The Kugel Patch is designed to help repair hernias, but can move into other areas of the body, causing serious and life-threatening complications. Many patients have sued C.R. Bard, the Kugel mesh manufacturer, after their patches moved and caused bowel obstructions and abdominal punctures.
The Kugel Hernia Patch is a brand-name surgical mesh used to repair hernias. A hernia occurs when an abdominal organ, fatty tissue or intestine breaks through a weakened area in the surrounding muscle or connective tissue. Most hernias occur at the abdominal wall (ventral), but can also occur in the inner groin (inguinal), outer groin (femoral), belly button (umbilical), at an incision or scar site (incisional) and along the diaphragm (hiatal). Surgical mesh — which is often made of synthetic materials or pig or cow skin or intestine — is used to strengthen the weakened or torn tissue.
According to one study from 2014 published in the Journal of the American Medical Association, there are more than 350,000 abdominal hernia repair surgeries in the United States each year. Hernia patches have grown in popularity because, according to the same study, using the mesh leads to a lower hernia recurrence rate than stitching the torn tissue closed because stitches don’t strengthen the weakened tissue. The Kugel Hernia Patch is made by Davol, Inc., a subsidiary of the medical manufacturing giant C.R. Bard.
The implant is named after its developer, Dr. Robert D. Kugel. Kugel patches are synthetic, made from a double layer of monofilament polypropylene. Designed to be used in minimally-invasive laparoscopic procedures, the Kugel patch is folded for insertion before deployed in the body cavity with the help of a memory recoil ring that springs the patch open to its full shape and size.
In some patients, the implant ring has broken or bent, however, causing the implant to move, bowel obstructions, punctures and other complications. The U.S. Food and Drug Administration announced the recall of eight different Composix Kugel patches in 2006 and 2007. Since the recalls, more than 3,000 Kugel patch lawsuits have been filed across the U.S.
Symptoms of Kugel Patch Complications
Although designed to heal patients suffering from painful hernias, many variations of the Bard Composix Kugel Patch have been known to break, causing many serious and potentially life-threatening complications. According to the FDA, patients in more severe cases — especially when the memory recoil ring inside the Kugel patch breaks — have reported side effects like:
- Mesh migration
- Mesh shrinkage
- Unexplained and persistent abdominal pain
- Tenderness at implant site
- Hernia recurrence
- Adhesions, or bands of scar tissue that abnormally connect two organs or tissues together
- Bowel obstruction
- Abdominal or bowel perforation
- Chronic intestinal fistulae, or abnormal connections between two hollow organs
Bowel obstruction and abdominal or bowel perforation are the most common and some of the most dangerous symptoms in the case of a broken memory recoil ring. A bowel obstruction occurs when the small or large intestine is partially or fully blocked, causing nausea, vomiting and the inability to pass gas or stools.
Perforation occurs when the broken ring punctures the bowel, abdominal wall or another abdominal organ. A bowel perforation, also known as an intestinal perforation, allows fecal matter and bacteria to enter the abdominal cavity, causing inflammation (peritonitis). Symptoms of this complication include nausea, vomiting, severe abdominal pain and abdominal rigidity. Intestinal perforation is life-threatening and is considered a medical emergency. Perforation can also cause sepsis, an infection of the blood stream, which is also potentially fatal.
Diagnosis of Kugel Patch Complications
Kugel patch complications can be hard to diagnose because the complications vary widely and could be related to or caused by other conditions. If a patient experiences any of these symptoms and has had a Kugel mesh implant, their doctor should consider the possibility the symptoms are caused by the patch. In the case of an emergency, patients should tell emergency room doctors that they’ve had the Kugel implant.
There are several diagnostic tests doctors can use to detect complications with the Kugel patch, including X-ray, CT scan and a blood test. The blood test may be the most diverse diagnostic test because it can reveal several different problems, including:
- High white blood cell count, which can indicate infection
- Hemoglobin, which can identify blood loss
- Electrolytes, which can reveal a kidney problem
- Enzymes, which can indicate a liver problem
If a doctor suspects bowel obstruction, they may also choose to perform a colonoscopy. During this procedure, the patient receives a sedative before a camera is inserted into the colon. Images from the camera are projected onto a TV screen where the doctor can fully visualize what is obstructing the bowel, such as a Kugel patch.
Kugel Patch Complications and Treatment
Just as diagnosis techniques can vary between complications, treatment also varies. Patients experiencing a bowel or abdominal perforation only have one course of treatment — surgery. The procedure will repair the hole, remove the Kugel patch ring that punctured it and clear the abdominal cavity of any spilled material such as feces, bile or food.
Bowel obstructions can be treated in several different ways, depending on how severe the obstruction is. While many doctors may prefer to wait and see if a partial obstruction resolves on its own, partial obstruction caused by a foreign object may require surgery to remove. Surgery is also the typical course of treatment for a complete obstruction. Alternatively, a doctor may also try to remove the obstruction non-surgically by inserting a stent into the colon to force it open and clear the obstruction.
Depending on the complication, the patient’s surgeon may decide to perform a revision surgery to remove the Kugel hernia patch. Surgery or medication, or a combination of both, may also be used to treat an adhesion and fistula.