The Covidien Parietex is a series of hernia mesh devices that is manufactured by Covidien, a subsidiary of Medtronic. Unlike many other hernia mesh devices, the Parietex line of products uses polyester mesh, rather than plastic mesh. However, they still have serious defects that have caused discomfort, chronic pain, and other injuries in patients who have had a Parietex device implanted. Numerous hernia mesh lawsuits have been filed, as a result.
- 1. The Covidien Parietex line of hernia mesh implants
- 2. Why Covidien Parietex implants are defective
- 2.1 Some Covidien Parietex devices are difficult to implant
- 2.2 The polyester in Parietex implants creates high levels of inflammation
- 2.3 The polyester in Covidien Parietex devices shrinks after implantation
- 2.4 Shrinking polyester tears away from tissue and migrates
- 2.5 Unsealed edges on Parietex devices can perforate tissue and organs
- 3. No recall for Covidien Parietex products
1. The Covidien Parietex line of hernia mesh implants
The Covidien Parietex is a whole line of hernia mesh products, each with its own special purpose or design. Models include the Parietex:
- Composite Ventral Patch,
- Composite Hiatal Mesh,
- Composite Open Skirt Mesh,
- Composite Parastomal Mesh,
- Optimized Composite Mesh,
- Optimized Open Skirt Mesh,
- ProGrip Self-Fixating Mesh,
- EaseGrip Mesh,
- Plug and Patch System, and
- Lightweight Monofilament Mesh.
Each product is designed to be used in hernia surgeries.
Once the surgeon has corrected the hernia, they can implant any of Covidien's Parietex devices at the location of the hernia. The implant is designed to create scar tissue that grows into the pores of the device. The scar tissue and the mesh combine to strengthen the muscle that was weak enough to allow the hernia.
2. Why Covidien Parietex implants are defective
All of the defects with Covidien Parietex hernia mesh implants are caused by the device's use of polyester to form the mesh, rather than the industry standard of using polypropylene plastic. While polypropylene has its own set of serious defects, polyester hernia mesh implants like the Parietex have been found to:
- Be difficult to implant,
- Cause high levels of inflammation,
- Shrink over time,
- Tear away from tissue, unravel, and migrate, and
- Perforate tissues and organs.
2.1 Some Covidien Parietex devices are difficult to implant
The polyester that forms the threads of the mesh used in Covidien's Parietex hernia implants is such a soft and flexible fabric that it folds and wrinkles very easily. During a hernia procedure, this flexibility makes it very difficult for surgeons to correctly manipulate it onto the site of the hernia, where it is supposed to lay flat. As a result, hernias that have been treated with Parietex tend to recur or lead to medical complications.
More recent models of hernia mesh in the Parietex line, like the Covidien Composite and ProGrip models, have a layer of collagen added to the backside of the mesh. This collagen is supposed to add firmness to the underlying polyester, but the results seem to have been mixed and do not help the thousands of people who have had older Parietex devices implanted.
2.2 The polyester in Parietex implants creates high levels of inflammation
Once implanted, the polyester in Covidien Parietex devices causes more inflammation than many other hernia mesh devices.1 The levels of inflammation caused by polyester seem to increase the longer it has been inside the body, as the threads of polyester in the mesh harden and constrict.
The increased inflammation can slow down the healing process and can even lead to chronic infections and pain.
2.3 The polyester in Covidien Parietex devices shrinks after implantation
Even if successfully implanted in a hernia procedure, Covidien Parietex devices shrink over time because polyester contracts and hardens in the conditions normally found inside the body. Shrinking polyester is serious because the mesh is implanted precisely so it can mold into the patient's tissues and muscles and prevent future hernias. When the polyester implant shrinks, it pulls on those very muscles and tissues and causes discomfort and chronic pain. The shrinkage also leads to other, sometimes even more severe, medical complications.
The irony is that Covidien decided to use polyester because it had become clear that the alternative ingredient for hernia mesh, polypropylene plastic, was known to erode, deteriorate, and shrink after being implanted. By trying to avoid polypropylene, Covidien settled on a material that potentially shrinks even more after being implanted.
2.4 Shrinking polyester tears away from tissue and migrates
When a Covidien Parietex device is implanted, surgeons use polypropylene sutures or metal pins to keep the implant in place. However, as the polyester in the Parietex device contracts and shrinks, it strains those moors. Because the polyester is weaker than they are, Parietex implants have been known to tear where the pins and sutures hold them in place. Once torn, the implant folds, clumps together, or moves around inside the body. The torn polyester threads also unravel and migrate, as well.
Because they are far smaller, pieces of polyester can migrate surprisingly far inside the body. Because the polyester causes such high rates of inflammation, wherever the threads lands is likely to become seriously inflamed and cause potentially severe medical complications.
2.5 Unsealed edges on Parietex devices can perforate tissue and organs
Finally, the edges of Covidien Parietex implants are left unsealed, with threads of polyester sticking out on all sides. While this might seem trivial because of how soft and flexible polyester is at the time of being implanted, when polyester shrinks, it also hardens. Once hardened, these exposed threads can become so stiff that they can perforate tissues and organ that come into contact with them.
3. No recall for Covidien Parietex products
Despite these dangers to patients, Covidien has refused to recall any of the models in its Parietex line of hernia mesh products. This has left victims with no choice but to file lawsuits against the company or join existing hernia mesh MDLs for injuries they have suffered from the device.
See Klosterhalfen B, Klinge U, Schumpelick V, Tietze L, “Polymers in hernia repair–common polyester vs. polypropylene surgical meshes,” Journal of Materials Science 35(19):4769-76 (October 2000).