When patients undergo surgery to donate an organ, the artery formerly connected to the removed organ is closed off via use of staples or surgical clips to prevent internal bleeding. In May 2011, the U.S. Food and Drug Administration (FDA) issued a warning to alert the public that use of surgical clips, such as the Weck Hem-o-Lok Ligating Clip, to close the renal (kidney) artery had reportedly been defective in some patients.
“The Food and Drug Administration (FDA) and the Health Resources and Services Administration (HRSA) are alerting health care providers that Weck Hem-o-Lok Ligating Clips should NOT be used for the ligation of the renal artery during a laparoscopic living-donor nephrectomy because of serious risks to the donor,” the FDA warning letter said.
According to the safety alert, the clips have been linked to 12 injuries and three deaths from 2001 through 2005. They were linked to three additional fatalities since 2006. Once such fatality to make news recently involved the death of a 41-year old mother of four, Floridna Gotcher, who died in 2011 in an effort to give her brother a kidney so that he could survive.
In 2006, Teleflex, the maker of Weck Hem-o-Lok surgical clips, sent warning letters to hospitals and medical professionals to caution them against using these devices in kidney donor surgeries. Many medical professionals, however, have criticized Teleflex’s efforts as inadequate and unsuccessful.
The FDA’s 2011 warning regarding these surgical clips pointed out the following makes and models as being contraindicated (unsafe to use) for renal donor patients:
- Weck Hem-o-Lok ML Medium Large Endo 5 (544230)
- Weck Hem-o-Lok L Large (544240)
- Weck Hem-o-Lok XL Extra Large (544250)
- Weck Endo5 Hem-o-Lok Medium Large (ML) Automatic Endoscopic Applier (543965)
Even though the warning letter was issued last year, critics argue that safety communications such as these may not be effective enough when it comes to fatal risks. Telefex, in a statement to CNN, said the company believes surgeons are well aware that they should not use the clips in kidney donors.
"A contraindication is a clear, well understood and accepted concept in the medical community that says, ‘Do not use this device for this purpose,’" Teleflex wrote in a statement to CNN.
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For more information, or if you believe you or a loved one was injured by medical negligence, contact the injury lawyers at Flood Law Group today.