On March 7, 2016, doctors at the Cleveland Clinic introduced the nation to Lindsey McFarland, the first person to undergo a successful uterus transplant in the United States. Within hours, however, McFarland was back in surgery: A life-threatening infection forced the organ’s removal, crushing hope she might one day give birth.
McFarland later learned the culprit was Candida albicans, a fungus common in women’s reproductive tracts. In her, it flared into a raging infection that damaged at least two of her arteries, including one that supplied blood to the newly-implanted uterus.
What she did not know is the transplanted uterus had come from a donor suffering from a Candida infection in her bladder — a fact made clear by routine tests conducted by the Miami organ group that provided the uterus.
That group, the Life Alliance Organ Recovery Agency, known as LAORA, claims it alerted McFarland’s surgeons to the infection soon after discovering it. But officials at the Cleveland Clinic said they were not told until weeks later, after the infection had forced the uterus’ removal.
“No one reported the bladder infection to us,” said a Cleveland Clinic official, who asked for his name to be withheld because he was not authorized to speak about the case. “We would have treated it and acted differently.”
The alleged missteps that preceded McFarland’s failed transplant — which have not been previously disclosed — illustrate what critics say is a lack of public accountability in the U.S. transplant system that undermines patient safety. They say the system’s main actors are not required to reveal most mistakes to the government, the rest of the medical establishment or the public. Largely free of such oversight, they are rarely held publicly responsible for errors.
McFarland, 29, and the mother of five adopted children, learned about allegations that LAORA failed to report the infection to her surgeons only recently, from a Washington Post reporter. “We could be having a very different conversation today if that phone call had been made,” she said in an interview.
A Candida infection in an organ donor is a red flag, experts said, because it may develop into a life-threatening problem for transplant patients on immune-suppressing drugs that leave them particularly vulnerable to pathogens. All organ donors must be tested for infections, and positive findings must be reported within 24 hours to transplant teams receiving the organ, according to the United Network for Organ Sharing, which oversees the transplant system.
In a two-paragraph statement, LAORA said it “reported the positive test results within 3 hours.” The group did not respond to requests to specify more clearly when the notification took place.
Lisa Worley, assistant vice president of medical communications and media relations at the University of Miami’s Miller School of Medicine, which oversees LAORA, said “other organs from this donor were successfully transplanted,” an indication that those organs were not infected. She declined to say whether infection had been found in any of them. Worley declined further comment, saying she had no additional information.
But Eileen Sheil, a spokeswoman for the Cleveland Clinic, said LAORA did not acknowledge the bladder infection until more than two weeks after the transplant, when the hospital contacted the group as part of its investigation into what had gone wrong.
Key parts of Cleveland Clinic’s account are corroborated by emails obtained by The Post, in which a person familiar with the case reported the alleged communications failure to U.S. regulators.
The Post met with the author of the emails to ascertain details of that person’s background and the credibility of the information. The Post agreed not to disclose the author’s name to protect the person from retaliation. The Post also corroborated that the emails were sent to regulators several weeks after the transplant.
LAORA is one of 58 nonprofit “organ procurement organizations” chartered by the federal government to collect organs for transplant. Safety standards are enforced by UNOS, another nonprofit that works under contract with the federal government. Only the federal Centers for Medicare and Medicaid Services (CMS) can shut down an organ procurement group but the agency largely defers to UNOS on safety issues.
At the time of McFarland’s transplant, LAORA was a “member not in good standing” of the transplant network — a designation that indicated a “serious lapse in patient safety or quality of care,” according to UNOS. The reasons for that designation are secret, however.
The designation, revealed only by a few paragraphs on UNOS’ website, triggered additional monitoring and other corrective measures, but did not stop LAORA from functioning.
The complaint that LAORA failed to notify McFarland’s surgeons about a donor infection is part of a pattern of reports about organ procurement agencies that has raised concern in Washington. Indiana Sen. Todd Young, R, said he is drafting legislation to tighten regulation of the transplant industry.
“This extremely troubling story is just one more example of the need for greater transparency, oversight and accountability in our organ donation system,” Young said of McFarland’s failed transplant.
McFarland was born without a uterus or fallopian tubes; a uterine transplant offered the only path to pregnancy and childbirth. She and her husband, Blake, had already adopted three boys when she became first in line for the Cleveland Clinic’s groundbreaking uterine transplant program.
“We just wanted that chance,” she said of the prospect of bearing a child naturally. “I really wanted to experience pregnancy, and all of the firsts that come with that, with Blake.”
After undergoing a battery of physical and psychological tests, she underwent surgery over nine hours on Feb. 24, 2016. The transplant was meant to be temporary, intended to give her a chance to have one or two pregnancies via implanted embryos, with deliveries by caesarean section. Then doctors would remove the organ so she would not have to take anti-rejection drugs for the rest of her life.
But the plan went awry on March 7, when McFarland began bleeding. Doctors said they discovered an artery they had connected to supply blood to the uterus was damaged and had no choice but to remove the organ. The cause was subsequently revealed to be the Candida infection.
On March 20, a person familiar with LAORA’S role emailed transplant regulators, claiming LAORA had not notified the Cleveland Clinic about the donor’s positive test for the fungal infection.
The email identified the infection by name and asserted it had been discovered in lab tests within 24 hours after the organ was recovered on Feb. 24 from a woman in her 30s who died at Kendall Regional Hospital in Miami.
“Everyone at LAORA and many in the University [of Miami] know it was LAORA’s fault for not reporting medical findings to Cleveland Clinic transplant team,” said the email, which was sent to UNOS and other transplant authorities. “This is beyond terrible and embarrassing.”
An independent transplant expert said it is highly likely McFarland’s infection came from the donor. But since all women carry the Candida albicans fungus, Cleveland Clinic doctors said they cannot entirely rule out the possibility that fungus in McFarland’s own body grew into an infection after she began taking medication that suppressed her immune system.
Sheil said McFarland was not put on antifungal drugs in advance of the transplant because “fungal infection in a transplanted uterus is a rare and unanticipated complication that had never been seen or reported previously in transplant trials.”
The clinic later changed its protocols to use antifungal drugs in all future uterine transplants.
Goran Klintmalm, chairman of transplantation at Baylor University Medical Center, the only other U.S. uterine transplant program, said the infection “almost certainly came from the donor.”
Klintmalm said the suture line where an artery was connected to the uterus became infected. “That is typical when it comes from the donor,” he said.
While common yeast infections caused by Candida albicans are easily treated, “it is a lethal infection if it gets out of hand,” Klintmalm said.
About a week after the uterus was removed, McFarland suffered another serious complication: She was rushed back into surgery, where doctors discovered she was bleeding internally from an artery in her left leg that was badly damaged by the infection, and they made further repairs.
Three years later, McFarland said she has fully recovered, but is no longer a candidate for a transplant because of the damage to her arteries. She said she remains grateful to the organ donor and her family for giving her a shot at having biological children.
“I’m still a firm believer in uterus transplantation, even if it wasn’t successful for me,” said McFarland, who has since adopted two more children. “I don’t blame the donor at all. … I may not have the happy ending, but there are women out there who are.”
Meanwhile, the Cleveland Clinic has resumed its uterus transplant program. And the program at Baylor has successfully transplanted uteruses into eight women, Klintmalm said. So far, two of those women have given birth.
In December 2017, UNOS reinstated LAORA to regular status. The decision followed corrective actions that UNOS refused to make public as a matter of policy.