Surgical clips used in kidney donor surgery have been linked to injuries and deaths, prompting questions about warning labels by manufacturer Teleflex Medical. A hospital in Texas recently settled a lawsuit with the family of Florinda Gotcher, who bled to death shortly after laparoscopic surgery to donate a kidney to her brother in 2011. As some of our readers may already know, in order to perform kidney donor surgery, surgeons must cut the renal artery and then close it up. Some surgeons use staples and others use surgical clips to close the artery. Although the surgical clips are used in many types of surgeries, they can slip off the renal artery and lead to internal bleeding.
Between 2001 and 2005, three deaths and 12 injuries were reported to have been caused by use of the clips in kidney surgery. In April 2006, Teleflex sent letters to hospitals and added a contraindication on its instructions, but failed to add warnings about use in kidney transplant surgery on its packaging or on the clips themselves. A number of surgeons have sought these warnings. In May 2011, the FDA and Health Resources and Services Administration issued a joint safety communication that said there had been three more kidney-related deaths since the 2006 contraindication.
The agencies reminded urologists, surgeons and hospital staff not to use the Weck Hem-o-lock Ligating Clips for laparoscopic living-donor kidney transplant surgeries. University Medical Center in Texas, which settled with the Gotcher family, had received the letters in 2006 at a time when the hospital did not purchase the clips. By the time it purchased them years later, the letters appeared to have been misplaced and/or forgotten.
Source: Lawyers USA Online
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