Call us Toll Free at 1-866-242-0905 or
Click here to begin your FREE Case Review
EXPANDED
RECALL ACTION - January
12, 2007
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”
Bard Composix Hernia Mesh Patch Injury
Earlier this year, the Bard Composix Kugel Mesh Hernia Patch was the target of a Class I Medical Device Recall by the Food and Drug Administration.
In March 2006, the FDA ordered a recall of the Bard Composix Kugel Mesh Hernia Patch because:
“The 'memory recoil ring' that opens the Composix® Kugel Mesh Hernia 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).
A Class I Medical Device Recall is the highest recall the FDA can enact. By the time of a Class I Medical Device Recall of the Bard Composix Kugel Mesh Patch, there must be significant risk to the public health or safety.
Hernia Patch MalfunctionWhat this means in layman terms is that the patch can collapse under pressure. Should it collapse, it can pierce the intestines and cause serious and potentially life-threatening complications. The Bard Composix Hernia Patch is used to repair hernias caused by the thinning or stretching of scar tissue that occurs after many common surgical procedures. When the patch is placed behind a hernia during surgery, it is held open by the memory coil, but unfortunately due to a defect in the coil it can break and cause severe damage.
The FDA warns that “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 your someone you love was suffered hernia mesh patch injury, you need to contact our hernia patch lawyers immediately. You may be able to pursue a legal case against those responsible for your injury or loss, but if you hesitate the statute of limitations in your state could expire, leaving you with no way to recover financial restitution for your pain and suffering. Let our dedicated and experienced defective medical device attorneys help you with your Bard Composix Kugel Mesh Hernia Patch case today.
