Bard-Kugel Hernia Repair
What is the Bard-Kugel Mesh Patch?
The Bard-Kugel Mesh Patch is a medical device manufactured by Bard and Kuger and was approved for use in the United States by the Food and Drug Administration (FDA) in 1996.
The Bard-Kugel Mesh Patch is surgically implanted via a small incision, and is put in to help heal hernias. It is positioned behind the hernia and the “memory coil ring” opens up the Bard-Kugel Mesh Patch behind the hernia. At this stage the patch is supposed to assist in repairing the hernia suffered by the patient.
The most common patients to receive the Bard-Kugel Mesh Patch are women who have had cesarean sections, patients whom have had abdominal surgery, or those with weak abdominal muscles. A hernia is an abnormal gap in the abdominal wall allowing organs and tissues to protrude out through the abdominal lining.
There have been multiple Bard-Kugel Mesh Patch recalls since the year it was introduced to the market. The FDA issued its first recall in 2005, and again in both 2006 and 2007, and recalled certain models of the patch after multiple reports of the “memory coil ring” had broken inside a number of patients. The ring breaking inside of patients has led to of painful and serious injuries and the FDA classified the certain models in the recall as Class 1. This level recall is reserved for products that pose a serious health risk to the public and can cause death.
Bard-Kugel Mesh Patch Side Effects
Potential side effects of the Bard-Kugel Mesh Patch include;
- Unexplained or Persistent Abdominal Pain
- Tenderness at Surgery Site or Other Unusual Symptoms
- Bowel Perforation
- Intestinal Fistula
- Abdominal Abscess Formation
Bard-Kugel Mesh Patch Litigation
According to The Providence Journal, Bard-Kugel has agreed to pay $184,000,000 to settle 2,600 of the 3,600 cases filed against it due to complications with the patch. The lawsuits allege that the patch causes serious medical complications including bowel perforation, sepsis, intestinal fistulas and abdominal abscess formation.
At the time of the first recall in 2005, over 32,000 Bard-Kugel Mesh Patches had been used worldwide, and sales in 2005 alone reached over $11,000,000. Today thousands of cases are pending against these major companies, with many more to be filed.
At Sheff Law, we are the Massachusetts law firm with the resources, experience, and national reputation to investigate injuries resulting from exposure to the Bard-Kruger Mesh Patch. Patients across Massachusetts and America are starting to realize some of the potential harmful consequences of using the Bard-Kruger Mesh Patch to repair the hernia. If you or a loved one has been injured as a result of the Bard-Kruger Mesh Patch, contact an attorney at Sheff Law today by filling out a FREE consultation form, or call at (888) 423-4477 or 617-227-7000.
February 23rd, 2016 | Posted in Blog