First introduced in 1997, the Bard Composix Kugel Mesh Hernia Patch is a type of prosthetic intended to treat the ventral hernia, a condition in which an organ in the abdomen pushes through a weakened abdominal wall. At the time, the Kugel Mesh Hernia Patch was revolutionary in its method of treating hernias.

However, because these mesh hernia patches started malfunctioning and causing serious injuries, the Food and Drug Administration (FDA) has issued three separate recalls, the first in 2005, the second in 2006 and the third in 2007.

While the FDA has mandated that medical professionals stop using Kugel Mesh Hernia Patches, many patients have suffered (or will suffer) health complications from these devices, which have already triggered a flood of personal injury lawsuits against the Bard company and its subsidiary Davol, Inc.

How Does the Kugel Mesh Hernia Patch Work?

The Kugel Mesh Hernia Patch is made up of two pieces of mesh fabric that sandwich a flexible plastic ring, known as the “memory recoil ring.” To insert the patch, surgeons:

  • Make a small incision near the site of the hernia.
  • Bend the mesh hernia patch to fit it through the incision.
  • Move the bent mesh patch to the hernia site.
  • Release the bent plastic ring so it recoils to its natural position (in which the patch is flattened).

With the Kugel Mesh Hernia Patch in place, the weakened abdominal wall is given support, as the patient’s own tissues continue to grow and heal the hernia.

Kugel Mesh Hernia Patch: Defects and Recall

Unfortunately, the Kugel Mesh Hernia Patch’s plastic ring – the same ring that is key to its insertion and proper functioning – can break and seriously harm patients. In addition to the internal bleeding that may occur when a broken ring cuts internal organs, patients with a malfunctioning mesh hernia patch may also suffer from:

  • bowel obstructions, preventing patients from emptying the contents of their intestines
  • bowel perforations, causing intestinal contents to leak into the abdominal cavity
  • chronic intestinal fistulae, an abnormal intestinal connection
  • death

To date, the FDA has recorded over 80 cases of injuries that have resulted from defective mesh hernia patches.

Patients with a Kugel Hernia Patch will likely experience some of the following symptoms with a break or malfunction in the patch:

  • abdominal pain
  • constipation
  • fever
  • nausea
  • tenderness at the site of the incision
  • vomiting

Seek immediate medical attention if you currently have a Kugel Mesh Hernia Patch and start experiencing any of the above symptoms.

New York Times Exposé: Davol Knew About Patch Defects

Although the FDA’s mesh hernia patch recalls started in 2005, a groundbreaking article published in the New York Times (in 2007) proved that Davol had been receiving patient complaints regarding the Kugel Mesh Hernia Patches as early as 2002. While Davol first attributed patch defects to improper insertion methods, by the end of 2005, the company realized that the patch itself was faulty. This, along with evidence of Davol’s mishandling of patients’ complaints, has served as strong evidence in personal injury lawsuits against both Davol and Bard.

Because there is evidence that Davol knew about patch defects long before the first recall in 2005, anyone who has suffered health complications as a result of mesh patch defects should consult a personal injury lawyer who specializes in Kugel Mesh Hernia Patch lawsuits.

The problems resulting from mesh hernia patches can be devastating; however, pursuing a personal injury claim can get you the compensation you need to restore your health.

Contact us today to learn more about your legal options.

Published November 17, 2011 by