In January 2011, Florinda Gotcher donated one of her kidneys to her brother who was battling kidney disease. The low-risk surgery seemed to go well, but just hours later Gotcher was dead.
Surgeons at University Medical Center in Lubbock, Texas tried to save her life. When Gotcher took a turn for the worse, they rushed her back into the operating room and discovered something horrible. When they removed her kidney, they put clips on an artery. But the clips fell off and Gotcher, mother of four, bled to death, at age 41.
Keeping them Honest, Gotcher's death was preventable.
Starting in 2006, the FDA, working with the manufacturer of the clips, sent up to six letters to hospitals warning them the clips were unsafe in laparoscopic kidney donor surgeries.
However, an audit by the FDA a year later showed only about half the hospitals acknowledged getting the letters.
The letters also never mentioned patients had died.
Yes, before Gotcher lost her life - there were other donors who met the same fate.
Gotcher was the fifth kidney donor to die because of the clips, while at least 12 others were injured.
Tonight on 360, you'll meet Dr. Amy Friedman, a transplant surgeon in Syracuse, New York, who for the past eight years has tried to get the FDA to do more to warn hospitals and patients the clips can kill kidney donors.
The question many people are asking is could the FDA have done more to prevent the deaths?
Hear what the FDA has to say, along with the manufacturer of the clips tonight on the program.
CNN's Senior Medical Correspondent Elizabeth Cohen brings you this story at 8 and 10 p.m. ET.
The bleeding probably started postoperatively after it appeared that all the bleeding was controlled. Tough to blame the hospitals or the surgeons if they were following the standard of care, and no one was informed that a specific type of surgical clip was failing too frequently. Why sue the clip manufacturer if the clips were being used for something they were not intended, how can you hold the hospitals liable if they were never informed by the FDA or the surgeons if they were practicing the same way across the country? This needs to be corrected and addressed, but this is not murder. And, I can't say this meets the criteria for malpractice. Bad outcomes don't equal malpractice. This story does not provide enough evidence to say for sure if the clips even were at fault, or if there was some other error or complication.
Not only should the FDA, the clip manufacturer and the hospital be sued, but they should all be tried for murder. This is medical malpractice and if the only way to get changes made are through the courts, it has to be done that way.
Where these claps used during the surgery while she was on the table? If so, would they not have been able to to see the excessive bleeding at the time?
If the clips work themselves loose and fall off after the surgery is complete I would say the clip manufacturer and whomever approved their use should take the lion's share of the blame. On the other hand everyone was alerted to the problem with these particular clamps so if there were no other clamp choices to make then the hospital and surgeons should have refused the surgery until the design problems were fully corrected. Surely there are other better ways to permanently clamp off arteries and veins? Real scary...
When clamps are applied during surgery everything may appear fine even up to closing. However, even the slightest movement, like a transfeer from op table to recovery bed, can cause things to change. The clamp manufacturer, and the hospitals who continue to use them despite being sent warning letters, should be held accountable to the fullest extent of the law. There have been failures of other medical devices (like pacemakers & articificial heart valve for instance) which have failed. Holding medical facilities & the corporations who make the devices accountable is the right thing to do.
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