First Baby Born To U.S. Uterus Transplant Patient Raises Ethics Questions

Dec 5, 2017
Originally published on December 5, 2017 8:12 pm

Beautiful. Pure. Natural. Medicine at its pinnacle.

Those were the words of Dr. Giuliano Testa this week — the principal investigator of a clinical trial with ten women underway at Baylor University Medical Center in Dallas.

He was talking about the birth of a baby boy to a mother who underwent a uterus transplant last year. It's a first in the U.S., but in Sweden, eight babies have been born to mothers with uterus transplants.

Not everyone is celebrating though.

Dr. Testa and his colleague, Dr. Liza Johannesson, who joined the Baylor team from Sweden earlier this year, spoke with All Things Considered host Kelly McEvers about this development. Excerpts of the interview follow, edited for length and clarity.

Dr. Johannesson, you've delivered a lot of babies, can you describe what this one was like, watching this baby boy be born in Dallas?

Dr. Johannesson: It doesn't really matter how many babies you've delivered ... This was a very special moment.

Dr. Johannesson, you've been through this in Sweden, we mentioned that eight babies have been born there to mothers with transplants. How complicated a procedure is it?

Dr. Johannesson: Well it's a transplant, and it's a completely new transplant. .... I think we can compare it to a hysterectomy. When it comes to the donor surgery, probably a little bit more complicated than a simple hysterectomy. It takes about five hours. For the recipient, the transplant itself takes about five hours too. ... Then after you have the transplant, you don't have an immediate success. First you have to know the uterus is staying with the recipient, then you have the periods coming, showing it's viable, then you have to implant the embryo, and then finally you have a pregnancy and then you have to wait the nine months before you have a baby. So the actual success is one and a half years down the line. That's very rare in transplants.

We should mention, Dr. Testa, some of the other women who have been involved in this trial have had transplants that were unsuccessful. What lessons did you learn from those?

Dr. Testa: Well we learned a lot of emotional lessons. ... They trusted us for doing something that for them was of extreme value. We were not able to deliver. So that was a big humbling lesson in itself. And then all the scientific information we got, we were able to apply to the woman who came afterwards, and now we are successful. So I really feel for the first ones.

We mention that not everyone is celebrating this. It raises some ethical questions. Is it possible with a procedure that is so experimental, so risky, to get informed consent from women who desperately want to have a baby?

Dr. Testa: I doubt it is possible for lay people to have informed consent about anything we do in medicine, if you ask me. This is even more complicated because we are going into uncharted waters. ... I think that we go through years of studying to understand what we do, and to achieve mastering the things we do. And then we pretend that in ten minutes we can explain something to anybody. ... I don't think it's really possible.

... We try to use the simplest terms we can think about and then we leave it to the autonomy of the patients, in this case not even patients, these women, to make the decisions. I think we really refrain, and it was really important for us, from any pressure of any kind from our side but then of course, the inner pressure of this woman to have a child I think drove the entire process and their decision at the end.

What about the risk for the baby? What possible complications do you have to consider?

Dr. Johannesson: So in that sense, we know a lot. That's maybe the only aspect of this that we actually have a good knowledge of because females have been giving birth after kidney and liver transplants for many many years on immunosuppressive drugs. So we know what the effect of immunosuppressive drugs has on pregnancies, on babies, on recipients. And we know which immunosuppressive drugs you should not take during pregnancy.

Dr. Testa, women and families do have other options to have a baby — adoption, using a surrogate mother. I wonder how you think about that, about committing scarce medical resources to solving a problem that does have other solutions.

Dr. Testa: True, I don't have a very intelligent answer to this question. I just understood through this process that I myself had completely underestimated the wish of any woman that I've met thus far to have their own child. I don't know whether there is a price for it. I have no philosophical discussion to add. I just have to say that it was a humbling discovery and I'm still profoundly touched by it.

Dr. Johannesson: I think it's important to say also that it doesn't exclude surrogacy or adoption. We're just offering this as a complement treatment.

You're adding this to a menu of options. Which raises the cost question: This is not a cheap procedure to go through. Right now as part of a clinical trial, this is being paid for with research funds, I gather. It is not clear that people's insurers are going to pay for this going forward, which means you may perfect this technique and women may desperately want it and may not be able to afford it.

Dr. Testa: That's absolutely true. But this is true for infertility at large in this country. ... Some woman will go to extremes to be able to have this experience. The cost of medical care is at any rate extremely high for anything we do. As I said, I don't know whether this is really an important question, who's going to pay and how. I doubt the insurers will ever pay for something like this.

What is the cost?

Dr. Testa: We are collecting all the data. ... I assume it's going to be a similar cost that we face today for a kidney transplant. ... The ballpark is, I would say around $200,000 to $250,000.

What's next? You have another mother in the trial who is pregnant?

Dr. Johannesson: We do, we have one that's in an advanced stage of pregnancy. So next up is her delivery. Then we have a couple of other women in different stages of the procedure, so we're hoping for a very happy 2018.

All Things Considered host Mary Louise Kelly and senior producer Andrea Hsu contributed to this report. Greta Jochem is an intern on NPR's Science Desk.

Copyright 2017 NPR. To see more, visit http://www.npr.org/.

MARY LOUISE KELLY, HOST:

Beautiful, pure, natural, medicine at its pinnacle - that is how Dr. Giuliano Testa described the recent birth of a baby boy to a mother who underwent a uterus transplant last year. Testa is leading a clinical trial at the Baylor University Medical Center in Dallas. It involves 10 women who all suffer from what is known as absolute uterine infertility. This was the first such birth here in the U.S. In Sweden, eight babies have been born to mothers who've had uterine transplants.

Today we reached Dr. Testa and his colleague Dr. Liza Johannesson, who was part of the Swedish team and is now at Baylor. I began by asking Dr. Testa how they connected with the women in their study.

GIULIANO TESTA: Well, they applied. There is an application process for it. We went through their medical history. We went through their psychological history. And then we all sat around a table, and we thought that those were the best candidates for the initiation of the trial.

KELLY: And the idea - just so that people understand the surgery, the idea is that once the mother has a baby, the uterus would then be removed. Is that correct?

TESTA: Well, that's correct. And that's the beauty of it because that means the medication that are needed can be withdrawn.

KELLY: The immune suppression drugs that a mother would have to take to keep her body from rejecting.

TESTA: Yes. Those are good drugs because they do the job they have to do, but sometimes they come with side effects. And so the sooner you get them out, the better it is.

KELLY: Dr. Johannesson, you've been through this in Sweden. We mentioned eight babies have been born there to mothers with transplants. How complicated a procedure is it?

LIZA JOHANNESSON: I think we can compare it to a hysterectomy when it comes to the donor surgery - probably a little bit more complicated than a simple hysterectomy. It takes about five hours. And for the recipient, the transplantation itself takes about five hours, too. So it's fairly complicated. And then after you have the transplant you don't have immediate success.

First you have to know that the uterus is staying with the recipient. Then you have to have the periods coming, showing it's viable. Then you have to implant the embryo. And then finally you have a pregnancy. And then you have to wait for the nine months before you have a baby. So the actual success is one and a half years down the line. And that's very rare in transplants.

KELLY: And we should mention, Dr. Testa, that some of the other women who have been involved in this trial have had transplants that were unsuccessful.

TESTA: Unfortunately so.

KELLY: What lessons did you learn from those?

TESTA: Well, we learned a lot of, number one, emotional lessons. They trusted us for doing something that for them was of extreme value. We were not able to deliver. So that was a big humbling lesson in itself. And then all the scientific information we got we were able to apply to the women who came afterwards. And now we are successful. So I really feel for the first ones.

KELLY: I wonder. Is it possible with a procedure that is so experimental, so risky - is it possible to get informed consent from women who are - who desperately want to have a baby?

TESTA: I doubt it is possible for lay people to have informed consent about anything we do in medicine, if you ask me. This is even more complicated because we are going into uncharted waters. We try to be as precise, as open as possible. We try to use the simplest terms we can think about. And then we leave it to the autonomy of the patients - in this case, these women - to make the decisions. I think we really refrain from any pressure of any kind from our side. But then of course the inner pressure on these women to have a child I think drove the entire process and their decision at the end.

KELLY: Dr. Johannesson, what about the risk to the donor? This is a woman who would be considering having her uterus transplanted out of her body, given to another woman in a highly experimental procedure and one that isn't needed for the purposes of saving a life.

JOHANNESSON: It's quite different here in the U.S. than it was from Sweden because we were immediately contacted by I think 90 women who wanted to donate their uterus to a person they never met and to a person they never were supposed to meet. So that's...

KELLY: Really? Ninety women reached out...

JOHANNESSON: Yeah.

KELLY: ...And said that they wanted to participate.

JOHANNESSON: Yeah. Altruistic donors, meaning that they don't know the recipient. So there was a great interest from women to donate their uterus. And it's always risks associated with a surgery. But if the surgery goes well, you won't have any long-term effects by removing the uterus. And these were all women that had their own children already and formed their family and were happy with that.

KELLY: What about the risk for a - for the baby? I mean, what possible complications do you have to consider?

JOHANNESSON: So in that sense, we know a lot. And that's maybe the only aspect of this that we actually have a good knowledge of because females have been giving birth to babies after kidney and liver transplants for many, many years on immunosuppressive drugs. So we know what the effect immunosuppressive drugs has on pregnancies, on babies and on recipients. And we know also which immunosuppression drugs you should not take during pregnancy.

KELLY: Dr. Testa, another question for you, which is this. Women and families do have other options to have a baby - adoption, using a surrogate mother. I wonder how you think about that, about committing scarce medical resources to solving a problem that does have other solutions.

TESTA: True. I don't have a very intelligent answer to this question. I just understood through this process that I myself had completely underestimated the wish of any woman that I have met thus far to have her own child. These women are willing to undergo three surgeries at least - the transplant itself, the delivery must be done by C-section, and then the removal of the uterus. This is not a small token. This is a big deal. And when people are willing to go through this - and their husband, I have to say, are great men as well - well, there is something deep that is driving this.

JOHANNESSON: And I think it's important to say also that this doesn't exclude surrogacy or adoption. We - we're just offering this as a complement treatment. So for some people, the surrogacy or the adoption or just living a child-free life will be perfect. But for some people, they might want to go through a uterus transplant, and we can now offer that.

KELLY: So you're adding this to a menu of options...

JOHANNESSON: Yes.

KELLY: ...Which raises the cost question. This is not a cheap procedure to go through. Right now as part of a clinical trial, this is being paid for by research funds, I gather. It is not clear that people's insurers are going to pay for this going forward, which means you may perfect this technique, and women may desperately want it and may not be able to afford it.

TESTA: That's absolutely true. But this is true also for infertility at large in this country. I doubt that the insurers will ever pay for something like this. But I know that some families will really go through extremes to be able to have this experience.

KELLY: What is the cost?

TESTA: I assume it's going to be the similar cost that we face today for a kidney transplant. I would say around $200,000, $250,000.

KELLY: Dr. Johannesson, you've delivered a lot of babies. Can you describe what this one was like, watching this baby boy be born in Dallas?

JOHANNESSON: This was a very, very special moment when we had that boy. And he screamed immediately when he came out of the womb. And Dr. Gunby held him up to show the parents how beautiful he was, and you can just see pure joy and tears in their eyes. I think we all got tears in our eyes, too. There were 30 people in the room, and everyone was just quiet.

KELLY: Well, Dr. Johannesson and Dr. Testa, thank you.

JOHANNESSON: Thank you.

TESTA: You're welcome. Thank you.

KELLY: That's Dr. Liza Johannesson and Dr. Giuliano Testa of Baylor Medical Center in Dallas.

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