The Bard® Composix® Kugel® Mesh Patch with the patented “memory recoil ring” was involved in a Food and Drug Administration Class 1 recall because the plastic memory ring in certain models can break leading to serious patient injury and potentially death.
What Causes Injuries
The Kugel patch is two layers of a mesh fabric with a thin plastic ring sewn in between. The patch is used to repair a hernia by placing it inside the abdomen on the interior side of the weakened abdominal muscle. The patch prevents internal organs from bulging through the weak point in the abdominal wall and stimulates the growth of new tissue to heal the hernia.
To implant the patch, the surgeon folds and inserts it through a very small incision in the abdomen. When he releases the patch, the plastic ring causes the patch to unfold to its full size and provides a slightly rigid structure that allows the surgeon to maneuver the patch into its final position.
In 2002, the manufacturer, Davol, Inc., introduced large and extra large sizes of the patch for repairing incisional hernias. Incisional hernias occur at the sight of prior abdominal surgeries where scar tissue becomes weak, and are commonly larger than other hernia types.
Davol designed the larger patches with a larger gauge plastic ring, but did not change its manufacturing process involving welding the ends of a long plastic rod together to form the ring. After being folded to insert in the abdomen, the weld in the larger gauge rings had the potential to break, leaving two sharp ends of a curved plastic rod inside the patient. This in fact happened in the case of at least 80 patients out of more than 50,000 patches that had been implanted.
Broken Recoil Ring Symptoms
When the recoil ring inside the patient is broken, the patient’s ordinary daily movements can cause one end of the plastic rod to begin poking through the mesh fabric. Continued movement can cause the rod to start migrating elsewhere in the body – potentially in any direction. As the rod migrates further, it eventually begins to puncture abdominal tissue or organs resulting in various types of injuries.
According to the FDA’s recall notice and letters from Davol to hospitals and surgeons, signs of a broken recoil ring include:
- Unexplained or persistent abdominal pain
- Fever or infection
- Tenderness at the implant site
- Bowel obstruction or perforation
- Intestinal fistula
Pain is probably the number one symptom. Hernia surgery using a mesh patch is much less painful than open surgery, but there will still be some degree of pain for several days to a week following the operation. Extreme pain, or pain that remains persistent for more than a week after the incision should have healed may indicate a broken ring moving around inside the abdomen.
Fever, Redness, or Tenderness
If the broken ring manages to puncture an intestine, this can lead to many serious problems, including potentially fatal infection. Fever and redness in the area of the hernia may be signs of such an infection.
Remember that the location of the incision is not necessarily where the patch is. The surgeon normally makes his incision off to the side of the hernia, and pushes the patch into place under the hernia from there. So fever and redness may be somewhere other than near the incision.
Also be aware that some patches may be as large as 10 inches by 13 inches with the ring being on the outer edge. That means the broken end of a plastic ring could be 6 inches away from the hernia, and even farther away from the site of the incision. Therefore tenderness that may occur at the location of the broken end of the ring could be somewhere other than near the hernia or incision.
Bowel Obstruction or Perforation
Because the broken ring can relocate itself, it may interfere with the intestines in any of several ways resulting in an obstructed or perforated bowel. Bowel symptoms may include chronic constipation or diarrhea, or bloody bowel movements. Signs of infection may include fever, redness and tenderness. Any such symptoms following hernia surgery should be reported to your doctor right away.
Fistulas are abnormal ducts or passageways that connect one hollow organ or body cavity to another or to the body’s surface. An intestinal fistula may connect one part of the intestine to another, or the intestine to a body cavity or the skin surface. Fistulas are often associated with infection and abscesses, therefore those will be the symptoms to look for.
Of course, any of the above symptoms can also be signs of something other than a broken memory recoil ring. To determine for certain if the symptoms are Kugel patch related, your doctor will obtain X-rays or CT scans to locate the plastic ring and determine if it is still in place and intact, or if it has broken and begun migrating.