FDA Recall: Bard Composix Kugel Mesh Patch

LATEST NEWS FROM THE FDA

January 12, 2007 - EXPANDED RECALL ACTION:
Davol/Bard and FDA notified healthcare professionals of an expanded recall and withdrawal of Large Oval and Large Circle patches.

Products inlcuded in the expanded recall are:

• Bard® Composix® Kugel® Large Sized Patch Class I Recall and Market Withdrawal
• Product Code: 0010202, Bard® Composix® Kugel® Large Oval, 5.4” x 7.0”
• Product Code: 0010204, Bard® Composix® Kugel® Large Circle, 4.5”

In March 2006, the Food and Drug Administration announced a Class I Medical Device Recall for the Bard Composix Kugel Mesh Patch due to the likelihood of potentially catastrophic failure of the device.  This recall follows a 2005 warning that the patch may potentially be defective.

Thousands of people have had the Bard Composix Kugel Mesh Patch implanted in them after undergoing surgery to repair ventral hernias caused by the thinning or stretching of scar tissue.  The patch is placed behind the hernia through a small incision, and the memory recoil spring allows the patch to be folded for insertion and later spring open and lay flat once it is in place.

The main failure of the device is the memory recoil ring that opens the patch can break and fail if large sized products are placed in the intra-abdominal space.  Should the patch break, it can lead to bowel perforations and chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).

Class I Medical Device Recall

A Class I Medical Device Recall is the highest recall the FDA can enact for a defective medical device like the Bard Composix Kugel Mesh Patch. If a product presents a real danger to the health or safety of the consuming public, the FDA attempts to act as quickly as possible to ensure that the fewest people are hurt by the defect, but unfortunately these failures are often only detected after someone suffers from the side effects of the product.

It is unknown how many people will be affected by the potentially dangerous Bard Composix Kugel Mesh Patch, but it is clear that this product presents a clear and present danger to the safety of thousands of people.

If you or someone you love was adversely affected by the Bard Composix Kugel Mesh Patch, you must move quickly to take immediate action. You may have the right to financial compensation, but if you hesitate the laws in your state called statute of limitations could expire, leaving you with no way to legally fight back against those that were responsible for your pain and suffering. Let our dedicated and experienced defective medical device attorneys help you get the restitution you deserve. Contact us today.

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