Last month, we wrote about the danger of drug and medical device warnings and recalls that go unnoticed by hospitals and doctors, much less patients. A recent story reported by CNN demonstrates the tragic consequences of such ignorance.
When Florinda Gotcher entered the hospital to donate one of her kidneys to her brother, recalled her daughter, Melinda Williams, "She was so happy. She was overwhelmed that she was able to save her brother's life."
Kidney donor surgery is relative safe: According to CNN, in in 2010, the year before Gotcher's surgery, 6,276 people donated a kidney. Thirty days later, they were all still alive. Mere hours after her surgery, Gotcher was dead.
Williams said that surgeons from University Medical Center in Lubbock, Texas told her Gotcher experienced massive, sudden internal bleeding after her laparoscopic procedure, and that they’d done everything possible, but that nothing could save her.
Really?
Kidney donation surgery requires cutting the renal artery. If it’s not properly closed, patients bleed to death. Staples or clips typically are used to close the artery, and both methods are considered safe. Except for laparoscopic kidney donation.
Clips are not indicated for the arterial stump because they can slip off. Four people are known to have died from exactly this circumstance, and 12 others suffered injuries. When Gotcher was taken back into the operating room after her collapse, her clips were found floating in the pool of blood that had collected in her abdomen.
This should have surprised no one, as the clips’ manufacturer, Teleflex, in 2006 began sending warning letters to hospitals that the clips were unsafe for use in laparoscopic kidney donor surgeries. Hospitals received at least three and as many as six such letters.
In addition, the product package bears a warning symbol directing doctors to review the instructions accompanying a separate tool used to apply the clips, which make clear that the clips should not be used on kidney donors.
Officials at University Medical Center acknowledged receiving the letters in 2006, but said they hadn’t purchased those clips that year. By the time they did, the letters had been forgotten, simply one more of the dozens the hospital received every year concerning safety issues.
Many medical professionals believe warning letters don’t go far enough, and that warnings should be posted directly on the devices themselves. The FDA disagrees, stating that the letters are “effective,” never mind that only about half the hospitals mentioned in documents obtained by one researcher acknowledged receipt of the warning notifications.
And the agency appears to have undercut its initial analysis, given that after Gotcher’s death it issued another notice reminding surgeons of the clips’ unsuitability for kidney donor surgeries.
As the FDA told CNN, "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."
University Medical Center settled a lawsuit over this tragedy, and acknowledged that its process to track warnings failed. Now it uses an outside contractor to document and track warnings and recalls.
But it’s too late for Florinda Gotcher.
