Composix Kugel Mesh Patches
If you have never heard of Kugel mesh, you are not alone. It's not your typical household product, yet thousands of people use it every day. In fact, they walk around with it inside their bodies.
Kugel mesh is a product that, until late 2005, was widely used in surgery to repair hernias. That year, the FDA recalled several versions of the product amid reports that a defect in it had caused serious injuries--including potentially fatal bowel perforation--in some patients.
Before long, other reports of injuries surfaced, and patients began turning to the courts for restitution. Litigation against the manufacturer is progressing--in federal multidistrict litigation (MDL) and in cases in Rhode Island state court--and more problems with Kugel mesh are likely to surface in the future.
If you've never had a hernia, consider yourself lucky. It's a common condition that is attributable to weak stomach muscles. Common causes include excessive straining, chronic constipation, obesity, physical activity, and persistent coughing. When a hernia develops, it creates a gap in the abdominal wall that may allow intestines, fat, or other tissue to protrude through the abdominal lining.
Any section of the abdominal wall is vulnerable, but the most common type of hernia is inguinal, which develops in the groin area. Femoral hernias also develop in the groin but are not as common. An umbilical hernia develops in the navel area, and incisional or ventral hernias occur near prior surgeries.
Hernias are repaired to relieve pain and to prevent strangulation of the intestines or other organs, which can be fatal. According to the American College of Surgeons, nearly half a million people underwent hernia surgery last year.
Surgeons use several repair methods. In the conventional method, the surgeon makes an incision over the site of the hernia, returns the protruding tissue to the abdominal cavity, and removes the sac that formed. The surgeon then repairs the hole or weakness in the abdominal wall by sewing surrounding muscle over the defect.
The laparoscopic method uses a long metal tube with a fiber-optic light source and a telescopic eyepiece, which is connected to a television monitor. This tube is inserted through a small incision and is used to view the hernia while the surgeon repairs it through additional tubes that are inserted through separate incisions by sewing muscle over the defect, as in conventional repair.
The tension-free mesh method does not require surrounding muscles to be stitched together, so it eliminates the strain on these muscles and ligaments and is meant to reduce postoperative pain. Instead, a mesh patch is placed over the hole or weakness, and the pressures of the body hold the patch in place.
Tension-free mesh repair was touted as a superior solution that would allow swift recovery, with a small likelihood of recurrence. But many of the patch materials caused problems with tissue growth. Such growth helps affix the patch and repair the hernia, but it can be dangerous if it impedes, obstructs, or strangulates the bowel, or if it interferes with the function of the underlying organs.
The Kugel mesh patches were recalled because the memory recoil ring, which opens the patch, can break, forming a hard, knifelike object that can slice into and through internal organs. The mesh is supposed to return to its unfolded position, adhere to the stomach lining, and patch the hernia.
The patch failure causes complications such as perforation of the intestines, fistula formation, bowel obstruction, and sepsis. Bowel perforation occurs when bowel contents spill into the abdominal cavity, causing diffuse peritonitis. This results in severe abdominal pain (intensified by movement), nausea, and vomiting.
If you or someone you know has been injured by a Kugel mesh patch call our office today. Our experienced team of attorneys will properly evaluate your case. 619.615.0767
Kugel mesh is a product that, until late 2005, was widely used in surgery to repair hernias. That year, the FDA recalled several versions of the product amid reports that a defect in it had caused serious injuries--including potentially fatal bowel perforation--in some patients.
Before long, other reports of injuries surfaced, and patients began turning to the courts for restitution. Litigation against the manufacturer is progressing--in federal multidistrict litigation (MDL) and in cases in Rhode Island state court--and more problems with Kugel mesh are likely to surface in the future.
If you've never had a hernia, consider yourself lucky. It's a common condition that is attributable to weak stomach muscles. Common causes include excessive straining, chronic constipation, obesity, physical activity, and persistent coughing. When a hernia develops, it creates a gap in the abdominal wall that may allow intestines, fat, or other tissue to protrude through the abdominal lining.
Any section of the abdominal wall is vulnerable, but the most common type of hernia is inguinal, which develops in the groin area. Femoral hernias also develop in the groin but are not as common. An umbilical hernia develops in the navel area, and incisional or ventral hernias occur near prior surgeries.
Hernias are repaired to relieve pain and to prevent strangulation of the intestines or other organs, which can be fatal. According to the American College of Surgeons, nearly half a million people underwent hernia surgery last year.
Surgeons use several repair methods. In the conventional method, the surgeon makes an incision over the site of the hernia, returns the protruding tissue to the abdominal cavity, and removes the sac that formed. The surgeon then repairs the hole or weakness in the abdominal wall by sewing surrounding muscle over the defect.
The laparoscopic method uses a long metal tube with a fiber-optic light source and a telescopic eyepiece, which is connected to a television monitor. This tube is inserted through a small incision and is used to view the hernia while the surgeon repairs it through additional tubes that are inserted through separate incisions by sewing muscle over the defect, as in conventional repair.
The tension-free mesh method does not require surrounding muscles to be stitched together, so it eliminates the strain on these muscles and ligaments and is meant to reduce postoperative pain. Instead, a mesh patch is placed over the hole or weakness, and the pressures of the body hold the patch in place.
Tension-free mesh repair was touted as a superior solution that would allow swift recovery, with a small likelihood of recurrence. But many of the patch materials caused problems with tissue growth. Such growth helps affix the patch and repair the hernia, but it can be dangerous if it impedes, obstructs, or strangulates the bowel, or if it interferes with the function of the underlying organs.
The Kugel mesh patches were recalled because the memory recoil ring, which opens the patch, can break, forming a hard, knifelike object that can slice into and through internal organs. The mesh is supposed to return to its unfolded position, adhere to the stomach lining, and patch the hernia.
The patch failure causes complications such as perforation of the intestines, fistula formation, bowel obstruction, and sepsis. Bowel perforation occurs when bowel contents spill into the abdominal cavity, causing diffuse peritonitis. This results in severe abdominal pain (intensified by movement), nausea, and vomiting.
If you or someone you know has been injured by a Kugel mesh patch call our office today. Our experienced team of attorneys will properly evaluate your case. 619.615.0767