Doctors prepare for first U.S. uterus transplants

By PAIGE FRANK For The News-Letter

Doctors at the Cleveland Clinic, led by Dr. Andreas G. Tzakis, plan to be the first in the country to successfully complete a uterus transplant, promising to help many women who otherwise would not be able to become pregnant.

The procedure has been done before, but never in the United States.

Sweden recently became the first country to successfully complete such a transplant. At the University of Gothenburg, nine women had uterus transplants. The first gave birth in September 2014, and since then, three others have given birth as well.

So far, all of the babies born to women with transplanted uteri were premature but otherwise healthy. Two of these researchers’ transplants failed, one due to a blood clot and the other due to infection, and the organs had to be removed.

Saudi Arabia and Turkey are the only other countries that have attempted uterine transplants, but neither has succeeded. This may soon change, though, as Cleveland is not the only hospital currently preparing to attempt the procedure. Others hospitals in both the U.S. and Britain are on track, but Cleveland is by far the closest.

Within the U.S., there are an estimated 50,000 women who could be considered eligible for a uterus transplant. These are woman who would otherwise never have the opportunity to experience childbirth due to lack of a uterus or damage to the uterus. About one in 4,500 women have ovaries but lack a uterus.

Dr. Tommaso Falcone, the Cleveland Clinic’s chairman of obstetrics and gynecology, recognizes the novelty, and perhaps the strangeness, of the procedure. He was initially very skeptical. It wasn’t until he visited Sweden in 2013 to see the surgical team there that he began to understand its value. He observed a uterus transplant surgery and met with the couples undergoing it.

“I almost cross-examined them,” Dr. Falcone said. “I was thinking, ‘There’s got to be something wrong with these people.’”

After talking to them, though, he began to realize just how important pregnancy can be to a couple.

“It’s a legitimate request. I got on the plane and knew I would be at the forefront of trying to make this program work at the Cleveland Clinic,” he said.

Tzakis, the other driving force behind the project and the director of solid organ transplant surgery at the Cleveland Clinic, agreed.

“There are women who won’t adopt or have surrogates for reasons that are personal, cultural or religious. These women know exactly what this is about. They’re informed of the risks and benefits. They have a lot of time to think about it, and think about it again. Our job is to make it as safe and successful as possible,” Tzakis said.

The greatest risks lie with the surgery and the anti-rejection drugs that patients are required to take. Doctors must consider the risks for the mother and the fetus, which will be developing in a uterus taken from a deceased individual. The baby will be exposed to all of the drugs that the mother ingests.

Risks are reduced slightly by the fact that all the potential candidates are otherwise healthy women. Thousands of women have delivered healthy babies while taking anti-rejection drugs for transplants, many of whom may have not been as initially healthy as the women eligible for the uterus transplants.

Additionally the few side effects that have been linked to anti-rejection drugs — pre-eclampsia (a pregnancy complication involving high blood pressure) and slightly smaller babies — have not even been proven to have been a direct result of the drugs.

Besides the risks for the woman, the second-greatest concern has been the ethicality of the procedure. Jeffrey Kahn, a Johns Hopkins University medical ethicist, spent time evaluating the procedure and ultimately did not find any ethical qualms with the idea.

“We’re doing lots of things to help people have babies in ways that were never done before,” Dr. Kahn said. “It falls into that spectrum.”

The only other options for the women the procedure targets are adoption or surrogacy. Surrogacy, because it requires the exchange of money, has the potential to be exploitative of poor women. The transplant then, he says, is ethically superior to this option.

Where organ transplants used to be aimed solely at saving lives, doctors at Cleveland Clinic see no reason why transplants can’t be expanded to simply improve patients’ quality of life. Their goal is to give the chance to experience pregnancy to women who thought they never could.

The ultimate goal of the transplant procedure is to take the uterus of a deceased organ donor and transplant it into a woman who lacks a uterus for a temporary period of time. After having a maximum of two babies, the uterus would be removed to allow the woman to stop taking transplant anti-rejection drugs.

As of now, the Cleveland Clinic has eight potential women who have been selected for the transplants and have begun the screening process. When the time comes for them to receive surgery, surgeons will remove their cervix and part of the vagina in addition to a damaged uterus. The new uterus will be connected to the patient’s vagina and the uterine vessels will be attached to the large blood vessels running outside the recipient’s pelvis. The ovaries of the patient, however, will not be connected to the transplanted uterus. This means natural pregnancy is still impossible for the patient. After a year of healing, the recipient will be able to attempt in vitro fertilization.

The fertilization procedure is prepared for well before the uterus transplant takes place. The women are given hormone treatments to stimulate egg production and at least 10 of their eggs are secured, fertilized with the partner’s sperm and frozen for later use.

The Cleveland Clinic plans to begin with 10 trial recipients. Tzakis will be in charge of the surgeries. To prepare for the uterus transplants, Tzakis spent time with the Swedish team, observing all nine of their transplants.

The Swedish team did not stick to deceased donors like the Cleveland team plans to. They performed transplants that removed the uterus of a woman past menopause. The live surgeries often used the recipient’s mother as the donor, which meant the babies born using the transplanted uterus essentially came from the same womb as their mothers.

The live-donor procedure is riskier than the procedure Tzakis plans to perform. Removing the tiny blood vessels necessary to the uterus from the live donor’s other tissues is risky. The uterine vessels are wound around the ureters, which carry urine from the kidneys to the bladder.

Prior to the procedure, recipients go through a thorough screening process. They must be in a stable relationship and free of psychological disorders, which are common requirements for most organ transplants.

Finances are also taken into consideration, as the women must spend a significant amount of time living in or near the clinic.

After all the preparation and screening the women are not even guaranteed a procedure. They go onto a waiting list where they must wait until a matching donor becomes available. As for the actual procedure, the doctors predict the surgery should take about five hours to complete.

The entire transplant project is the accumulation of a year of careful thought. A 15-member ethics board evaluated the research plan extensively before it was approved. When the researchers were finally given the go-ahead, the staff was completely in support of the plan.