The Bard Kugel Patch was an implantable medical device that used to be used to treat inguinal hernias. It was manufactured by C.R. Bard, but was phased out during the 2000s with the introduction of the Bard Modified Kugel Patch, which was also known as the MK Patch. The plastic mesh that made up the older Bard Kugel Patch was known to erode after implantation in a patient. This erosion shrunk the patch, causing medical complications and chronic pain. The shrinkage also compromised the strength of the metal ring inside the patch, which could break and impale the patient if not corrected. The problems with the Bard Kugel Patch have spawned numerous hernia mesh lawsuits.
- 1. The Bard Kugel Patch
- 2. Identifying the Bard Kugel Patch
- 3. Defects in the Bard Kugel Patch
- 4. The Bard Kugel Patch was never recalled
1. The Bard Kugel Patch
The Bard Kugel Patch was one of Bard’s earliest iterations of a hernia mesh product. It was little more than an oval or circular shaped mesh of polypropylene plastic. A collapsible metal ring was sewn between two of the layers of the plastic mesh. This metal ring allowed the device to be folded for insertion during a surgery. Once inside and released, the metal ring would spring the device back to its original shape, covering more area.
The Kugel Patch was used for inguinal hernias, or bubbles of intestinal tissues that burst through weakened muscles in the abdominal wall and into the inguinal canal. These hernias are especially common, and especially problematic, for men: The spermatic cord is located in the inguinal canal in men. If the hernia is large or in the wrong place, it could compromise the spermatic cord and cause infertility.
The Bard Kugel Patch was meant to treat these hernias. By pushing the hernia back through the abdominal wall and then inserting the patch on the hernia location through an incision in a patient’s groin, a surgeon could induce scar tissue that, together with the mesh, supported and strengthened the muscles there.
The size of the incision was reduced by the metal ring in the Kugel Patch. A surgeon could fold the patch before insertion, and the metal ring would spring the patch back to its original size and shape once released.
2. Identifying the Bard Kugel Patch
While the Bard Kugel Patch is rarely used, anymore, thousands of people with hernias have had them implanted in the past. For these patients, there are several ways to tell if your hernia device is a Bard Kugel Patch:
- It is either circular or oval shaped,
- There are no straps of mesh running across the device’s diameter (if there is, it is likely a Bard MK Patch),
- There is a metal ring inside the layers of plastic mesh that make up the device, and
- There is no plastic fabric layer on one side of the device (if there is, it is likely a Composix E/X or Composix Kugel device).
Depending on the size and shape of the device, Bard Kugel Patches have the following product numbers1:
|Oval||8 x 12 centimeters||0010101|
|Oval||11 x 14 centimeters||0010105|
|Oval||14 x 18 centimeters||0010102|
3. Defects in the Bard Kugel Patch
The reliance of the Bard Kugel Patch on polypropylene plastic is what makes it defective and prone to hurt people.
Polypropylene is a common and cheap type of plastic that oxidizes, or deteriorates when it comes into contact with oxygen. Because your blood and tissues contain oxygen, the use of polypropylene in implantable medical devices – even if the plastic is treated with an antioxidant – is a terrible design decision.
Nearly the entire Bard Kugel Patch is made of polypropylene plastic mesh. As the mesh deteriorates and erodes, it tugs on the tissues that it touches and the ingrowth that it has developed since being implanted. This causes chronic pain, particularly if nerve endings have formed in the ingrowth. If the device erodes enough, it can tear off the abdominal wall, creating serious medical complications, and migrate elsewhere in the body.
Additionally, the shrinkage of the Bard Kugel Patch strains the metal rings that is sewn inside of it. This ring does not shrink along with the mesh that surrounds it. When the pressure of the collapsing mesh reaches the ring’s breaking point, it can snap and puncture the patient’s abdominal wall or other tissues.
Finally, the Bard Kugel Patch proved to be a difficult device for surgeons to successfully implant. After release, the metal ring frequently failed to fully spring the patch back to its original, flat shape inside the patient’s inguinal canal. Precisely because of the smaller incision used in the procedure, surgeons struggled to right the problem. Additionally, if the Bard Kugel Patch was not implanted immediately in the right location, surgeons found it difficult to maneuver or correct. As a result, many inguinal hernia procedures using the Bard Kugel Patch were poorly done because the mesh device would be in the wrong place or were folded on itself in ways that the surgeon could not correct.
Bard’s Modified Kugel device – the hernia mesh product that replaced the Bard Kugel Patch – came equipped with mesh straps on its backside that allowed surgeons to move it and manipulate it after implantation through the incision.
4. The Bard Kugel Patch was never recalled
In spite of the numerous issues with the Bard Kugel Patch and the hundreds of patients who have been hurt by it, neither Bard nor the U.S. Food and Drug Administration (FDA) have recalled the device. Instead, it was quietly replaced by the Bard Modified Kugel Patch, which was subsequently replaced in favor of the Bard Composix Kugel device.