Every year, close to 750,000 hernia repair surgeries are performed in the United States. Traditionally, these surgeries were performed as “open” surgeries, requiring a large incision to be cut into the lower abdomen to allow surgeons the access and room for maneuverability that they required for the repair. Today, a minimally invasive procedure named laparoscopic hernia repair surgery is gaining popularity, due to the rapid healing and reduction of pain associated with this type of surgery. Patient are able to return to their normal activities much faster than with traditional “open” surgeries.
Most hernias can be repaired laparoscopically. First, general anesthesia is given and a tiny incision is created in or just below the navel. The abdomen is inflated using air to give the surgeon a better view of the internal organs, and a small, lighted scope, called a laparoscope is inserted in the incision. Instruments to repair the hernia are inserted through other pencil-width incisions in the abdomen. The intestines or organs protruding into the herniated area are put back into their original places and a patch is placed on the weakened area of the abdominal wall. Placing the patch on the inside of the abdomen takes advantage of the natural, outward pressure of the abdomen, securing the repair in place and reducing the chance that the hernia will reoccur.
Laparoscopic hernia repair surgery does have some risks associated with it, the same as any other surgery. Major risks associated with laparoscopic hernia repair surgery include:
- Fluid or blood in the abdominal muscles, scrotum, or inguinal canal
- Inability to urinate
- Pain in the spermatic cord, the testicles, or the thighs
- Infection of the stitches or mesh
- Formation of scar tissue
- Testicular atrophy, a rare occurrence
Recurrence of the hernia occurs in a small percentage of patients undergoing laparoscopic hernia repair surgery, usually related to the mesh patch not staple well enough or the patch being too small to cover the entire herniated area. Laparoscopic surgery is also more expensive due to the increased cost of technology and slightly longer operating room time.
One of the most popular patches for laparoscopic hernia repair surgery is the Kugel Mesh Hernia Patch manufactured by Davol, Inc., a division of C.R. Bard. These patches have a “memory recoil ring” that allows the patches to be folded for insertion into the abdomen, then spring open to complete the repair. In December of 2005, a link was found between the larger versions of the patches and serious side effects, leading to a recall of the devices by the manufacturer. The recall was issued because the “memory recoil ring” can break under the stress of placement in the abdomen, causing bowel obstructions, bowel perforations, and chronic intestinal fistulae, which are abnormal passageways between the intestines and other organs.
To date, the US Food and Drug Administration (FDA) has received close to 100 reports of serious injuries and deaths associated with the implantation of the larger versions of the Kugel Mesh Hernia Patch. The recall is classified as a Class I Recall by the FDA, a class limited to devices that could predictably cause serious health problems or death. Individuals who have had the devices implanted are urged to seek emergency medical attention if a breakage of the Kugel Mesh Hernia Patch is suspected.
Kugel 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."