Surgical clips used in kidney donor surgery have been linked to injury and deaths, prompting questions about warning labels by manufacturer, Teleflex Medical.
A hospital in Texas recently settled a lawsuit with the family of a woman who bled to death shortly after laparoscopic surgery to donate a kidney to her brother in 2011.
When the victim’s brother developed a deadly kidney disease, his sister was so thrilled to find out she was a perfect match and could save his life. She scheduled her surgery immediately. Her daughter recalled that her mom didn’t worry about the risks of surgery, she was so happy to help her brother.
Statistically, kidney donor surgery is considered to be very safe; in 2010, one year prior to her surgery, 6,276 people donated a kidney and none of them died within thirty days of the surgery.
Her laparoscopic surgery went well, but approximately 30 minutes later, while in the recovery room, the victim mysteriously took a turn for the worse.
“She just took a deep breath and her eyes got real huge and then she fell back down and started breathing really, really bad,” her daughter said.
Surgeons at University Medical Center in Texas rushed her back into the operating room. Once they opened her up again, they saw a pool of blood in her abdomen. The 41-year-old mother of four had died from a massive, sudden bleed. Apparently, the clip slipped off.
Back in 2004, transplant surgeon, Dr. Amy Friedman, began raising concerns about using clips in kidney donors, sending letters to the U.S. Food and Drug Administration (FDA) and making presentations at transplant conferences and even publishing articles in medical journals.
The clip packaging allegedly does have a warning symbol advising doctors to look at instructions, which state that the clips should not be used on kidney donors.
In 2006, Teleflex, the manufacturer of the clips, sent warning letters alerting hospitals that the clips were unsafe for use in laparoscopic kidney donor surgeries. Hospitals received anywhere from at least three to six letters alerting them. Officials at the hospital where the victim’s surgery took place admitted that they did receive the 2006 letters, but at that time they were not purchasing the clips. Years later, when the hospital did purchase the clips, the letter was forgotten about.
Dr. Amy Friedman says the letters did not go far enough to alert doctors not to use the clips on kidney donors. She said that they did not mention that kidney donors actually died when the clips were used on them. “It’s shocking that it doesn’t say that even a single donor died. It’s meaningless without saying that,” she said.
According to documents obtained by Dr. Friedman through the Freedom of Information Act, in 2007 the FDA called these letters “effective” and “adequate to prevent a reoccurrence of the problem,” even though only about half the hospitals acknowledged receiving the notification, according to a 2007 audit by the FDA.
However, after the victim’s death, the FDA issued a safety notification reminding surgeons that the clips are contraindicated for kidney donor surgeries.
In a statement to CNN, the FDA stated that when the clips are used correctly, they could effectively control bleeding. The agency added that while most surgeons complied with their warning, “despite repeated efforts to communicate this important safety information, some transplant surgeons continue to improperly use these clips. While the FDA can warn against the unsafe use of a medical device, doctors are not prohibited from using cleared or approved devices for an unapproved use within their practice of medicine.”
Five kidney donors have died and twelve others have suffered injuries due to the clips, according to CNN.
The hospital settled a lawsuit filed by the victim’s family for an unspecific sum. To the family, none of this can bring her back. She died trying to save her brother.
Contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).