Improper Use of Hem-o-lock Surgical Clips Leads to Hemorrhaging and Death
CNN.com posted a story today about a surgical device known as the “Hem-o-lock” surgical clip, and it’s definitely worth reading. These clips are designed to close a blood vessel so that it can safely be cut without significant bleeding. Many surgeries require the intentional transection of blood vessels, and there are a number of techniques and devices that can be used to accomplish this task. The Hem-o-lock clips are just one of a number of possible techniques a surgeon can use. The problem, however, appears to be that some surgeons are using the clips in certain situations where they are unreasonably dangerous.
When the donor’s kidney is removed (this removal is called a nephrectomy), the artery that supplies that kidney (the renal artery) must be transected and permanently sealed. Despite a warning from the FDA in May of 2011 indicating that “Weck Hem-o-Lok Ligating Clips should NOT be used” to seal off the renal artery in live kidney donors because of “serious risks to the donor,” there are some surgeons who continue to use the clips in this way. In fact, when the clips were relatively new to the market, there were even a few studies in which the authors advocated the use of the clips for this exact purpose. In one European Study from 2006, the authors concluded that “The Hem-o-lok technique is easy, safe, and rapid and offers cost savings when compared to [other methods]. We recommend its use during laparoscopic nephrectomy and live donor nephrectomy.”
But just 2 months after that European Study was published, the FDA issued notice of a Class 2 Recall and the manufacturers of the device changed the product labeling to include a specific warning that the clips should never be used to seal off the renal artery in a live kidney donor surgery, because the clips can fall off the artery, leading to uncontrollable internal bleeding. This warning was prompted by a series of injuries caused by these clips, including three deaths, in live kidney donors. What’s even more worrisome, though, is that even after this warning was added to the product labeling, some surgeons have continued to use the clips in settings where they have been proved to be unsafe.
Kidney donors are not the only patients that need to worry about this device! The reason the clips fail in the kidney donors’ surgery is two-fold. First, the renal artery is fairly large, and branches directly off the abdominal section of the aorta–the largest artery in the body, and the point at which the blood pressure inside is highest. Additionally, the blood in an artery pulses with each heart beat. In large vessels, the clips may not be strong enough to stay in place with each pulsation of the blood in the artery, and they may slide off the cut end of the artery they’re supposed to hold closed.
The second reason why the device has failed in these donors is found in the nature of the surgery itself. Once removed from the donor, the donated kidney has to be connected to the recipient’s blood supply. This means that most of the length of the donor’s renal artery is left attached to the donated kidney. Surgeons try to preserve as much of the renal artery as they can, to make the implantation and ‘plumbing’ of the new kidney into the recipient’s blood supply easier. By taking the length of the renal artery with the kidney, they leave behind a very short segment of the artery on which to attach the clamps. With each pulse of the artery, the clamp may slide a tiny bit, until ultimately, it slips of the end of the short arterial stump.
So, the combination of attaching the clips to the short stump of a large-diameter, pulsating artery (and perhaps even a large vein) appears to be the combination of circumstances that sets the stage for device failure–and that scenario is not unique to kidney donors undergoing nephrectomies. There are any number of surgeries in which arteries are transected and must be permanently closed.
Not every poor outcome following surgery is the result of negligence. If injuries result from the use of a device in circumstances where it is specifically contraindicated, however, this may be an indication of medical negligence. People who have been seriously injured by a bleeding event following surgery may want to seek legal representation to learn what their rights are and whether litigation may be appropriate.