What You Need to Know About the Kugel Hernia Patch

The Kugel Hernia Patch was designed for use in open ventral hernia repair. The patch was used to help eliminate the tension and strain on surrounding muscles and ligaments, which reduced discomfort after surgery.

What Does the Kugel Patch Do?

The Kugel patch is designed to be inserted through a small incision. Once inserted correctly, the patch is supposed to lie flat against the abdominal wall, which helps reduce the number of sutures required. The patch helps the hernia to close and the tissue to heal.

The patch, also known as The Kugel Composix mesh patch, holds a small plastic ring embedded in the patch that allows it to be folded over. The ring is known as the memory recoil ring. Once the ring is in the abdomen, it is deployed.

FDA and Kugel Patch Recall

On December 22, 2005, the FDA (United States Food and Drug Administration) ordered an immediate recall of the Kugel Hernia patch. The recall was due to a reasonable probability that the patch could cause serious health concerns or even death. Several symptoms could be experienced if such a break in the memory coil ring should occur. Symptoms such as:

  • Abdomen pain
  • Fever
  • Sensitivity at the implant site

If you are experiencing any of these symptoms or any other unusual symptoms after surgery, you should consult with your doctor immediately.

What Are the Possible Problems of the Kugel Patch?

Problems with the Kugel Hernia patch are that the memory recoil rings are breaking while the patch is in a patient. This leads to several painful and harmful consequences:

  • Adhesions between intestinal organs
  • Abdominal wall punctures
  • Bowel perforations
  • Fistulae between intestinal organs
  • Abdominal wall tears
  • Abnormal connections between intestinal organs

The breaks can be caused by the stress of the placement of the patch under the abdominal space. These complications may require surgery or, at the very least, additional medical treatment.

More details about the problems of the Kugel Patch

Here is a more specific look at some of the possible problems you could experience if a memory recoil were to break:

Bowel Perforations

Bowel perforation is when an opening forms in the intestinal wall. The contents may flow into the abdominal cavity. This is usually caused by injury, illness, and bowel obstruction. Some patients have experienced bowel perforations due to the breaking of the memory recoil ring, which then can migrate through the abdominal wall.

Symptoms of bowel perforation include:

  • High fever
  • Abdominal pain
  • Nausea and vomiting

Failure to treat bowel perforation promptly can lead to sepsis (a blood infection).

Bowel Obstructions

A bowel obstruction is when there is a complete or partial blockage in the intestines that does not allow the intestinal contents to pass through. Symptoms of bowel obstructions can include:

  • Abdominal pain
  • Constipation
  • Bloating
  • Vomiting or diarrhea

Bowel obstructions can be caused by:

  • Hernias
  • Medication
  • Scar tissue
  • Tumors
  • Twisted intestines
  • Gallstones
  • Foreign objects (this includes the Kugel Hernia Patch)

If not treated quickly, bowel obstructions can lead to bowel perforation, gangrene, or infection.

Chronic Enteric Fistulas

A chronic enteric fistula is an abnormal connection between two parts of the intestine. Occasionally, one fistula opening closes while others remain open; this results in an accumulation of bowel contents in the cavity. When this happens, an abscess or infection may develop, which can spread to the bloodstream. There are few severe symptoms for chronic enteric fistulas, but the most common is significant abdominal pain.

If you experience any form of abdominal pain after a hernia surgery that requires the Kugel Hernia patch, consult with your doctor immediately.

The Kugel hernia patch side effects can be severe, and you should seek legal help if you or a loved one have suffered due to taking this medication. Please call our law firm today at (916) 921-6400 or (800) 404-5400. 

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