The Bard PolySoft hernia patch is an implantable medical device that is made by C.R. Bard. It is made for certain types of inguinal hernia procedures, but suffers from the same defects that plague many other hernia mesh products. The primary defect in the Bard PolySoft patch is that the plastic mesh is prone to erode and shrink after being implanted. The shrinkage compromises the metal ring that runs along the outside of the PolySoft patch, which can then break and perforate the patient. The erosion can also cause chronic pain and other medical complications, and has been the source of hundreds of hernia mesh lawsuits.
- 1. Bard's PolySoft hernia mesh patch
- 2. Identifying a Bard PolySoft hernia mesh product
- 3. Defects in the Bard PolySoft hernia mesh
- 4. No recalls for the Bard PolySoft
1. Bard's PolySoft hernia mesh patch
The Bard PolySoft hernia mesh patch is a relatively large, flat patch of polypropylene mesh that is shaped like a tear drop. It has a metal ring running along the outside of the device. This metal device lets surgeons fold the device for insertion during a hernia surgery: The metal ring springs the device back into shape once the surgeon releases it.
The PolySoft device was specifically designed for inguinal hernia surgeries that use a preperitoneal incision, higher up on a patient's abdomen, that allows access to the hernia from further back on the patient's body. These surgeries are especially useful for correcting prior hernia surgeries and adding mesh to the inside of the adnominal wall, rather than to the outside of it.
The shape of the Bard PolySoft is designed to fit into this area once surgeons have pulled the hernia back out from the weakened muscles of the abdominal wall. The scar tissue that the mesh is designed to create forms ingrowth between the threads of the mesh. This buttresses the muscles in the abdominal wall to prevent future hernias.
Furthermore, the metal ring along the outside of the PolySoft device allows the procedure to move forward with a smaller incision. The surgeon can fold the PolySoft mesh before pushing it through the incision, letting the device snap back to its original shape once it is released inside the patient's abdomen.
2. Identifying a Bard PolySoft hernia mesh product
The Bard PolySoft hernia mesh has several traits that, taken together, can help patients identify them:
- The PolySoft is irregularly shaped, like a tear drop, to better fit the inside of the abdominal wall,
- It has a metal ring that runs along the outside of the device except for a small section, where it veers inwards on the device, and
- It is larger than most other hernia mesh devices, measuring nearly six inches across.
Bard PolySoft products can also be identified by product number1:
14 x 7.5 centimeters
16 x 9.5 centimeters
3. Defects in the Bard PolySoft hernia mesh
The problems with the Bard PolySoft hernia mesh stem from its extensive use of plastic mesh. This plastic is made from polypropylene, a cheap and common type of plastic that is known to erode and deteriorate when it comes in contact with oxygen. The oxygen in a patient's tissues and blood can trigger this process, causing the plastic mesh to shrink.
When the polypropylene mesh in the Bard PolySoft device shrinks, it puts pressure on the metal ring that encircles the implant, which would not shrink alongside the mesh. The pressure could become great enough for the metal ring to break. This could impale the patient or perforate tissue in their abdominal wall or intestines, causing severe medical complications and pain, and necessitate an emergency procedure.
Even if the metal ring did not break from the mesh's shrinkage, the shrinking PolySoft device would pull on the abdominal wall and any other tissue that had become attached to it. This tension could cause chronic pain and discomfort, especially if the tissue that has ingrown between the mesh's plastic threads contained nerves.
4. No recalls for the Bard PolySoft
Despite the problems that the Bard PolySoft has caused, no recalls have been made for the device. Instead, Bard has quietly replaced it with alternative products.