Surgical mesh has been used for many years in patients who suffer from hernias. Hernia mesh is typically placed over the weakened or herniated area(s) to provide structural support and prevent recurrence of the hernia.
Recently, there has been an increasing number of complaints from hernia patients who had a Parietex hernia mesh (aka Pariatex mesh and Paratex mesh) implanted during surgery.
The reports of Parietex hernia mesh complications and side effects include severe discomfort, chronic pain, and even more serious injuries requiring hospital visits and additional surgeries.
Despite increasing complaints, the FDA has not yet required a recall of the Parietex mesh, unlike a prior recall of the Company’s Surgipro surgical mesh.
Below we provide 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.
To get fast answers about a legal claim for compensation due to injuries you’ve suffered from a hernia mesh problem, contact us now for a free, no obligation consultation.
Source article: What to Know About Hernia Mesh Lawsuits Before You File
The History of Parietex Mesh Products
First, let’s discuss the manufacturing history of Parietex mesh products and the different devices that have been brought to the market. The Parietex line is manufactured by Covidien, a subsidiary of Medtronic, and was first introduced into the marketplace in 1999.
The company first 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 renamed Covidien.
The company is incredibly large with operations in over 150 countries and employs approximately 40,000 people.
Covidien’s history is plagued by FDA recalls. In 2017, the company recalled dozens of products because of defects and patient complaints. While the FDA has not issued a Parietex mesh recall, the case for a recall is growing.
The manufacturing process, like most problematic mesh products, is 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.
The implanting of polypropylene in the human body has led to complications as varied as inflammation of internal organs to infections to re-herniation. These complications are caused because this polypropylene comes into contact with internal organs.
Because of these known issues, Covidien made the decision to use polyester in subsequent releases of their mesh product, rather than polypropylene. When this failed they tried yet another design that created hook-like structures in the polyester fiber.
The reason for these modifications was to prevent tearing. This hook model became known as the Parietex ProGrip and like prior designs, it can cause serious internal injuries. This new version made its debut in the early 2000s.
Despite the change in material and design, Covidien quickly found out that polyester is not much better than polypropylene when putting inside the body. Like polypropylene, polyester can still cause a massive inflammatory response in the body, which in turn can lead to other significant injuries.
Like with most surgical mesh products, Covidien did not conduct human trials before putting Parietex mesh into the market. This is because Covidien took advantage of the FDA’s 510k fast-track approval process. The actual submission can be read here). Read more about the FDA 510k approval loophole.
Without human trials, the serious complications and possible side effects from the Parietex mesh went undiscovered until patients started suffering and reporting these problems to the FDA.
Parietex Mesh Complications 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 Parietex product. Polyester had many of the same issues as polypropylene, but also had additional problems and was considered an inferior material for this use.
Using polyester compromises 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 this issue, 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 in a patient, these outer fibers can harden and become dangerous to the patient’s inner organs. 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. The mesh can actually shrink after being implanted in a patient. By using polyester as the base material in the hernia mesh, rather than polypropylene, Covidien 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.
Parietex Mesh Injuries and Side Effects
Ever since this mesh was introduced into the market, there have been widespread reports of injuries from its use. These injuries have not all been life-threatening. They range from mere minor annoyances to injuries that have led to a life-or-death scenario. While the later is rare, serious internal infections as a result of the mesh can be life-threatening.
More commonly, we see reports of chronic 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 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
What has been done and what is being done about these defective medical devices? Beginning in the mid-2000s, hernia patients began complaining about complications and side effects from hernia mesh surgery, including the Parietex hernia mesh and other meshes.
Between 2005 and 2008, there were 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.
Individuals have now filed over 11,000 personal injury lawsuits over surgical meshes and their complications. 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 or settled their cases. Most of these lawsuits were filed against mesh manufacturers like Covidien for failing to warn patients (and doctors) about known complications and side effects of these mesh products. The mesh manufacturers are also being sued for selling defectively designed products.
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Adverse event reports from the FDA