The recipient of the first uterus transplant performed in the United States is recovering well and looking forward to the next phase of the research project: pregnancy, according to the team of Cleveland Clinic surgeons who performed the groundbreaking Feb. 24 transplant.
“I’m pleased to report to you that our patient is doing very well,” lead surgeon Dr. Andreas G. Tzakis said during a press conference on March 7.
The transplant recipient, known only as “Lindsey” to protect her privacy, is a 26-year-old woman with uterine factor infertility (UFI). She was selected from among more than 250 applicants to undergo the 9-hour procedure involving transplantation of a uterus from a deceased organ donor of reproductive age. She is the first of 10 women set to undergo the procedure as part of the Cleveland Clinic study.
“Lindsey” made an appearance at the press conference and expressed, first and foremost, her “immense gratitude” to the donor’s family.
“They have provided me with a gift that I will never be able to repay,” she said in an emotional statement in which she shared about learning at age 16 that she would never be able to have children.
“From that moment on I prayed that God would allow me the opportunity to experience pregnancy, and here we are today at the beginning of that journey,” she said.
Lindsey will undergo a year of anti-rejection treatment prior to undergoing in vitro fertilization; her eggs were previously fertilized using her husband’s sperm, and the embryos are in cryogenic storage, according to Dr. Rebecca Flyckt , another member of the surgical team.
The embryos will be transferred one by one until the goal of a healthy pregnancy and healthy baby delivered by cesarean section is achieved, Dr. Flyckt said.
After one or two successful pregnancies and births, the uterus will be removed. Although substantial evidence suggests that anti-rejection medications are relatively safe in pregnancy, minimizing and ultimately eliminating the need for them is advisable, thus uterus transplants, at least under the Cleveland Clinic research protocol, are meant to be temporary.
Uterus transplants are performed to enable patients – who have either lost their uterus to disease or who were born without a uterus or a functioning uterus – to experience pregnancy and childbirth.
Prior to the Cleveland Clinic transplant, nine had been performed successfully with healthy outcomes (the first post-transplant baby was born healthy in 2014). All were performed at the University of Gothenburg in Sweden. Dr. Tzakis traveled there to work with surgeons prior to performing the procedure at the Cleveland Clinic, where he is the Transplant Center program director.
Addressing the bioethical issues surrounding uterine transplant was an important part of this project, according to team member Dr. Ruth Farrell , a bioethicist and ob.gyn. surgeon at the Cleveland Clinic.
“Despite the name uterine transplant, the focus of this procedure is not on the uterus. It’s on women and children and families,” she said, adding that to understand the ethical issues of uterine transplant, it’s important to consider the perspectives of women with UFI.
“For instance, women born without a uterus have a medical condition that affects every aspect of their lives, from the time they are diagnosed in adolescence, to when they are adults looking for relationships and trying to decide if and how to have a family,” she said, adding that “these women face the real possibility of never having children.”
But this advance in reproductive medicine and science also requires a close look at how the potential risks and benefits of uterine transplant weigh against existing options of adoption and surrogacy. While there are many successful stories involving surrogacy and adoption, these options are not available to all women because of “legal, cultural, religious, and other very personal reasons,” Dr. Farrell said.
“Our research on uterine transplant, we hope, may give women another option which may work better for them and their families,” she said, also noting that while living donor transplants have been performed, these come with some risk, thus deceased donors are being used for the current study.
As for the feasibility of uterine transplant, many questions remain to be answered, according to Dr. Tommaso Falcone , chair of the department of obstetrics and gynecology at the Cleveland Clinic, who said that the procedures done as part of the current study will be paid for by an institutional grant.
While the American Society for Reproductive Medicine contends that infertility is a disease worthy of insurance coverage, that is “outside of our hands,” he said.
Indeed, while this first uterine transplant in the United States is a “huge and exciting breakthrough,” and while “the folks at Cleveland Clinic should be congratulated,” the possibility of this procedure ever being covered by insurance and being available to women outside of the research protocol is questionable, especially given the available alternatives, such as gestational carriers and surrogacy, Dr. David A. Forstein, a reproductive endocrinologist at the University of South Carolina, Greenville, said in an interview.
In a patient-centered model, this “tremendous, wonderful gift from science” would give patients – like the 1 in 5,000 women in the United States who are born without a uterus – a very viable alternative, but the question is whether having one’s own children is a right, and whether extensive financial resources should be committed to helping women achieve that, he said.
Dr. Charles E. Miller , a reproductive endocrinologist in Chicago, and head of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital in Park Ridge, Ill., agreed that this transplant is to be celebrated.
“It’s a big moment, to say the least,” he said in an interview.
But Dr. Miller also questioned the feasibility of the procedure and whether society will “look favorably upon donation,” given the availability of alternatives for which there is now great success.
“I salute the pioneering effort,” he said, “But at the end of the day, can society take on this burden of a procedure performed not to sustain life, but to help create life? That’s a tough one.”