The Bard ® Composix ® Kugel™ Mesh Patch is used to repair ventral (incisional) hernias. Hernias are usually repaired by a simple operation in which a surgeon stitches the stomach muscles back together, but this is not always possible because the stomach muscles are often too weak or thin for the surgery, in which case a Bard Composix Kugel Mesh Patch may be used.
If the patch is used, it is placed behind the hernia and then lays flat against the inner body cavity so the hernia won’t push through the tissue wall. Unfortunately, these patches can break, leading to bowel perforations and chronic intestinal trauma. Other symptoms may include severe pain, nausea, vomiting, or a large bulge at the site of the previous surgery. Kugel-Mesh Recall The FDA issued a Class I recall for the Composix Kugel Mesh Patch—the strongest recall available to the FDA—reserved for dangerous or defective products that predictably could cause serious health problems or death. The Class I recall was issued on December 22, 2005, and then updated on March 31, 2006, to include additional lots of defective patches.
The FDA instructed surgeons and hospitals to immediately stop using the recalled products and return the unused patches to the company. The FDA has also advised patients who have received this device to seek medical attention immediately if abdominal pain, fever, tenderness at the implant site or other unusual symptoms occur.
If you or someone you care about had a hernia surgery where a Bard Composix Kugel Mesh Patch was used and was injured as a result, you need knowledgeable and experienced New York Kugel Mesh attorneys on your side. You may be entitled to compensation, even if you have an implanted device on the recall list but have not experienced any symptoms. The attorneys at Gersowitz, Libo & Korek, P.C. are dedicated to protecting your rights and to holding negligent parties responsible for your injuries. We want to hear your story.
Here’s how to reach us:
–For fastest service, call: 1-800-529-9997, or
–Fill out a New York Personal Injury Case Consultation form.
We’re eager to hear your story, answer your questions and lay out all of your available options. All at no risk and no cost to you. That’s right. Our consultations are completely FREE. So call us now at 1-800-529-9997.
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