Kugel Hernia Patch
Imagine fixing a hole in an air mattress by placing a patch on the inside wall of the mattress instead of on the outside.
For patients in need of ventral hernia repair, such a “patch” placed on the inside lining of the torn or separated abdominal wall became an effective treatment of choice in recent years. Ventral hernias occur around incisions from previous surgeries when scar tissue becomes thinned or stretched.
Unfortunately, some patches commonly used by surgeons have proven defective, causing potentially severe and life-threatening injury.
Davol, Inc., a subsidiary of C. R. Bard, Inc. (a medical device manufacturing giant), has expanded an earlier 2005 Class I recall to include specific batches of large and extra large mesh patches under the brand names Bard®, Composix®, and Kugel® manufactured between January 1, 2004 through September 30, 2005.
The patch itself is surrounded by a recoiling “memory” ring, surgically implanted by a procedure that involves folding the ring then inserting it through the torn or stretched tissue, most commonly during a laparoscopic procedure. Once in place, the ring is released and springs to full size, securing the mesh patch like a shield over the affected area.
The device itself became an issue of concern when complaints of broken rings began to surface, both during the implant procedure itself, as well as post-operatively.
Once broken, the ring can puncture the abdominal wall, or migrate causing serious and potentially life-threatening complications, such as bowel perforations and blockages of other gastro-intestinal organs.
In addition to the defective ring itself, the manufacturer is alleged to have provided inadequate training to physicians regarding “folding” procedures prior to insertion, and in some cases, no training at all, which may have contributed to the number of broken rings overall.
Despite what reads as a rather limited few (6) reports of incident on Davol’s website, certainly nothing that would suggest great harm to patients has occurred, families and patients alike around the country cite countless horror stories. Many state chronic and acute infections at the surgical site that were seemingly unaffected by powerful antibiotics; cutting up pampers (diapers) to absorb all the drainage for months at a time; constant pain that went undiagnosed by physicians, and yes, death, mostly attributed to acute infections that slowly ended the life of a loved one.
Patients who have undergone surgical repair a ventral hernia with a mesh patch and develop unexplained abdominal pain, fever or tenderness at the surgical cite should seek immediate medical attention.
For more information regarding the specific recalled product codes and/or to receive information about current legal action being sought against the manufacturer, please contact Horwitz, Horwitz & Associates attorney, Michael Carter at (866) 352-0463 toll free, or email your question to us at Ask an Attorney.
