Weck Hem-o-Lok Surgical Clips Linked to Kidney Donor Deaths: Report

Some surgeons continue to use Weck Hem-o-Lok surgical clips for kidney transplant operations, despite warnings and a number of patient deaths, federal health officials warn. 

According to a report by CNN last week, FDA officials say that Weck Hem-o-Lok Ligating Clips are still being misused in a number of operating rooms throughout the United States, exposing kidney donors to a risk of potentially life-threatening problems.

The surgical clips have been contraindicated for kidney surgery since last year, following several patient deaths and a number of reported injuries.

Despite multiple letters to hospitals warning about the risk of problems with the surgical clips for kidney donors, there are some surgeons who have either not read the updated instructions that come with the surgical clips or have not seen the letters. Some critics indicate that the continued use may be partially because there are no clear warnings on the box.

The packaging only has a warning symbol that advises doctors to go read the instructions that come with a different surgical instrument, which is used to apply the clips. Those instructions have the updated warning against use of the surgical clips during kidney transplant surgery, but some surgeons may never see them since they are rarely kept in operating rooms with the surgical clips themselves.

In May 2011, the FDA issued a safety communication warning that the surgical clips should not be used to clamp the renal artery during laparoscopic living-donor kidney transplant because they can come dislodged. This can lead to uncontrolled bleeding, severe injury and death.

As of last year, there have been at least six kidney donor deaths associated with use of the surgical clips over the prior 10 years.

Since 2006, hospitals have received several letters from Teleflex, the manufacturer, warning that the clips were unsafe to be used during kidney transplant surgery. However, those letters never mentioned that the clips had been linked to patient deaths.

According to the CNN report, only half of the hospitals acknowledged even receiving the letters and in some cases the letters went out before hospitals began using the clips and the hospitals did not make the link between the two.

A number of medical associations have warned transplant surgeons about the clips, but some experts say that the answer is to put the warning directly onto the clips themselves. In at least one case, a hospital was forced to settle a medical malpractice lawsuit brought by the family of Florinda Goucher, who died on the operating table during transplant surgery at University Medical Center in Lubbock, Texas, in 2011.