Cases - Bard Composix® Kugel Mesh Hernia Patch
What is Kugel Mesh?
The Bard Composix® Kugel Mesh Hernia Patch is used to repair ventral hernias. The Patch is manufactured by C.R. Bard, Inc., and their subsidiary, Davol, Inc. who owns the patent on the device. The 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 mesh-like material would serve as a substrate, allowing the hernia patient's own tissue to grow and assist in healing the hernia.
What are the medical and legal issues with Kugel Mesh?
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 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. (See the Recall Notices and Affected Device List).
The "memory recoil ring" that opens the Bard 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 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.
Contact us to Discuss Your Claim
We are now evaluating claims for patients with non-Recalled Bard Composix® Kugel Hernia Mesh Patches as well as recalled ones. If you or a loved one has had hernia surgery and received a Bard Composix® Kugel Patch please contact our Indiana based class action lawyers to assess any potential claim and possible lawsuit.
The Bard Composix® Kugel Mesh Hernia Patch is used to repair ventral hernias. The Patch is manufactured by C.R. Bard, Inc., and their subsidiary, Davol, Inc. who owns the patent on the device. The 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 mesh-like material would serve as a substrate, allowing the hernia patient's own tissue to grow and assist in healing the hernia.
What are the medical and legal issues with Kugel Mesh?
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 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. (See the Recall Notices and Affected Device List).
The "memory recoil ring" that opens the Bard 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 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.
Contact us to Discuss Your Claim
We are now evaluating claims for patients with non-Recalled Bard Composix® Kugel Hernia Mesh Patches as well as recalled ones. If you or a loved one has had hernia surgery and received a Bard Composix® Kugel Patch please contact our Indiana based class action lawyers to assess any potential claim and possible lawsuit.
