours and “Oh, my friend’s gone on one of these packages. We’re going to have a holiday.” Why would you want to sit in the sun at 30 degrees when you have just had surgery?

No, I could not think of anything worse, but there definitely has to be some responsibility on the people who market those packages. I am going to come to Catherine next. This probably follows on nicely because we are going to talk about marketing and social media. Before we start, if there is anything that you want to follow up on or you feel that we have not been able to explore as fully as you would like, please follow this up with written evidence or anything else because it is really important that we get as much benefit from your expertise as we can.

I can answer your next questions, but not on how we can target. Certainly, their life is very much online and with social media and they want to be part of the horde and the group of influencers making money. There is a beauty premium in getting a better job if you look good. It is not so much in the UK yet, and it does not work for jobs in the tech sector. However, if you go on the websites of aesthetic surgeons in America they will say—this is for men and women—you are more likely to get a job at an interview, do well and make more money if you have this aesthetic improvement. That is true and because you look good there is a subconscious bias. People see an influencer with lips like this who is making £1 million. “Well, I want lips like that.” I do not, but you know what I mean. The one thing I would like to say before Nora says it, which nobody has covered so far, is how everything we are talking about is going to change tremendously with AI. This is going to be an exponential change and it affects information. If you just put something on Google, the information is changing exponentially weekly, and it is taking over. We need to think almost beyond the social media to how the information is going to be imparted.

Can I come in? We have an agreement with the ASA. In fact, I sat on a Health and Social Care Committee not so very long ago with the ASA. If you do not mind, there are two parts to the question. Samantha raised it, and you have raised it too, Catherine, about younger people and the actual fact of influencing young people. There has been a significant amount of work undertaken by the ASA. I cannot speak for the ASA, but we have evidence of the number of actual posts that it has taken down, particularly relating to advertising procedures where they show before and after images and influencing young people. That is the first thing I will say. Second is working really closely with the Mental Health Foundation. There has been a lot of work undertaken in schools—this is one of Samantha’s questions—producing documentation almost in cartoon fashion for younger people and for parents. The other big influencer coming in here is parental control on censoring access to social media but, interestingly, parental influence on children looking at certain TikTok images as well, so we have been trying to influence parents as much as young people.

With our other inquiries around non-consensual intimate image abuse, we found that parents are not equipped and there are no standardised tools to enable us to do that. You can limit access to certain websites and social media once you are in the house, but you cannot do it when you are out.

That is absolutely correct.

Catherine, I think you have another question.

It is about algorithms, and trying to read those algorithms, but also the online issues are very important here in terms of other legislation that has been passed, although I think some of that has been picked up.

In the Online Safety Act, there was argument around whether this is legal but harmful and whether this should actually fall into the scope of protections and we have not seen that. Particularly for vulnerable adults, not just for young people, we had big conversations about eating disorders for example and body dysmorphia.

Exactly, body dysmorphia.

Unfortunately, none of that is going to be covered by the OSA. As I said, if there is anything you think we have not covered fully, or if there are other things that you would like to input into the inquiry, please do. Thank you so much for your time. This brings this session to a close.