Bard Parastomal Patch - Problems & Litigation

The Bard Parastomal Patch is an implantable hernia mesh made by the medical device manufacturer C.R. Bard. It is used to treat a parastomal hernia, a type of incisional hernia. However, the plastic mesh in the Bard Parastomal Patch has a tendency to erode inside the patient, causing chronic pain and medical complications. Numerous recipients of the device have brought a hernia mesh lawsuit.

bard logo

1. What is the Bard Parastomal Patch?

The Bard Parastomal Patch is an oval-shaped implant that is used to treat and repair incisional hernias involving a stoma. A stoma is a surgically-created hole through the skin and into the abdomen or other internal organ. There are two types of stoma:

  • An ileostomy, which diverts waste from the small intestine and out through the stoma into a collection bag after colon surgery, and
  • A colostomy, which diverts waste from the colon, through the stoma, and into a collection bag after rectal or colon surgery.

In some cases, the creation of the stoma in a patient's outer tissues and skin weakens the muscles in the area enough that tissues from inside push through them near the site of the stoma.

In order to treat parastomal hernias, the Bard Parastomal Patch has two different sides:

  • The side facing the hernia location is covered with a plastic mesh made of polypropylene, and
  • The side facing away from the hernia location and towards the inside of the patient's skin is made of a smooth plastic fiber called expanded polytetrafluoroethylene, or ePTFE.

Near the middle of the device is a small hole that allows continued access through the stoma. A tear from the outside of the patch to this hole allows it to be placed without removing any tubes.

2. How to identify a Bard Parastomal Patch

Bard Parastomal Patches are identifiable from the following traits:

  • They have a cloth-like fibrous layer on one side, and a plastic mesh on the other,
  • They are oval-shaped, rather than circular, and
  • They have a hole for the stoma near the middle of the device and at the end of a tear in the implant's edge, forming a “keyhole” shaped opening.

Depending on the size of the device and the stoma opening, Bard Parastomal Patches have the following product IDs1:

Size of Stoma Opening

Size of Device

Product ID

28 – 35 millimeters

12.5 x 15.5 centimeters

0118001

35 – 45 millimeters

12.5 x 15.5 centimeters

0118002

28 – 35 millimeters

15.5 x 20.5 centimeters

0118003

35 – 45 millimeters

15.5 x 20.5 centimeters

0118004

3. Why the Bard Parastomal Patch is defective

The Bard Parastomal Patch is defective because it uses mesh made of polypropylene plastic. Polypropylene plastic deteriorates, erodes, and shrinks when it comes in contact with oxygen, including the oxygen in a patient's tissues and blood.

Additionally, the ePTFE also deteriorates and shrinks when it is implanted inside the body, but at a different speed than the polypropylene mesh.

The result is a medical device that is designed to create scar tissue and ingrowth in the mesh, but then constricts over time. The mesh's constriction creates a tugging on the tissues it has adhered to, leading to chronic pain and discomfort. The ePTFE's constriction can compromise the stoma and create medical complications.

According to one medical study, 30% of parastomal surgeries using the Bard Parastomal Patch had a postoperative complication within one month. Nearly a quarter of patients who had the Bard Parastomal Patch implanted needed another surgery within the year, and 22% had another hernia in that amount of time.2

4. No recall for Bard Parastomal Patch

While there was never a recall for Bard's Parastomal Patch, it is no longer used to treat incisional hernias involving stomas. However, numerous hernia mesh lawsuits have been filed over the complications and pain that it has caused.


References:

  1. Bard Parastomal Patch Product Description – 2009.

  2. Näsvall P, Rutegård J, Dahlberg M, Gunnarsson U, Strigård K, “Parastomal Hernia Repair with Intraperitoneal Mesh,” Surgery Research and Practice (October 2017).

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