Bard Modified Kugel (MK) Patch - Key Information

The Bard MK Patch, also known as the Modified Kugel Patch, is an implantable medical device used in inguinal hernia procedures. It was made by C.R. Bard. While the MK Patch was designed to update Bard's problematic Kugel Hernia Patch, the Modified Kugel Patch was plagued with many of the same problems of its predecessor. Chief among them was a tendency for the plastic mesh to erode and shrink, causing the metal ring inside the patch to break and potentially impale the patient. Failure of the device has led to serious complications for patients, many of whom have filed a hernia mesh lawsuit

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1. What is Bard's Modified Kugel Patch?

The Bard Modified Kugel Patch was a circular shaped hernia mesh implant with a metal ring inside of it. The Modified Kugel Patch also had mesh straps that could be used to more easily reposition and manipulate the patch, once it had been implanted.

All of the mesh – both the straps and the mesh that made up the rest of the circular implant – was made of polypropylene, a common type of plastic.

The Modified Kugel Patch was primarily used for inguinal hernias. These hernias involve intestinal tissues pushing through weakened muscles in the abdominal wall and into the inguinal canal where the spermatic cord is located in men. Depending on the size and location of the hernia, an inguinal hernia can cause infertility.

The Bard Modified Kugel Patch was designed to treat these hernias. Surgeons could make a small incision near the patient's groin and push the hernia back through the abdominal wall into the intestinal area. The surgeon could then fold the MK Patch and insert it through the incision. Once inside, the surgeon could release the patch and the metal ring would spring it back to its original shape. The surgeon would then use the mesh straps on the back of the Modified Kugel Patch to manipulate it to cover the spot of the hernia.

Over time, the tissues in the abdominal wall would grow into the mesh. The mesh's additional support would keep the intestinal tissues from creating another hernia.

2. How to identify Bard's Modified Kugel Patches

There are several ways to tell if the hernia mesh used in your surgery is a Bard Modified Kugel Patch:

  • MK Patches are circular, not oval,
  • They use a metal ring sewn into the mesh, and
  • A mesh strap runs across the diameter of the patch.

The Bard MK Patch also has the following product IDs, depending on the size, shape, and features of the device1:

Shape and Features

Size

Product ID

Circular with straps

7.5 centimeter diameter

0115808

Circular with straps

10 centimeter diameter

0115810

Circular with straps

11.5 centimeter diameter

0115812

Oval with straps

8 x 12 centimeters

0115814

Oval with straps

9.5 x 13 centimeters

0115816

While the Bard Modified Kugel Patch was never recalled, Bard stopped using them in the 2000s when it released another updated device, the Bard Composix Kugel.

3. Why the Bard MK Patch is defective

The Bard Modified Kugel Patch is defective because it relies heavily on a mesh of polypropylene plastic threads. Polypropylene is a type of plastic that oxidizes, or deteriorates when it comes into contact with oxygen. Because a patient's tissues and blood all carry oxygen, hernia mesh that is made from polypropylene disintegrates over time, even if it is treated with antioxidant additives.

When polypropylene erodes, it shrinks. With the Bard Modified Kugel Patch, the shrinkage puts pressure on the metal ring inside the patch. When that pressure builds, it can break the metal ring, which can then impale the patient.

Additionally, the Bard MK Patch had polypropylene mesh on both sides of the device. The whole point of the mesh was to rub up against the abdominal and create scar tissue that would strengthen the muscles there. However, the mesh on the other side of the device would rub against other tissues and create scar tissue there, as well. When this happened to the patient's bowels, it could create chronic pain.

4. No recalls for the Bard MK Patch

While there was never a recall for the Bard Modified Kugel Patch, Bard no longer uses the device in hernia procedures, having discontinued its use in favor of the newer Bard Composix Kugel device. However, those who have had the Modified Kugel Patch have filed hernia mesh lawsuits against C.R. Bard for the pain and complications that it has caused.


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