<"https://www.yourlawyer.com/practice_areas/defective_medical_devices">XenMatrix, a mesh used in hernia and abdominal wall repair, is being recalled by C.R. Bard’s Davol Inc. subsidiary. According to the company, testing couldn’t assure the XenMatrix mesh met regulatory guidelines for toxins released by dead bacteria.
According to a report from Dow Jones Newswire, the XenMatrix product is made from pig tissue. An official with the company told Dow Jones the issue is not with the product itself, but rather the testing mechanism. The spokesperson said there have been no patient injuries or complaints, and that the company has fixed the quality control problem at issue.
The XenMatrix recall was announced on Tuesday in a filing with the U.S. Security and Exchange Commission. There has been no official announcement from the U.S. Food & Drug Administration.
This is not the first time a mesh product marketed by C.R. Bard has been the subject of concern. Between December 2005 and March 2006, specific lot numbers of defective <"https://www.yourlawyer.com/topics/overview/Composix_Kugel_Mesh_X_Large_Patch">Bard Composix Kugel Mesh hernia repair patches were recalled after it was found that the memory recoil ring, which opens the patch, could potentially break under the stress of placement in the intra-abdominal space and lead to chronic intestinal problems such as bowel perforations and chronic intestinal fistulae. Thousands of lawsuits involving the Kugel Mesh patch have since been filed against the company.
Recently, lawsuits have also been filed alleging Bard was negligent in designing its Avaulta vaginal mesh, and failed to warn patients of possible complications with <"https://www.yourlawyer.com/topics/overview/Bard-Avaulta-Mesh-Complications-Lawyer-Lawsuit-Attorney">Bard Avaulta mesh. It is believed that the Bard Avaulta surgical mesh design inhibits surrounding tissue from receiving nutrients and oxygen, causing impaired healing. This can lead to complications that may require further surgery.
Lawsuits involving the Bard Avaulta mesh have been consolidated in a multidistrict litigation in the U.S. District Court for the Southern District of West Virginia. The Bard Avaulta lawsuits will be presided over by U.S. District Judge Joseph Goodwin.