The Bard 3DMax and 3DMax Light Mesh are implantable hernia mesh products that are made by C.R. Bard. They are frequently used to treat inguinal hernias. Unique aspects about these devices, though, have made them especially dangerous to patients who have had them implanted. Men who have had the 3DMax or the 3DMax Light mesh implanted for an inguinal hernia are especially at risk, as they have suffered chronic pain and even sexual dysfunction when the mesh erodes into the spermatic cord. Once this erosion has happened, removing one of these hernia mesh devices can require removing a testicle, as well.
- 1. What is a Bard 3DMax Mesh?
- 2. How to identify a Bard 3DMax or 3DMax Light mesh
- 3. How the 3DMax Mesh devices can be defective
- 4. No recalls for the 3DMax Mesh devices
1. What is a Bard 3DMax Mesh?
A Bard 3DMax hernia mesh is an irregularly-shaped mesh product that is designed for use in surgeries to treat inguinal hernias. It is made of polypropylene, a popular type of lightweight plastic.
Inguinal hernias happen when the muscles lining the lower abdominal wall are so weak that internal tissues in the intestinal area push through the abdominal wall and into the inguinal canal in the groin. In men, this canal is where the spermatic cord is found. An inguinal hernia can cause complications with the spermatic cord and can even lead to infertility.
The Bard 3DMax Mesh is a product that surgeons use during an inguinal hernia procedure to strengthen the walls of the abdominal wall. After making an incision in the patient’s lower abdomen and pushing the hernia back through to the abdominal wall and out of the inguinal canal, surgeons can cover the hole in the abdominal wall with a Bard 3DMax Hernia Mesh product. The tissue in the abdominal wall then coalesces with the mesh to form a stronger barrier between these two internal regions.
The Bard 3DMax Light Mesh is identical to the 3DMax Mesh, except the Light Mesh is more sparsely knit, lighter, and a slightly different size from the basic 3DMax Mesh.
2. How to identify a Bard 3DMax or 3DMax Light mesh
The Bard 3DMax hernia mesh and 3DMax Light Mesh are identifiable from other hernia mesh products in several ways:
- They are shaped, or contoured, to fit the inguinal canal, with a flat bottom and a curved top,
- They have a blue capital letter M, underlined by an outward-pointing arrow, near one corner of the implant to point towards the patient’s medial, or vertical centerline,
- They have a rim running along the outside of the device, and
- They are curved into a concave shape to cup the abdominal wall in the inguinal canal.
Based on the size of the Mesh and whether it is placed on the right or the left side of a patient’s medial, a particular Bard 3DMax hernia mesh can have the following serial numbers1:
|Left||Medium (3 x 5 inches)||0115310|
|Left||Large (4 x 6 inches)||0115311|
|Left||Extra large (5 x 7 inches)||0115312|
|Right||Medium (3 x 5 inches)||0115320|
|Right||Large (4 x 6 inches)||0115321|
|Right||Extra large (5 x 7 inches)||0115322|
Similarly, 3DMax Light hernia mesh can have the following serial numbers2:
|Left||Medium (3.1 x 5.3 inches)||0117310|
|Left||Large (4.1 x 6.2 inches)||0117311|
|Left||Extra large (4.8 x 6.7 inches)||0117312|
|Right||Medium (3.1 x 5.3 inches)||0117320|
|Right||Large (4.1 x 6.2 inches)||0117321|
|Right||Extra large (4.8 x 6.7 inches)||0117322|
3. How the 3DMax Mesh devices can be defective
The 3DMax and the 3DMax Light hernia mesh products from C.F. Bard have been known to have several different problems:
- The plastic mesh can erode,
- The rim on the outside of the device can break,
- The device can migrate from its original placement, and
- The mesh can curl or fold together.3
3.1 Erosion of 3DMax hernia meshes
Erosion is the most severe defect with the Bard 3DMax device. Because it is made out of polypropylene, a common and inexpensive kind of plastic, the Bard 3DMax hernia mesh implants are prone to deteriorating over time inside the patient’s body. This deterioration process releases potentially toxic material into the patient’s tissues and bloodstream, which can trigger a host of medical complications.
For men, if this erosion continues unabated, it can lead to the 3DMax mesh eroding into their spermatic cord, causing sexual dysfunction. Removing the mesh at this point is nearly impossible, and often requires removing a testicle, as well.
Erosion can also shrink the mesh device. This can pull on the tissues that have grown into it and cause debilitating pain, or can cause the mesh device to tear off the abdominal wall and migrate elsewhere in the patient’s body, causing medical complications wherever it goes.4
3.2 Broken rims on 3DMax hernia meshes
A broken rim on the 3DMax or 3DMax Light mesh can also create serious problems. The rim is designed to keep the weave of the mesh intact and prevent it from fraying. Once the rim has been broken, though, the rest of the mesh device is prone to tearing, fraying, splitting, and deteriorating. This can cause tissue perforation, lacerations, and chronic pain. Some surgeons who have used Bard’s 3DMax or 3DMax Light meshes have found that the rims were already broken when they opened the package to implant them, or broke during the implant procedure.5
4. No recalls for the 3DMax Mesh devices
In spite of the risks that 3DMax and 3DMax Light mesh devices have posed for patients, they have not been recalled. They are, however, the subject of a large number of pending hernia mesh lawsuits.