Bard Composix Kugel Hernia Mesh Patch

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January 12, 2007
EXPANDED RECALL ACTION:

Davol/Bard and FDA notified healthcare professionals of an expanded recall and withdrawal of Large Oval and LargeCircle patches.

Products inlcuded in the expanded recall are:

  • Bard® Composix® Kugel® Large Sized Patch Class IRecall and Market Withdrawal
  • Product Code: 0010202, Bard® Composix® Kugel® LargeOval, 5.4” x 7.0”
  • Product Code: 0010204, Bard® Composix® Kugel® LargeCircle, 4.5”

Hernia Patch Recall?

In late December 2005, the Bard Composix Kugel Mesh Patch was officially recalled by the company that produced it, Davol, Inc., of Cranston, Rhode Island. Soon, the U.S. Food and Drug Administration (FDA) was also warning about the Bard Composix Kugel Mesh Patch, and into 2006 noted additional recalled lot numbers of the product.

What is a Hernia Patch?

The Bard Composix Kugel Mesh Patch was intended to repair ventral hernias. The Bard Composix Kugel Mesh Patch was to be placed behind the hernia during surgery, then held open by a "memory recoil ring". It was that "memory recoil ring" that caused the Bard Composix Kugel Mesh Patch recall notifications.

Apparently, the ring has the tendency to break, which can lead to bowel perforations or chronic intestinal fistulae. Thus, Davol and the FDA asked surgeons and hospitals to stop using the Bard Composix Kugel Mesh Patch.

What tests can be used to determine if the Kugle Mesh has failed?

There are three procedures that can be used to determine if your Kugel Mesh has failed.

  • 1. A lower plate X-Ray
  • 2. Barium fluid swallowed or as an enema
  • 3. Reverse Imaging CT scan

A Hernia Patch may Malfunction.

The FDA urged any patients who received a Bard Composix Kugel Mesh Patch to seek immediate medical attention because the Bard Composix Kugel Mesh Patch malfunction has been associated with "unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms" (FDA website).

The Bard Composix Kugel Mesh Patch product codes related to the Davol and FDA recall are: 0010202, 0010204, 0010206, 0010207, 0010208, and 0010209.

Davol issued another alert to healthcare professionals in March 2006 with advice regarding patients who may have the Bard Composix Kugel Mesh Patch . In the letter, Davol urged any physicians or surgeons whose patients had been given the Bard Composix Kugel Mesh Patch to identify those patients, communicate the dangers about the Bard Composix Kugel Mesh Patch with them, examine them for any reactions, evaluate their situation before and after removing the Bard Composix Kugel Mesh Patch, and report any findings to Davol and the FDA.

Though it was wise of Davol to alert the public to the defects of its Bard Composix Kugel Mesh Patch, there are still many patients who used the devices and may have suffered needlessly. Thus, we encourage those persons to step forward and call our law office today for a free consultation. Anyone who has been adversely affected by using the Bard Composix Kugel Mesh Patch may be entitled to join a class action lawsuit against Davol, and by using our team of legal professionals, you won't owe a dime until restitution is made.

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