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Medical Devices

Kugel Hernia Mesh Patch Linked to Serious Injuries

Hernia Mesh Patients Have Legal Rights

Did you or a loved one undergo hernia repair surgery? If so, you may have a faulty hernia mesh patch. If you have not already experienced complications, it is possible that you could in the future.

FDA records show that as far back as 2002, Davol Bard began to receive complaints about broken rings in the extra large versions of the patch. Davol initially blamed the broken devices on doctors improperly folding the patches for placement during hernia repair. It was not until December 2005 that Davol ran tests and realized that the broken rings were not due to doctor error, but rather failure at the ring weld. In 2006, the FDA found that Davol was tracking complaints about the hernia patch improperly and that adverse reports were understated.

Did You Suffer Complications from a Kugel Hernia Mesh Patch?

  • If you think you may have a Davol Hernia Mesh Patch, you have legal rights and are urged to contact Mark & Associates, P.C. today for a FREE legal consultation.
  • Many people are unsure what method of hernia repair they underwent and are unsure if they have one of the recalled patches. Our attorneys can examine your records to help determine if you have one of the defective patch models.
  • In many cases, our defective medical device lawyers are able to win compensation for patients who suffered complications as a result of a defective hernia patch.
  • Mark & Associates, P.C. takes NO legal fees whatsoever unless we win or settle your hernia patch case.
  • Call 1-866-50-RIGHTS (1-866-507-4448) to speak with a lawyer today, or fill out our case review form and someone will contact you.

The Patch Recall

On January 10, the manufacturer of the hernia mesh patch, Davol Inc., recalled models of its hernia patch due to defects that lead to serious complications.

This was a recall expansion of a previous recall; recalled models included Bard Composix Kugel Large Oval and Large Circle Mesh Patches for product codes 0010202 (Large Oval) and 0010204 (Large Circle). The January 10 recall is in addition to previous Davol Kugel Hernia Patch recalls.

The recall is due to what is called a memory recoil ring, which is the mechanism that opens the patch. The Kugel patch is made of two pieces of mesh that surround a flexible plastic ring. The Kugel Mesh Patch is folded and is held open by a “memory recoil ring” that allows the patch placed behind the hernia through a small incision. After it is inserted it is supposed to spring open and lay flat and the mesh material serves as a substrate which allows tissue to grow around the hernia.

This memory recoil ring can break when placed in the abdominal space or migrate to a different location than intended.

Topic Quick Look

Kugel Hernia Mesh Patch Linked to Serious Injuries

What are the risks?

Bowel Perforation - A puncture or opening in the bowel that allows contents of the intestine to leak into the abdomen.
Learn More

Intestinal Fistulae - Abnormal connections or passageways between the bowels, intestines and other organs in the abdomen. Learn More

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