Home : Medical Devices : Composix Kugel Hernia Mesh Patch

Bard Composix Kugel Hernia Patch

Device name: Composix Kugel Mesh Patch
Manufacturer: C.R. Bard

Indirect Hernia - Occurs at the internal inguinal ring. This is the opening in the abdominal wall where the spermatic cord contains structures that go from the abdomen to the scrotum. The structures in the spermatic cord include the vas deferens, nerves, arteries, and the veins to the testicles. These hernias have a sac, which often bulges and causes pain as the sac becomes pinched. Indirect inguinal hernias can be caused by an increase in intra-abdominal pressure during strenuous activities like lifting heavy objects, or they can be congenital.

See our Hernia Glossary

Approved uses: Repair of ventral (incisional) hernias caused by post-surgical thinning or stretching of scar tissue.
Malfunctions:
  • The patch's "memory recoil ring" may break under the stress of intra-abdominal placement, leading to ruptured bowels and/or recurring intestinal fistulae.
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Bard Composix Kugel Hernia Patch

The Bard Composix Kugel Mesh hernia patch is used to repair ventral hernias.  These hernias are caused by post-surgical thinning or stretching of scar tissue.  The patch is generally inserted behind the hernia through a small incision; its "memory recoil ring" allows the device to be implanted while in a folded state, then spring open once it has been properly placed.  The Food and Drug Administration (FDA) recalled issued a recall in December 2005 due to malfunctions of the patch's "memory recoil ring", which have been found to cause intestinal fistulae, punctured organs, and/or bowel rupture in some patients.  The recall was updated in early 2007 when other product codes were found to have the same defect. 

Hernia Patch Recall Affects Thousands of Patients

Ventral hernia sufferers are rushing to their doctors after hearing that the federal Food and Drug Administration (FDA) has issued an updated recall for Bard's Composix Kugel Mesh Patch. The patch, which is used in hernial repair surgeries, was first recalled in late 2005, but the FDA has posted another recall which affects more of the implantable mesh patches on the market. In its recent medical device recall alert, the FDA noted that the Composix hernia patch can break inside the intra-abdominal space of the patient's belly, causing chronic intestinal fistulae and bowel rupture or perforation. read more

Composix Mesh Hernia Patches Can Cause Intestinal Fistulae

Defective "memory recall rings" that lead to punctured organs, bowel rupture, or dangerous intestinal fistulae. They are folded and placed through a small incision, at which point the "memory recall ring" engages, causing the patch to snap open to its full size and begin reinforcing the weakened hernia area. This failure can cause complications in the interabdominal cavity, some of which include bowel issues or even intestinal fistulae. read more

View the Composix Kugel Hernia Mesh Patch Law Articles page here

Composix Kugel Hernia Mesh Patch Glossary

Hiatus Hernia

Ventral Hernia

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Composix Kugel Hernia Mesh Patch Government Articles

Class 1 Recall: Bard® Composix® Kugel® Mesh Patch - Expansion

Class 1 Recall: Bard® Composix® Kugel® Mesh Patch - Expansion

View the Composix Kugel Hernia Mesh Patch Government Articles page here

Composix Kugel Hernia Mesh Patch News Articles

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Composix Kugel Hernia Mesh Patch Patents

Hernia mesh patch

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Composix Kugel Hernia Mesh Patch Wikipedia

Hernia

Incisional hernia

View the Composix Kugel Hernia Mesh Patch Wikipedia page here

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