Covidien hernia mesh products have been around for almost two decades, but that doesn’t mean they are without controversy. More and more complaints are being filed with the FDA regarding concerns over serious mesh defects and injuries emanating from those defects.
- 1. Why are hernia repair patients filing lawsuits against Covidien?
- 1.1 What are some reasons people may be filing lawsuits against Covidien’s Parietex?
- 1.2 What are some reasons people may be filing lawsuits against Covidien’s Parietex Composite?
- 1.3 What are some reasons people may be filing lawsuits against Covidien’s Parietex ProGrip?
- 1.4 What are some reasons people may be filing lawsuits against Covidien’s Parietex Plug and Patch Program?
- 2. What is the status of current lawsuits against Covidien?
- 3. How do I know if I qualify to file a lawsuit against Covidien for the defective hernia mesh product used in my hernia repair surgery?
Covidien is a subsidiary of Medtronic. In 1999, its first hernia mesh product was placed in the U.S. market. The center of its pride — and the center of its most likely litigious products — is the Parietex mesh line. Though there have been no trials or settlements to date, patients are starting to file their lawsuits against Covidien. There are four main implants subject to potential litigation:
- Parietex Composite
- Parietex ProGrip
- Parietex Plug & Patch System.
Consumers are filing their lawsuits for adverse reactions and injuries emanating from the use of these products. Some of the most common complications reported to the FDA include:
Other complications and injuries may result as well — the same type of injuries that can result from any defective hernia mesh product.
The main reason for allegations and lawsuits against the Parietex mesh is its material and design.
- The Parietex is made of polyester and a layer of collagen film. The film disintegrates over time, and when it disintegrates, tissue and organs are no longer protected from the polyester material. Polyester is known to cause severe inflammation. In fact, a study from two decades ago confirmed that “polyester mesh should no longer be used for incisional hernia repair.” And yet, continues to be used by Covidien. 1
- The design includes rough edges and large pores. The edges are intentional so that the mesh would remain in place. Unfortunately, the rough edges can perforate nearby tissue and organs and cause infections and dense bowel adhesions. The large pores in the mesh have been complicit with breaks and tears, causing mesh failure.
The Composite mesh is touted as a mesh meant for long-term stability and enforcement of soft tissues. But it is also problematic due to its material and design.
The Composite is also made of polyester textile coated with an absorbable hydrophilic film on both sides. First, polyester is not as sturdy or durable as polypropylene. 2 Second, the film is composed of collagen of porcine origin and glycerol is a thin layer that disintegrates quickly after implantation of the device. Third, because the “protective” layer disappears so quickly, it does very little to protect the patient’s internal tissue and organs from contact with the polyester mesh. And above-mentioned, polyester has been deemed harmful to the human body and should not be used for implantation purposes.
In addition to these problems, the Composite mesh has had numerous adverse reports filed against it to the Food and Drug Administration (FDA). These reports cite two overall themes:
- The Composite Collagen film is ineffective.
- The mesh is prone to unraveling and tearing. 3
Due to these general issues, serious complications develop.
The Parietex ProGrip mesh is a unique design meant to hold the mesh in place. But it is in the design where the problems lurk. Apart from being made with polyester as well and the issues associated with that, this mesh is designed with thousands of microgrips in lieu of sutures or tacks — hence its name.
The problem: the microgrips act like velcro, and once implanted, the mesh cannot be moved. Its inflexibility leads to tears and fraying. The mesh itself can also unravel. This tendency often requires multiple surgeries and causes:
- Severe pain
- Organ perforation, and
- Pulling or a tugging sensation.
These issues have resulted in many complaints and adverse reports filed with the FDA. 4
1.4 What are some reasons people may be filing lawsuits against Covidien’s Parietex Plug and Patch Program?
The Parietex Plug and Patch system is just what it says: a plug that acts like a cork and an onlay that is the patch. Its specific purpose is the treatment of inguinal hernias, and it is to be used via open surgery rather than laparoscopic surgery. That said, the International Guidelines for Groin Hernia Management specifically suggests “not to use plug repair techniques” for this type of hernia. 5 This system increases the chances of mesh migration and the secondary complications that follow it.
To date, there have been no trial juries set or settlements made by Covidien for any of its hernia mesh products, including those listed above. Cases are, however, being investigated and filed on a regular basis. Complaints and adverse reports continue to be reported to the FDA.
3. How do I know if I qualify to file a lawsuit against Covidien for the defective hernia mesh product used in my hernia repair surgery?
You never know for sure if you qualify to file a claim or lawsuit unless you speak to an attorney experienced in these matters. Generally speaking, however, if you can answer “yes” to the following questions:
- Did you have hernia repair surgery?
- Was a defective Covidien hernia mesh product used?
- Did the defect cause an injury?
- Was/Is that injury monetarily quantifiable?
If the above apply, then you may be eligible to file a lawsuit for compensation. It’s hard to say, however, if these answers are in the affirmative or not for your specific situation without further investigation. The best way to determine what your options are is to contact experienced personal injury attorneys who have specific mass tort experience in medical malpractice and/or product liability. But timing is everything — if the statute of limitations runs out, you can’t file a lawsuit.
Our personal injury and product liability attorneys are currently taking hernia mesh cases now. We have offices locally throughout California but accept these types of cases throughout the United States. Call our office today or complete our online form. We will review your case and your options with you.
- Leber, G.E. MD, Garb, J.L., Alexander, A.I., MD, et al. Long-term Complications Associated With Prosthetic Repair of Incisional Hernias. Arch Surg. 1998;133(4):378-382. doi:10.1001/archsurg.133.4.378.
- Klosterhalfen, B., Klinge, U., Schumpelick, V., Tietze, L. Polymers in hernia repair – common polyester vs. polypropylene surgical meshes. Journal of Materials Science (2000) 35: 4769. https://doi.org/10.1023/A:1004812410141.
- FDA. Adverse Reports on Parietex Composite Hernia Mesh.
- FDA. Adverse Reports on Parietex ProGrip.
- Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12. International guidelines for groin hernia management. HerniaSurge Group.