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Class 1 Recall of Bard Composix Kugel Mesh Patch

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Patients who have been implanted with a Bard Kugel Mesh Patch used in hernia repair surgery should be aware that the product has been recalled by the manufacturer and patients should seek medical attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.

The Bard Composix Kugel Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is 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 problem with patch involves the memory recoil ring” that can open and break under the stress of placement of the large sized products in the intra-abdominal (inside the belly area) space. The risk is bowel perforation (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs).

We have had clients present with a pointed object pressing out on the skin from inside the abdomen. Others have presented with perforations of other organs of the body. If you have received one of these patches it would be wise to seek medical consult and where necessary, legal representation.