The first woman to undergo a uterus transplant in the US has had to have the donated organ removed due to a sudden complication.
The transplant recipient - a 26-year-old woman from Texas, known as Lindsey - underwent the 9-hour operation on February 24, 2016, as part of a clinical trial for the treatment of uterine factor infertility (UFI).
UFI is the inability to conceive or carry a pregnancy successfully due to problems involving the uterus, including uterine fibroids, congenital abnormalities, Asherman's syndrome and Adenomyosis.
It is estimated that around 3-5% of women worldwide have UFI, and current treatment options for the condition are limited.
The transplant was the first of 10 that have been planned for the trial, which received approval from Cleveland Clinic's Institutional Review Board last November.
The disappointing news comes only days after a press conference was held by the Clinic, in which doctors hailed the transplantation as a success.
But in a statement released yesterday, the Clinic revealed that Lindsey - who was born without a uterus - had experienced a sudden complication that resulted in the surgical removal of the transplanted uterus.
"At this time, the circumstance of the complication is under review and more information will be shared as it becomes available," said hospital officials.
"Unfortunately I did lose the uterus to complications," Lindsey confirmed in a statement. "However, I am doing okay and appreciate all of your prayers and good thoughts."
Uterus transplantation a complex, highly experimental procedure
The Clinic point out that there is a known risk with solid organ transplantation, and there are circumstances in which the organ may have to be removed.
Uterus transplantation is more complex than other forms of transplantation, primarily because once the donor uterus is transplanted into the recipient's pelvis, the blood vessels of the uterus must be connected to those of the recipient.
While still considered a highly experimental procedure, uterus transplantation has shown strong potential as a treatment option for UFI.
In 2014, Medical News Today reported that a 36-year-old woman from Sweden had become the first ever to give birth after a uterus transplantation. Up until September 2015, nine uterus transplants had been performed in the country, resulting in five pregnancies and four births.
The success of uterus transplantation in Sweden has spurred other countries to trial the procedure. In September 2015, doctors in the UK approved a clinical trial in which 10 British women will undergo the operation, and shortly after, the US followed suit.
Clinical trial is ongoing
While all Swedish uterus transplantations to date have used live donors, Lindsey's procedure was conducted using a deceased donor - a 30-year-old woman who had previously given birth but who had died suddenly.
- Around 1 in 5,000 women are born without a uterus
- At present, the only way these women can have a genetically related child is to use a surrogate mother
- Uterine fibroids - non-cancerous tumors that grow on the walls of the uterus - are a common cause of UFI.
At a news conference, Ruth M. Farrell, an obstetrician and gynecologist at Cleveland Clinic who is part of the US clinical trial, said that live uterus donation had previously led to "some complications," encouraging their decision to use a deceased donor.
There is no suggestion, however, that the use of a deceased donor was involved in treatment failure, and the team says it might consider using live donors for future transplantations.
Despite the initial US transplant yielding disappointing results, the Cleveland Clinic say the trial is ongoing, "with a commitment to the advancement of medical research to provide an additional option for women and their families."
Speaking shortly after the approval of the US clinical trial last November, Dr. Andreas Tzakis, of the Transplantation Center at Cleveland Clinic - who is leading the research - sounded confident that uterus transplantation could transform the lives of many women with UFI.
"The exciting work from the investigators in Sweden demonstrated that uterine transplantation can result in the successful delivery of healthy infants," he said.
Earlier this year, MNT reported that in vitro fertilization (IVF) patients in the UK are to be offered a new form of treatment that allows fertilization to take place inside the body.