FDA Issues Warning to Medical Personnel over Vascu-Guard Patch
After receiving numerous troubling reports of failure of the device, the US Food and Drug Administration (FDA) has recently issued a letter warning surgeons against using the Vascu-Guard Peripheral Vascular Patch during certain types of vascular surgery. The FDA warned the doctors that patients could face severe negative health consequences when using the device, including serious bleeding.
The Vascu-Guard patch is a patch composed of bovine tissue that can be used in vascular reconstruction in veins throughout the body. The patch is manufactured by Baxter International. The product was approved by the FDA in November of 2014 through the 510(k) process, which permits approval of devices that have not undergone any human testing when the manufacturers can show that the device is substantially similar to other devices already approved by the FDA.
Baxter issued a recall of certain lots of the Vascu-Guard patch in June of 2016, explaining that it had received reports of adverse results from surgeries where the patch was used. The recall may be expanded to all lots of the Vascu-Guard patch, pending the results of an investigation by the FDA.
In its warning letter to physicians, the FDA clarified that while the patch could be used in a number of locations throughout the body, the reports of complications have been received regarding Carotid Endarterectomy (CEA) surgeries, or surgeries which clear an artery in the neck of blockages to prevent strokes. The FDA warning letter noted that at least three patients had died shortly after they had undergone CEA surgeries where the Vascu-Guard patch was used, as well as patients who had experienced other severe health consequences. The FDA stated that patients on whom the patch is used run the risk of experiencing wound separation (also known as dehiscence). This can result in severe bleeding, infection, hematomas, embolisms, blood clots, and strokes. Patients who have recently undergone surgery where the Vascu-Guard patch was used should be on the lookout for symptoms of a hematoma, which is a semi-solid accumulation of blood resulting from a broken blood vessel. Symptoms include pain and swelling, bruising, a visible bulge under the skin, and weakness in the area.
If you have experienced serious side effects after a California surgery involving the Vascu-Guard patch or another dangerous medical device, contact the compassionate and dedicated Los Angeles personal injury and medical device litigation attorneys at Magaña, Cathcart & McCarthy for a consultation, at 310-553-6630.