Kugel Hernia Mesh Patch Information Use:
The Composix® Kugel Mesh Patch is/was used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is/was placed behind the hernia defect through a small incision. The patch is/was then held open by a “memory recoil ring” that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.
The Kugel mesh hernia patch is used to repair ventral hernias. There are over 750,000 hernia operations each year in the U.S. The Kugel hernia mesh patch is manufactured by C.R. Bard, Inc., and their subsidiary, Davol, Inc. who owns the patent on the device. The Kugel mesh patch is made of two pieces of mesh that surround a flexible plastic ring. The surgeon places the mesh patch in a small incision. The surgeon would fold the patch and place it at the site of the hernia. The released ring would then spring back into its original shape, flattening the patch. The meshlike material would serve as a substrate, allowing the hernia patient's own tissue to grow and assist in healing the hernia.
The Kugel Mesh Patch can break, however, leading to bowel perforations and chronic intestinal fistulae. These are very serious conditions that pose a significant health risk to Kugel hernia patch patients. The problem with the Kugel hernia patch is that the plastic component could break and cut through a patient's internal organs and tissue. The FDA has received reports of more than 80 injuries and other problems possibly related to it, including several fatalities.
The Bard Composix Kugel Mesh Hernia Repair Patch Recall has been upgraded by The United States Food and Drug Administration to "Class I" because the defect associated with the use or exposure to the Bard Composix Kugel Mesh Large Patch has a reasonable probability to cause serious adverse health consequences, including death. The "memory recoil ring" that opens the Composix Kugel Mesh Patch after it has been inserted into the intra-abdominal space can break. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
The FDA issued an immediate recall of Bard Composix® Kugel Mesh Hernia Repair Patches on December 22, 2005 and updated the list again on January 10, 2007. The FDA has advised patients who have received this device to seek medical attention immediately if abdominal pain, fever, tenderness at the implant site or other unusual symptoms occur. The FDA has instructed surgeons and hospitals to immediately stop using the recalled products and return the unused patches to the company.
Reason for Recall:
The "memory recoil ring" that opens the Composix® Kugel Mesh Patch can break under the stress of placement of the large sized products in the intra-abdominal space. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
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