Covidien 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 to provide structural support and prevent hernia recurrence.
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 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 hernia mesh lawsuits over its side effects. We cover everything from the manufacturing of the Parietex hernia mesh, potential side effects, 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 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 started 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 has 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.
Like most problematic mesh products, the manufacturing process is important to understand. Most surgical hernia mesh products are made from the base material polypropylene. Even though this is the primary material used in surgical mesh, that doesn’t mean that it doesn’t come with its share of complications.
The implanting of polypropylene in the human body has led to complications such as inflammation of internal organs and infections to re-herniation. These complications are caused because this polypropylene comes into contact with internal organs.
Because of these known issues, Covidien used 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 discovered that polyester is not much better than polypropylene when put inside the body. Like polypropylene, polyester can still cause a massive inflammatory response in the body, leading 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 510(k) fast-track approval process. The actual submission can be found here). Read more about the FDA 510(k) approval loophole.
Without human trials, the severe 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 in 1999, no shortage of problems and weaknesses 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.
Polyester compromises the stiffness, making the mesh more malleable and less rigid than polypropylene. During hernia repair surgery, inserting the hernia mesh inside a patient became difficult, leading 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 standard 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 stiff fibers can easily damage the patient’s bowel or anything else with which it comes in contact.
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 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 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 will undergo re-herniation, and repeat operations may be required to fix the issue. To date, the FDA has not issued a Parietex mesh recall.
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Parietex Mesh Injuries and Side Effects
Since this mesh was introduced into the market, there have been widespread reports of injuries. These injuries have not all been life-threatening. They range from minor annoyances to injuries leading to a life-or-death scenario. While the latter is rare, severe internal infections resulting from the mesh can be life-threatening.
We commonly 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 perforation. Once this happens, removing the mesh from the tissues it has attached to can be difficult. These are just a few injuries that could occur because of Parietex hernia mesh. See our page on hernia mesh complications for a more detailed injury list.
Hernia Mesh Lawsuits and Settlements
What has been done, and what is being done about these defective medical devices? 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 problems, and some began opening legal cases to find justice and get compensation for their suffering.
Individuals have filed over 11,000 personal injury lawsuits over surgical meshes and their complications. These were not only for Parietex products but also other types of meshes.
Millions of dollars have been paid 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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Sources:
Adverse event reports from the FDA
Scientific Articles