The Bard Pre-Shaped Mesh is an implantable hernia mesh product that is made by the company C.R. Bard. They are designed and shaped specifically for use in inguinal hernias, though in practice this design is less than perfect. Moreover, Bard Pre-Shaped Mesh products have been known to erode, fray, or deteriorate while inside a patient’s body, causing chronic pain and debilitating medical complications.
- 1. What is Bard Pre-Shaped Mesh?
- 2. How to identify Bard Pre-Shaped Mesh
- 3. How Bard’s Pre-Shaped Mesh can be defective
- 4. No recalls for Bard’s Pre-Shaped Mesh devices
1. What is Bard Pre-Shaped Mesh?
Bard Pre-Shaped Mesh is an irregularly-shaped mesh product that is designed to be implanted to treat inguinal hernias. In some Pre-Shaped Mesh products, one end of the mesh is split to the middle of the mesh where there is a small hole. The tear and the hole form a “keyhole” that is meant to accommodate the spermatic cord in the inguinal canal. Like most other hernia mesh products made by C.R. Bard, the Pre-Shaped Mesh is made of polypropylene, a common type of plastic.
Inguinal hernias are medical conditions that involve tissues in the intestinal area to push through weakened muscles that line the lower abdominal wall and into the inguinal canal in the groin. This canal is where a man’s spermatic cord is located. Depending on the size of the hernia, surgery can be necessary to prevent infertility.
The Pre-Shaped Mesh by Bard is a medical device that surgeons can implant in a patient as a part of an inguinal hernia surgery. After making an incision in the patient’s lower abdomen, the surgeon pushes the herniated tissues out of the inguinal canal and back through the abdominal wall. After doing this, the surgeon can use one of Bard’s Pre-Shaped Mesh products to cover the hernia hole in the abdominal wall.
The mesh is designed to create enough scar tissue in the abdominal wall to fill the holes in between the mesh’s weave. Combined with the extra support of the mesh, this scar tissue increases the strength of the abdominal wall that had been weak enough to permit the hernia.
2. How to identify Bard Pre-Shaped Mesh
Bard Pre-Shaped Mesh is different from other hernia mesh products in several ways:
- It is shaped like a flattened oval, more than twice as wide as it is tall,
- One of the narrow ends of the oval is cut off, ending in a straight edge rather than a rounded one, and
- It can have a hole near the middle of the mesh and a tear from the straightedge that reaches all the way to the hold in the middle, forming a keyhole shape.
The size of the mesh and whether there is the keyhole cutout determine the product’s ID1:
| Size | Keyhole | Product ID |
| Normal (1.8 x 4 inches) | No | 0112700 |
| Normal (1.8 x 4 inches) | Yes | 0112710 |
| Large (2.4 x 5.4 inches) | No | 0113700 |
| Large (2.4 x 5.4 inches) | Yes | 0113710 |
3. How Bard’s Pre-Shaped Mesh can be defective
Bard’s Pre-Shaped Mesh devices for inguinal hernias have been known to have several defects that can cause severe pain and discomfort:
- The mesh can migrate away from its original placement,
- The plastic in the mesh can erode, and
- The mesh can fold.
Out of all of the problems that Bard’s Pre-Shaped Mesh devices can have, erosion is likely the most common and the most severe. Because the mesh device is made of polypropylene, a common type of plastic that deteriorates when it comes in contact with oxygen, Bard Pre-Shaped Meshes can release toxic material into the surrounding tissues and bloodstream over time. The deterioration of the polypropylene also shrinks the device, causing it to tug on the abdominal wall. This can cause serious and chronic pain, and can cause the device to separate from the abdominal wall and migrate.
In the most severe cases, and in spite of the keyhole shaped cutout that was designed to accommodate the spermatic cord, the deterioration of the plastic in the Bard Pre-Shaped Mesh can cause the device to erode into the spermatic cord. If not corrected quickly, the scar tissue this creates can lead to infertility, and can become so severe that the device cannot be removed without also removing a testicle.
4. No recalls for Bard’s Pre-Shaped Mesh devices
Despite the risks of Bard’s Pre-Shaped Mesh devices to patients who have undergone an inguinal hernia surgery, there have still not been any serious recalls of the device. There are, however, numerous hernia mesh lawsuits against C.F. Bard for the defective products that they have made.
Legal References:
- Bard Pre-Shaped Mesh Product Description.