Posted in Defective Medical Devices on September 15, 2012
A significant number of kidney donors are suffering life-threatening injuries because of the use of surgical clips to close arteries after kidney surgery. Surgical clips can slip off of the small portion of an artery that is left after the removal of a kidney and cause fatal blood loss.
The number of patient deaths from the use of clips has created interesting issues of liability. Teleflex, the manufacturer of the surgical clips, says that it is well understood within the medical community that the clips are unsafe to use in kidney donors. The device manufacturer would therefore consider kidney donor deaths linked to surgical clips as issues of medical malpractice, not product design defects.
Many leading surgeons disagree and say that the medical device manufacturer fails to adequately warn practitioners of the hazards of the clips for kidney donors. The manufacturer fails to provide any warning directly on its product labels. The manufacturer instead sends letters to hospitals warning them not to use the clips in kidney donors. The warning letters are often lost or ignored by hospitals, and surgeons not that the letters fail to mention the serious consequences of using clips in kidney donors.
“It’s shocking that it doesn’t say that even a single donor died,” one surgeon said of the warning letters. “It’s meaningless without saying that.”
Source: CNN, “Kidney-donor deaths linked to surgical clips raise issues of alerts, warnings,” John Bonifield and Elizabeth Cohen, June 21, 2012