The Vascu-Guard patch has been linked to reports of severe internal bleeding, blood clots, hematoma, embolisms, stroke, and death. The FDA is especially concerned when it is used to repair blood vessels in the neck.
Need a Texas Vascu-Guard Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
Overview
Baxter International Inc. manufactures the Vascu-Guard Peripheral Vascular Patch. It is a piece of cow tissue used for reconstructive surgery on major blood vessels in many parts of the body.
FDA Warning After Injuries & Deaths Reported
In September 2016, the FDA issued a Safety Alert for the Vascu-Guard after reports of severe bleeding, hematomas, and three patient deaths.
What is the problem?
The Vascu-Guard patch is associated with severe, life-threatening health risks — especially when it is used during Carotid Endarterectomy (CEA), which is a surgical procedure to open and clear blood vessels in the neck. According to the FDA:
“After CEA surgery in particular, arterial bleeding in the neck could rapidly lead to airway obstruction, hypoxia, diminished brain perfusion, stroke and/or cardiac arrest.”
FDA Recommendation
Doctors and patients should be vigilant for symptoms of bleeding in the neck, such as swelling or difficulty breathing.
The FDA also recommends considering other types of patches, including those made from pieces of a saphenous vein or prosthetic patches made out of Dacron or polytetrafluoroethylene (PTFE).
Analysis of the Problem
The label on the Vascu-Guard patch includes warnings about dehiscence (wound separation) at the surgical site, which could cause serious bleeding, hematomas, and infection. The FDA is investigating why so many reports of bleeding have been linked to CEA surgeries.
Vascu-Guard Patch Recall
In June 2015, Baxter issued a recall for the Vascu-Guard patch after
customers reported having problems implanting it correctly. Baxter received several reports of patients who experienced post-operative thrombosis (blood clots), embolisms, and strokes. Click here to read more.
What is a Hematoma?
A hematoma is an abnormal collection of blood outside a blood vessel but inside the body. They occur when a damaged blood vessel causes internal bleeding. Symptoms may include:
- Pain
- Swelling
- Redness
- Bruising
- Weakness
- Visible mass or lump
Need a Vascu-Guard Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Vascu-Guard lawyers for a free lawsuit review.