The Bard Spermatex was an implantable hernia mesh device made by C.R. Bard. It used to be used to treat inguinal hernias, but has since been replaced by other hernia mesh products, like the Bard Pre-Shaped Mesh. Just like with other hernia mesh products, the plastic mesh that comprised much of the Spermatex was prone to erosion after it was implanted. Because the device was designed to create ingrowth and scar tissue that drew the device into a patient's abdominal muscle, this erosion could create chronic pain and other medical complications. As a result, the Bard Spermatex has led to hundreds of hernia mesh lawsuits.
- 1. The Bard Spermatex hernia mesh
- 2. Identifying a Bard Spermatex device
- 3. Defects in the Bard Spermatex
- 4. No recall for the Bard Spermatex
1. The Bard Spermatex hernia mesh
The Bard Spermatex hernia mesh is an implant that was frequently used in inguinal hernias. It was made of plastic mesh and was shaped like a flattened oval, more than twice as wide as it was tall. One of the narrow ends was cut off to end in a straight edge rather than a rounded one. While one face of the other, rounded edge was made of plastic mesh, the other face was covered with a plastic fabric.
The plastic mesh was made of polypropylene, while the plastic fabric was made of ePTFE, or expanded polytetrafluoroethylene.
The Bard Spermatex's design was for use in inguinal hernia surgeries. These hernias involved intestinal tissue pushing through weakened muscles in the abdominal wall and into the inguinal canal. In men, this canal was where the spermatic cord was located, so inguinal hernias presented a risk of causing infertility.
The shape of the Bard Spermatex was designed to find this inguinal canal, where it could join the abdominal wall and create scar tissue to strengthen the muscles there. The ePTFE fabric on one side of the device was designed to prevent scar tissue from building up around the spermatic cord and creating complications.
2. Identifying a Bard Spermatex device
A Bard Spermatex is a precursor to the Bard Pre-Shaped Mesh. You can identify a Spermatex device from the following traits:
- It is shaped like a flattened oval or a “thumbnail,” with the diameter going from 2.4 inches to 5.6 inches,
- One of the narrow ends has been cut off into a straight edge,
- That other, rounded edge of the device has a plastic fabric substance coating one face, while the other face is made of plastic mesh, and
- The device does not have a hole in the middle of the device, nor a tear from the straight edge to that hole, forming a “keyhole” shape (implants with this keyhole shape are likely a Bard Pre-Shaped Mesh, which eventually replaced the Bard Spermatex).
The Bard Spermatex was sold at least until 2012 under the product number 0114700.1
3. Defects in the Bard Spermatex
The Bard Spermatex was defective because it relied on plastic mesh made of polypropylene, a common and cheap material that deteriorates when it comes in contact with oxygen. Even when polypropylene is coated with antioxidant additives, it still erodes over time when in constant contact with the oxygen in a patient's blood and other tissues.
Unfortunately, the whole point of using mesh in hernia implants is to create scar tissue that grows into the space between the mesh's threads, connecting the mesh to the muscles in the abdominal wall. While this strengthens the muscles by creating more tissue, when the mesh deteriorates and shrinks, it tugs on the tissue it has created, creating discomfort. If nerves have formed in the scar tissue, this pulling can cause chronic pain.
Additionally, the ePFTE fabric also deteriorates in oxygen, but at a different rate than the polypropylene mesh. The different rates of erosion can twist and deform the device, making it tug more on the tissues of the abdominal wall.
4. No recall for the Bard Spermatex
The Bard Spermatex was never recalled. Instead, it was slowly and quietly replaced by other hernia mesh devices, like the Bard Pre-Shaped Mesh.