# New rules for hospital staff after IVF death



## Anthony Reid (Jan 1, 2002)

STRICT new rules have been introduced to ensure better care for patients receiving fertility treatment in Irish hospitals.

The guidelines were issued to doctors and nurses after a young woman died when she had a reaction to IVF treatment at the Rotunda Hospital.

http://www.herald.ie/national-news/new-rules-for-hospital-staff-after-ivf-death-1420285.html

/links


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## Lorna (Apr 8, 2004)

Loopyone,

Have you also noticed the rules come from the HSE, and *not* the HFEA.  Which does seem strange as the primary job of the HFEA is to make the rules.  Their secondary job is to look after the “Welfare Of The Child”.  And that is it.

Any way, I suppose as the HFEA is *not* responsible for monitoring complications arising from treatment, they were unaware of a problem, so didn’t see a need for change.  The HFEA reports a death, if someone "dies on the operating table."  If someone develops complications, and dies a week after treatment, then their death is put down to something else.  They didn't die from IVF.

There is an NHS body, that monitors complications due to drug reactions.  A while back, they looked at a number of deaths of women who died within a short time of treatment, and concluded, that one or two of those death certificates, should have said, dies of complications arising from treatment.

There are no official figures of deaths/disability arising from treatment.  No one collects that data.  But from reading news reports, and stuff, I would say, around 5 women(plus or minus 1 or 2), in the UK, die every ten years from treatment.

Carrying on, we know 2-3 women, every year, currently, suffer infections of the abdominal cavity so severe they must have their womb, and ovaries removed, and they must have a bowel resection.  Those that survive, take about a year to recover, and suffer such severe long term health problems they are never able to adopt.

If eSET becomes standard, then women will have to do on average 5 cycles to have a baby, rather than the current 3.  So all deaths and complications will go up, so now around 5-6 women will become sterile, and not be able to adopt.

As far as I am concerned eSET is a propaganda campaign.  The problems women have carrying multiples is overestimated.  For instance, I can’t find any figures that just look at complications of **IVF** multiple pregnancies.  The only figures I can find are for *all* multiple pregnancies.  Only fit women do IVF, but it is possible for a woman who has known health problems to naturally conceive twins, and no one seems to eliminate these women from the figures.

And one of the things that makes me really, really angry about eSET, is that the complications of treatment are presented as minor, when, in fact, the complications can be lifelong disability and death.

eSET was proposed, IMO, in order to save  the NHS money.  And, IMO, eSET is about saving the NHS money, not about the babies born.  And it certainly isn’t about the women going through treatment!

Will eSET save money?  Well the number of women hospitalised every year will increase by about 200 women, some of those women, around 10, will be in intensive care for weeks, and hospitalised for months, maybe a year, and will need lifelong medical support just to get an extra few years of life.

Do a web search on complications of IVF.  With around 27,000 women/couples going through treatment every year, you can crunch numbers, and come up with the figures.  Or do search on my posts, where I have already done this.  OK you will have to go back 1-2 year ago, when eSET was first floated.

Sorry post is a bit rushed, while the weather is good, I want to go raspberry picking,  Gotta get there before the hoardes invade.

Lorna


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## Anthony Reid (Jan 1, 2002)

> For instance, I can't find any figures that just look at complications of **IVF** multiple pregnancies. The only figures I can find are for *all* multiple pregnancies.


Those figures are not recorded. The NHS records do not differentiate between pregnancies that started out via assisted conception and otherwise.

Whilst at an initial eSET meeting in London - the chair (I cant remember if it was Suzie) asked the NHS representatives why they did not record them and they responded with shrugged shoulders. The HFEA then suggested that they should record them - and they noted it.


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## Lorna (Apr 8, 2004)

Tony said:


> > For instance, I can't find any figures that just look at complications of **IVF** multiple pregnancies. The only figures I can find are for *all* multiple pregnancies.
> 
> 
> Those figures are not recorded. The NHS records do not differentiate between pregnancies that started out via assisted conception and otherwise.
> ...


It isn't up to the NHS to collect this data. In fact, the only thing the NHS should be concerned about, is the level of care that pregnant women receive. How the baby/babies was/were conceived, is completely irrelevant. The kind of questions that the NHS should ask, are: "Is the Health Care Professional concerned about the woman, and so should the level of care be stepped up, or are mum and baby so disgustingly healthy, they should be left alone to get on with it?"

The more I think about it, the more I believe, it is unethical for the NHS to ask such questions. We have an organisation, the HFEA, which was set up to make sure that infertility practitioners behaved ethically, and that organisation believes it is OK, to ask NHS personnel to collect data they have no right to know. What does this say about the HFEA's moral standards?

So when the HFEA says that "Those figures are not recorded", how on earth can members of the committee say it is more dangerous for a woman to carry multiples, than go through extra cycles of IVF? They don't have accurate figures for comparison. Surely what you are left with is an educated guess?

Maybe they have a feeling it is the right thing to do.. Well medicine is littered with the dead of doctors who "knew" that this treatment would produce miracles. Look at albumen and burns victims. It wasn't until someone did a double blind study, that we found out, that using albumen on a burn victim is more likely to kill them than doing absolutely nothing. For 60 years, doctors used albumen on burns victims, because they all "knew" it was the right thing to do, and in the process unnecessarily killed over 100,000 burn victims!

Unless you have done the research, you can't for a fact say, one way or the other, whether something is true or not. That has been proved over and over and over again in medicine. But as the HFEA doesn't initiate research, it just puts the kybosh on things, we in the UK are missing the hard facts about treatment. We are catching up now, but most of what seems to be gospel, is in fact based on a strong feeling of what it is right.

And I am as mad as *(*&^&%$*%$%*, because they produce press releases, consultation documents http://www.hfea.gov.uk/docs/The_best_possible_start_to_life_HFEA_public_consultation_paper_April_2007.pdf , speeches at conferences, and so on, that present the issue as a bunch of accurate facts, when it is fact, someone's educated guess.

And if we take the above document, we find reference after reference to the need to care for the welfare and safety of women undergoing IVF, and the children who are born as a result. The HFEA's *only* legal duty is for the "Welfare of The Child". Their only legal duty is to look after the embryo which may or may not implant. The Welfare of women undergoing treatment isn't mentioned in the HFEA Act 1990!

This document goes on and on about the risks of disability and death for multiples. It mentions the risk of death for women carrying multiples. The increased risk of hospitalisation for women carrying more than one baby. But read paragraph 5.3, which discusses the complications of IVF, it just talks about stress, and a possible, unproven, increased risk of cancer. You would think that all IVF causes, is a bad hair day! There is no mention of complications arising from IVF regularly putting women in hospital, or that women might end up disabled or even die!

As far as I am concerned, anyone with a computer, internet access, and reasonable intelligence, can type in the words IVF complications, OHSS or any other combination of words, and come up with pages, and pages of info on complications of treatment. Why didn't the HFEA do that?

If we look at the figures, the results interesting. OK, I estimated that for every 50,000 to 70,000 cycles of IVF treatment, a woman dies of complications. I felt the stated figure of one death for every 25,000 cycles of treatment was too high. That would one and bit women die, in the UK, every year from treatment, or about 11 deaths per 10 years. Too high, IMO.

On the other hand, my gut reaction is that the figures, that say one women is severely disabled for every 5000-10,000 cycles of treatment is correct. That means around 30-50 women are permanently and devastatingly disabled, every 10 years is probably right. What do I mean by permanently and devastatingly disabled? I mean a woman is unable to work, needs to use medication and/or special equipment to survive, can't adopt as too sick, and has a foreshortened life. And the document, "The Best Possible Start To Life" fails to mention the 350-400 women who end up in hospital every year after treatment. I could just go and on about this.

The fact that the HFEA failed to mention any of this, in their document, "The Best Possible Start To Life", speaks volumes. I call this document a piece of propaganda, because it is so heavy on dreadful outcomes for multiple pregnancies, and glosses over complications arising from treatment. What would you call a document, produced by an organisation, that admits it doesn't have accurate figures? A work of fiction? And what is worse, is so many organisations, seem to be repeating the information published in this document!

The document, "The Best Possible Start To Life", has an Executive summary, and in the 2nd column 3rd paragraph, it talks about the conception rates of eSET, that the conception rate has been shown internationally to be achievable without damaging a patient's chance to conceive. Even the HFEA's own figures show, that if everything works perfectly, eSET conception rate is 40%, versus 44% for DET. Same conception rate, IMO, is not the same as *almost* the same conception rate.
And if the freezing/thawing of embryos doesn't work properly, even the conception rates of eSET are down. With eSET you have to have world class cryogenic facilities, top notch specialists doing the freezing/thawing, you have to freeze every possible embryo and so on. And from reading posts on this board and other boards, not all clinics meet those exacting standards.

As far as I am concerned the HFEA has overestimated the problems suffered by mum and babies, and completely ignored any data on complications of IVF; and they have done that to push through eSET. When I read the document "The Best Possible Start To Life", I am lead to believe that multiple pregnancies are life threatening, while IVF is risk free. And that simply isn't true.

Without a lot more data and more accurate data, how can the HFEA weigh up all the facts, look at the pros and cons of eSET versus DET and come to a fully informed decision about eSET? Maybe you know the answer.

Lorna

PS The "one at a time" web site mentioned in the post http://www.fertilityfriends.co.uk/forum/index.php?topic=147313.msg2031922;boardseen#new also suffers from some of the same problems as the document "The Best Possible Start To Life" does. It is an improvement, but it still doesn't give the whole story.


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## Anthony Reid (Jan 1, 2002)

I agree that the HFEA do not produce enough information about the risks of OHSS etc... and when this death happened - I asked the HFEA why they didn't highlight the dangers more. I got a response about the guide to fertility being updated all the time etc...

As for my previous statement - I just realised that it reads wrong - what was suggested was that the information should be recorded by the dept of health. The way I wrote it - it looks like the HFEA want to record it.

But, following on from the above -  I think the issue is about IVF type treatments contribution to the numbers of multiple pregnancies. Its just my opinion of course - but surely its the HFEA's responsibility if the treatment it regulates is contributing to potentially dangerous complications and mc regardless of figures.


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## Lorna (Apr 8, 2004)

Tony said:


> But, following on from the above - I think the issue is about IVF type treatments contribution to the numbers of multiple pregnancies. Its just my opinion of course - but surely its the HFEA's responsibility if the treatment it regulates is contributing to potentially dangerous complications and mc regardless of figures.


Yes the HFEA does have a duty to highlight it. What they don't have a right to do is terrify women/couples. There was some posts a while back, on discussions that were taking place on boards for multiples. There, women who naturally conceive twins, asked whether they should terminate their pregnancy, and try again for a singleton!

I will repeat the only legal responsibility, the HFEA has, is for the "Welfare of The Child", and time and time again, the HFEA, has made this legal responsibility, their sole concern. And I think eSET is a perfect example of putting the embryo, the potential child/children, above and beyond everything else!

Once a women/couple are having problems conceiving, they are faced with a number of difficult decisions. The HFEA has made the choice black and white, transfer more than one embryo and risk damaging your child. The cost to a woman's health of multiple cycles, the possible risk of depression when faced with cycle after cycle of failure, the damage to a family's finances, and so on and so on are completely ignored.

The HFEA has made the potential life , the be all and end all. They haven't given women/couples a bunch of horrible choices to chose from, which is what we really face. They gave us only one. The one they think is right!

When we look at the document, "The Best Possible Start To Life", it implies that the stress levels involved with going through IVF , is about as bad as a bad hair day! 
If you look at the studies of why women/couples give up treatment, even when they haven't achieved their desired family, most give up, because they just can't take any more. Very few give up, on the advice of doctors.

The truth is the stress of Infertility is a lot worse than moving house, changing jobs, etc., and marginally worse than the death of a partner. Yet the HFEA relegate what we suffer, to nothing worse than going out with our hair all messy!

How many people on this board complain that "The Great British Public" doesn't understand IVF. They think that all you have to do is take a few drugs, which are no more dangerous than Aspirin, and that you will instantly fall pregnant. If this read this consultation document, is it any wonder people get the wrong impression?

Reading the document, "The Best Possible Start To Life", it looks like the HFEA is *only* looking at the medical data. It is true that medically speaking for a percentage of women, there is some merit in only transferring one embryo. So out of a 100 women, X will benefit. Which X women will benefit, we can only guess at. And will the women who benefit this time round, benefit next time? We don't know. So even the medical facts aren't exact, but the HFEA present eSET, as a given.

And IVF is about a lot more than medicine. The Infertile also have to weigh up, the short and long term health risks, the effect on our families and ourselves, the costs involved, whether we will still have a job if we carry on with treatment, and a million and one other choices. Infertility isn't just about the medical risks, it is also about the risks to the rest of our lives, and that needs to be recognised.

So yes warn women/couples of the risks involved of multiple pregnancy, but also weigh those risks against the risks of multiple cycles of IVF, and also the damage that will done to women's/couples' lives, if they are forced to go through cycle after cycle of treatment.

Lorna


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## ANonnyMouse (Jan 13, 2008)

Thanks Lorna, that was VERY interesting reading.


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## Anthony Reid (Jan 1, 2002)

http://ukpress.google.com/article/ALeqM5gnpb9FEP1oibtHjnCMzjoF6bWu0w

/links


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## ANonnyMouse (Jan 13, 2008)

thanks for that link Tony, interesting reading.


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## Lorna (Apr 8, 2004)

Having read this article, IMO, everyone is right. How is that possible?

If you look at a member of the opposite sex, and instantly the woman becomes pregnant, then it better for the woman to only carry a singleton.

But&#8230;. for someone like me, who went through cycle after cycle of treatment, and didn't get pregnant, then I have to balance the risks of treatment versus the risks of carrying a multiple pregnancy. I am faced with, excuse the swearing, a set of bum choices. I cannot make a good decision, only a least bad one!

Moving on, I think there is also a cultural divide, between US doctors and European Doctors. Lets start by considering the Hippocratic Oath http://www.pbs.org/wgbh/nova/doctors/oath_modern.html
There are many versions of this, and I have taken the modern version. One of the sections says: "I will remember that I do not treat a fever chart, a cancerous growth, but a sick human being, whose illness may affect the person's family and economic stability. My responsibility includes these related problems, if I am to care adequately for the sick."

From my point of view, there is a marked difference, between papers written by doctors, who trained, live, and practice within Europe, and those written by those whose life is in the USA. It leaps out from the papers. It hit me over the head.

When I read papers written by European doctors, I get to know things, certainly not everything, about the medicine: the risks of treatment A versus B., the effect of this drug versus that drug, the probability of the medical outcome&#8230;&#8230;.

When I read papers written by American doctors, I certainly get to know all of the above, plus, there is a single line, at the end of a lot of papers, that says:
"Is it ethical to &#8230;.."

"Is it ethical to force a woman to go through cycle after cycle of treatment, when each and every cycle, carries a very small, but definite chance of disability or death?"
Is it ethical to transfer only one embryo, when the women/couple involved can't afford to pay for more than one cycle of treatment?"

"Is it ethical to &#8230;.."
That single line is absent from every paper I have read, written by a European doctor. I found, that once I had read a paper published with that line in, reading papers without that line, made me feel very uncomfortable. From my point of view, I believe, that European Doctors, treat patients as a "fever chart or a cancerous growth", while some US doctors, seem to think about " the person's family and economic stability", as well.

I have lost count of the number of people, on BBs like these, who complain that treatment is impersonal, and dehumanises them. Ever wondered why? Perhaps because your European doctor, has absorbed the cultural values, and treats you like a medical problem. A fever chart or a cancerous growth.

I think there is a further interesting cultural divide. I will admit, I haven't looked very hard. I haven't done any serious web searches on this, and you can all shoot me down in flames, because I am talking a load of rubbish. When I scan the World Wide Web, as opposed to looking for UK based information, I come across in the states, BBs run by a clinic, where the doctors answer patients questions on line. I haven't found anything similar in the UK, or in Europe. I found that interesting.

On one of these American BBs, a woman posed, what I thought was, an interesting question. She asked about the number of goes at IVF a woman should do. In the US, there is unanimous agreement, that the maximum times a woman should go through a complete IVF cycle, is 6. Ok doctors will put a woman through more, but only after extensive counselling about the risks. Here in the UK, I sometimes read posts from women/couples who have gone through 8 or 10 or more cycles. That concerns me.

You see, people might say IVF is safe, but is it? Let me explain, my understanding. There are studies that show that IVF is safe, but they looked at women, who had done 3 cycles, and then fall pregnant. Pregnancy counteracts, some of the nasty long term effects of treatment. People like me, who went through 5 cycles, and never got pregnant, are in theory at higher risk of getting some nasty diseases, that only appears 20-30 years after treatment.

I can't find any long term studies, that shows what the happens to women who have done 8 or more cycles of IVF. Is she at greater risk of contracting ovarian cancer, than a woman that does only 3 cycles? As far as I can tell no one knows.

And for me that is a problem. My understanding is that with DET, it takes on average 3 cycles to achieve a live birth, but with eSET it takes on average 5 cycles. Without the long term studies, how can we possibly know that it is safe for women to do eSET?

This might all come back to the fact that the HFEA and clinics, only count deaths from treatment of women, who "die on the table". Women who are hospitalised, or drop dead in the 2 weeks following treatment, don't count as IVF victims. The out of sight out of mind attitude. And women who die 25 years later of Ovarian Cancer, are definitely out of sight.

Moving on, IMO, eSET was proposed to save health services, across Europe, money. Doctors looked at the cost of providing SCBUs and decided the governments could save large quantities of money, with eSET. Again does it save money?

My problem is, I can't find accurate figures for the number of women who are hospitalised, each year, as a result of IVF treatment. And without that data, you can't begin to calculate, what it costs to treat, the 350-400 women, each year, who land up in hospital. Plus some of them will have long term problems. Each year you add approximately 5 women to the long term sick. What are the costs of those?
So how can you calculate, what it will cost to treat the approximately 700 women who will land up in hospital, if eSET becomes compulsory. Plus the 8; plus or minus some, every year, who end up long term sick. So how can you say the costs you save on SCBU, aren't being swallowed up, by all those extra IVF victims. And don't forget the men, who land up in hospital after TESE or MESE. I don't have any data on complication rates for those procedures. That is most likely self interest. I am a woman, who is interested in what happens to women. Sorry men.

And there are additional cost associated with eSET. Clinics must have, absolutely must have, world class cryogenic facilities, top specialist, and be able to freeze every embryo! These are not insignificant costs, and I can't see the cash strapped NHS putting in these kind of facilities!

There is, IMO, one further problem with eSET, a non medical problem, so I don't think there a snowball's chance in &#8230;.. of anyone setting up a study on this.

Let's take 2 couples, both earning the same amount, living in the same town. Mr and Mrs A try for a child and conceive quickly, and also have no problem conceiving child no. 2. Mr and Mrs B try for a child, and can't conceive, so they go for treatment. I would like some studies done, on what sort of lifestyle Mr and Mrs A have, versus the sort of life style Mr and Mrs B have. You know what sort of house they live in, car they drive, holidays they take, whether they eat out etc. You get the idea. Are Mr and Mrs A financially better off than Mr and Mrs B? Also I would like the studies, to look at the relationships, depression, and so on. Are Mr and Mrs B more likely to divorce? Who is more prone to alcoholism, mental illness etc.? Maybe someone can phrase this better.

Bottom line - I want the social studies done. IVF affects so many aspects of our lives, that I think that someone should study, what effect all those extra IVF cycles will have on our lives. I know I live in a dream world.

So why is Dr Norbert Gleicher, being vilified by his European colleagues. I think it is down to peer pressure. European doctors have nailed their colours to the mast and said eSET is the greatest thing since sliced bread.

The infertility laws in Europe, are not about making sure we have the best possible treatment, making sure clinics are up to standard, protecting patients, protecting donors or surrogates, looking after families, making sure you don't fired from your job, or a million or one other things you might think they are about. What are the about? Well IMO, I think they are about control!

Look at what happened when Mr Tarranissi stepped out of line! How could a European doctor speak out against eSET, when all their colleagues, so openly support the system. It would be career suicide to do that!

Another problem I have with eSET, is the way the HFEA went about introducing it. Sure they announced that they were considering introducing eSET, "IVF multiple embryo use reviewed"
http://news.bbc.co.uk/1/hi/health/4724111.stm 
But if you look at this and other stories like, "IVF multiple births 'drain NHS'" http://news.bbc.co.uk/1/hi/health/4120398.stm I feel they had already made up their minds.

The HFEA set a group of experts to consider this "problem". http://www.hfea.gov.uk/en/486.html If you look at the minutes in the first meeting they decided to look at what happened to neonates. They didn't have the answer, yet the press stories were already about how women were risking everything in order to carry twins. Who was encouraging the press to write those stories emphasising the terrible outcomes for multiple pregnancy?

And even after, they have spent hundreds of thousands of pounds considering eSET, they still don't know the answer, to just what are the outcomes for **IVF** multiple pregnancies versus *all* multiple pregnancies.

They talked about finding more about practices in countries that have introduced eSET, like Belgium and Sweden, but places like that have outstanding success rates. There was no discussion about improving success rates here, about complications of IVF for the women trying for a baby, or any social studies. Ok it was a medical advisory group so maybe they wouldn't consider the social studies. But shouldn't they have weighed up the effect of multiple cycles on women trying to get pregnant? There seems to have been a group think about eSET is good, let's introduce it.

In the December meeting of the group of experts, they commented that in Sweden, *only* patients using state funds, are encouraged to use eSET. If you pay for treatment you can use DET. And we know the same is true for Belgium. In the Netherlands, although patients are encouraged to transfer one embryo, even when the state pays they are not forced to. But in the UK, where most patients pay privately, the HFEA, wants patients to be forced to transfer one embryo only!

And finally, the September minutes contained the following lines:
"The Fertility Friends website has been running a discussion on the use of eSET. The discussion has been monitored by group members, and key points reported back to the group. The group were informed that the discussion highlighted a lack of understanding among patients of the risks involved in multiple pregnancies and that it was apparent from the discussion that patients were not receiving proper information about this from their clinicians."

I know I have only scratched the surface of this issue, but I think I have gone on long enough.

So when it comes to eSET, I think patients should be given *all* the available information, not just the stuff deemed by the HFEA fit for us to see. I think patients in conjunction with doctors, should look at individual circumstances, and make the best decision possible. And I think doctors should be encouraged to use those words, "it is ethical to&#8230;"

Good luck to those having to make this difficult decision, and may all your dreams come true,

Lorna


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