FDA Issues Warning for Weck Hem-O-Lok Ligating Clips

The U.S. Food and Drug Administration (FDA) just issued a warning for <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">Weck Hem-o-Lok Ligating Clips. This medical device, said the FDA, is contraindicated for ligation of the renal artery during laparoscopic living donor nephrectomy, known as kidney removal for kidney donor transplant surgery.

The FDA wrote that it notified health care providers that Weck Hem-o-Lok Ligating Clips should not be used for the this purpose due to concerns of serious risks to the organ donor. The clips may become dislodged, which can lead to uncontrolled bleeding, additional surgery, or donor death.

In 2006, the manufacturer added this contraindication to the “Instructions for Use” after receiving 15 reports of 12 injuries and three deaths which occurred between 2001 and 2005. Since the contraindication issued in 2006, there have been three more kidney donor deaths, all linked to the contraindicated use. Complications have occurred within hours of surgery.

The Weck Hem-o-Lok Ligating Clip is a V-shaped clip made from a non-absorbable material that comes in various sizes. It is used to permanently close bleeding vessels or tissue structures.

While there are published journal articles that appear to endorse the continued use of Weck Hem-o-Lok Ligating Clips for ligating the renal artery during laparoscopic living donor nephrectomies, the FDA and HRSA are stressing to health care providers that the clips are contraindicated for this use because of potential life-threatening complications. Also, the Organ Procurement and Transplantation Network (OPTN) and the American Society of Transplant Surgeons both issued separate safety notifications reinforcing the contraindication to their members and to all OPTN-approved living-donor kidney transplant programs.

Weck Hem-o-Lok Ligating Clips that are indicated for laparoscopic use and which are contraindicated for ligation of the renal artery during laparoscopic living donor nephrectomies and include:

• Weck Hem-o-Lok ML Medium Large Endo 5 (544230)
• Weck Hem-o-Lok L Large (544240)
• Weck Hem-o-Lok XL Extra Large (544250)
• Weck Endo5 Hem-o-Lok Medium Large (ML) Automatic Endoscopic Applier (543965).

Urologists and Kidney Transplant Surgeons are advised not to use and hospital staff are urged to remind urologists, transplant surgeons, and operating room staff to not use the Weck Hem-o-Lok Ligating Clips for the ligation of the renal artery during laparoscopic living-donor nephrectomies because of the risk to living donors.

Patients are warned that if they are considering donating a kidney, to talk to their health care provider about the potential for surgical complications; the methods used during living donor surgery, and the advantages and disadvantages of each method; and the risks and benefits associated with donating a kidney.

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