Bard® Composix® Kugel® Mesh Patch Recalled - Hernia Patch Failures Noted

The FDA has listed a Class 1 Recall of the Bard® Composix® Kugel® Mesh Patch. You may also know it as a Hernia Patch.

The FDA states:

 

"The 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 FDA notes that "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)."


The FDA says:

  • Surgeons and hospitals should stop using the recalled product and return unused units to the company.
  • Patients who have who have been implanted with one of the recalled devices 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.

If you have been implanted with one of these recalled devices, learn more about your options and get an Instant Answer to your questions. Call today and speak with an Attorney: 1.800.838.0800.

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