The Kugel patch was created by Dr. Robert D. Kugel in order to reduce the recovery time of hernia repair surgery and decrease the number of hernias that reappear. Surgery is the only cure for a hernia and over 750,000 hernia repair surgeries are performed in the US each year, mainly to prevent the hernia from becoming a serious health risk and eliminate the pain caused by the hernia. A hernia is when a portion of an organ or tissue protrudes through an abnormal opening in the body. They can develop in the groin, around the navel, or anywhere there is a surgical incision.
The Kugel patch is manufactured by Davol, Inc, which is a division of C.R. Bard. The patch is used to repair Ventral, Inguinal, and Laparoscopic hernias. After insertion through a small incision, the patch is placed behind the hernia defect. The patch is then held open by its “memory recoil ring”, a thin ring that allows the patch to be folded for insertion and spring open, laying flat, once the patch is in place.
The large and extra-large versions of the Kugel patch have been linked to life-threatening side effects and have been recalled by its manufacturer. These versions were recalled because the “memory recoil ring” that opens the patch can break under the stress of being placed in the abdominal area. These breaks have been noted at the point where the ring is welded together.
This defect in the “memory recoil ring” has been found to lead to serious, life-threatening injuries. This breakage can cause bowel perforation, which is when an opening is created in the wall of the intestine, letting the contents of the intestine to flow into the abdominal cavity. Symptoms of a bowel perforation include nausea, vomiting, high fever, and abdominal pain. If the bowel perforation is left untreated, it can lead to sepsis, a blood infection that is nearly always fatal.
The flaw can also cause bowel obstruction, which is the partial or complete blockage of the intestine. This prevents the contents of the intestines from passing through the body normally. The early symptoms of a bowel obstruction include abdominal pain, vomiting, constipation, diarrhea, or bloating. If left untreated, a bowel obstruction can lead to infection, gangrene, or bowel perforation.
Another potentially dangerous side effect of the ring defect is the occurrence of chronic intestinal fistulae, which are abnormal connections between the intestines and other organs. Though some patients with this condition experience no symptoms, in some patients it causes severe abdominal pain. When only one opening of the intestinal fistulae closes, it can cause a cavity in which the bowel contents can accumulate, allowing an abscess or infection to develop. In some cases, this infection can spread to the bloodstream resulting in serious complications.
The US Food and Drug Administration (FDA) have advised patients that have had the large or extra large version of the Kugel patch implanted to seek medical attention immediately if they experience the symptoms associated with ring breakage. These symptoms include fever, unexplained or persistent abdominal pain, tenderness at the site of the implant, or other unusual symptoms. The FDA has received close to one hundred reports of serious adverse events associated with the patch, including severe injuries and deaths. The Kugel patch recall was initiated in December of 2005, and an updated recall list was issued on January 10, 2007. The recall is classified by the FDA as a Class I recall, a category reserved for “dangerous or defective products that predictably could cause serious health problems or death.”
FDA Video: Bard® Composix® Kugel® Mesh Hernia Patch Recall
Below is an excellent video produced by the U.S. Food & Drug Administration (FDA), which warns patients and physicians of the nationwide recall of Composix Kugel mesh hernia patches and provides information about the defective memory recoil ring and possible side effects from ring breakage.
Read the Full Transcript: Bard® Composix® Kugel® Mesh Hernia Patch Recall
Hernia Patch Lawsuit Update: On January 8, 2008, a Federal Court judge expanded the scope of current hernia patch lawsuits to include all Davol/Bard Marlex/Teflon patches, with or without "memory recoil rings."
As early as August 2001, Davol began receiving reports of complications and failures of its hernia mesh patch. These reports advise of bowel obstructions, adhesions, constipation, and fistula resulting from implantation of Composix® Kugel® Mesh Patches. The reports also contain descriptions of problems other then memory recoil ring breakage including, "buckled mesh," "patch shriveling" and "edges curled up," as well as descriptions of the mesh as being "crumpled," "wrinkled," "rolled up," "delaminated" and "folded."