Parietex Hernia Mesh & Surgipro Recall
Updated: October 12, 2018
Hernia mesh has been used for many years as the primary solution to patients who suffer from hernias. The mesh usually is placed over the weak area and is super thin, and generally very strong. However, in recent years, there has been an increasing number of complaints from hernia patients who had the Parietex™ hernia mesh implanted during surgery. Reports of side effects have included severe discomfort, chronic pain, and even more serious injuries requiring hospital visits and additional surgeries. Yet, the FDA has issued no formal recall of the Parietex mesh, unlike their Surgipro mesh.
The article below provides detailed information on the Parietex (aka Pariatex and Paratex) mesh product and lawsuits over its side-effects. We cover everything from the manufacturing of the Parietex hernia mesh, potential side effects and medical issues, the potential for a recall, and ongoing lawsuits and settlements. If you're looking for Parietex mesh information, you've come to the right place.
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Helpful article: What to Know About Hernia Mesh Lawsuits Before you File
The History of Parietex Mesh Products
First of all, let's discuss the manufacturing history of Parietex mesh products and the different devices that have been brought to market. The Parietex line has been manufactured by a subsidiary of Medtronic, named Covidien, and was first introduced into the marketplace in 1999. Covidien started out as a textile mill in Massachusetts in 1903 and developed into a health and hygiene company. In 2007, the company was acquired by a larger manufacturer and was named Covidien. The company is incredibly large with operations in over 150 countries and employing approximately 40,000 people. However, this does not mean that the company has been successful. In fact, their history is plagued with recalls. In 2017, the company recalled dozens of other products because of defects and patient complaints. While the FDA has not issued a Parietex mesh recall, cases are beginning to mount.
The manufacturing process, like most problematic mash products, is very important to understand. The majority of surgical hernia mesh products are made from the base material polypropylene. Even though this is the main material used in surgical mesh, that doesn’t mean that it doesn’t come with its share of problems. Everything from inflammation of internal organs to infections to re-herniation has been caused because of polypropylene coming into contact with internal organs. Because of this, Covidien made the decision to utilize polyester in subsequent releases of the product, rather than polypropylene. Once this failed they tried another design that created hook like structures in the polyester fiber. The idea was that this would prevent tearing. This model became known as the Parietex ProGrip like the others, can cause serious internal injuries. This new version made its debut in the early 2000s. However, it turns out that polyester is not much more of a positive material than polypropylene. Polyester still causes massive inflammatory responses in the body and can lead to other injuries.
It also should be noted that there were no human trials at all before Parietex was put out onto the market. This is because the product took advantage of the FDA's 510k approval process (The actual submission can be read here). There were many weaknesses in the original Parietex mesh that were never known until it started being implemented in patient surgeries.
Read more about the FDA 510k approval loophole.
Parietex Mesh Recall and Design History
When the original Parietex hernia mesh was introduced back in 1999, there was no shortage of problems and weaknesses that came with it. As mentioned above, polyester was used as the base material for the original product from Parietex. Polyester had many of the same issues as polypropylene, but also had additional problems and was considered inferior. Using polyester comprises the stiffness allowing the mesh to become more malleable and less rigid than polypropylene. During hernia repair surgery, it became difficult to insert the hernia mesh inside of a patient because of that fact, which led to complications for surgeons and medical professionals. Even though there were plenty of attempts by Covidien to release more stable versions of the hernia mesh, the polyester-based mesh always led to further complications.
Another big problem with these products is related to the outer edge sealing. It’s pretty normal for surgical mesh patches to have sealed edges. However, the Parietex products featured unsealed edges. This encourages the fibers from the polyester material to unravel and stiffen. Whenever the Parietex mesh is implanted within a patient, these outer fibers can harden and become dangerous for the inner organs of that patient. These hard fibers can easily damage the patient’s bowel or anything else that it comes in contact with. Once these fibers unravel from the mesh, they can tear away from the mesh and travel throughout the body. As mentioned above, this polyester will then create inflammatory responses in various parts of the body. Most of which are related to this design flaw.
Another issue that has been recently noted with the Parietex mesh is shrinkage. That's right, it actually can shrink after being implanted in a patient. By using polyester as the base material in the hernia mesh, rather than polypropylene, Covidien unwittingly used a weaker material than what was being used in other meshes (although polypropylene is no better). Because of the shrinking and deformation of the mesh after implantation, there have been plenty of cases of ripping and tearing inside the patient. As you would expect, once this happens, the patient is going to go through re-herniation and repeat operations may be required to fix the issue. To date, the FDA has not issued a parietex mesh recall.
Side Effects & Injuries From Parietex Hernia Mesh
Ever since this mesh was introduced into the market, there have been widespread reports of injuries thanks to contact with it. Now, these injuries have not all been life-threatening. They range from more minor annoyances to those injuries that have led to a life-or-death scenario. While the later is rare, serious internal infections as result of mesh can be life-threatening.
More commonly, we see reports of constant abdominal/groin pain and re-herniation. This is usually the result of mesh that has been torn or punctured because of poor construction. Other common complications occur when the bowels are either strangulated or adhere to the mesh, resulting in bowel obstruction and bowel perforation. Once this happens, it can be seriously difficult to remove the mesh from the tissues that it has adhered to. These are just a few examples of injuries that could occur because of Parietex hernia mesh. For a more detailed injury list, see our page on hernia mesh complications.
Hernia Mesh Lawsuits and Settlements
Now, what has been done and what is being done about these defective medical devices? Beginning in the mid-2000s, hernia patients began complaining
about discomfort and problems arising from the Parietex hernia mesh and other meshes. In fact, between 2005 and 2008, there were approximately over one thousand reports of issues arising from defective hernia meshes. More and more patients came forward to the FDA with issues and some began opening legal cases to find justice and get compensation for their suffering. Currently, there is no FDA issued parietex mesh recall.
In total, there have been over 11,000 lawsuits ever since the problems started arising in patients. These were not only for Parietex products but also for other types of meshes. Millions and millions of dollars have been paid out to victims who have won such cases. Most of these lawsuits have been on the basis of many counts against the mesh companies, like Covidien. Manufacturers are getting hammered on counts of defective construction, and failure to warn patients and doctors of known side-effects.
Additional reading & sources:
Adverse event reports from the FDA
This page is regularly updated with parietex mesh recall information including settlements and FDA rulings.
Published By: The Mesh Attorney
Author, creator, and expert on hernia mesh related injuries, cases, and settlements.
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