Research conducted by the Food and Drug Administration (FDA) shows that over a million hernia repairs are done each year. Beginning in the 1980s, surgical hernia mesh has been one of the most common methods utilized to address hernia injuries. Other FDA research shows that over 90% of groin hernia repair methods utilized these devices. Tragically, if defective hernia mesh is used, a patient can end up facing life-changing consequences. If you or a loved one has been impacted by defective mesh, you should not hesitate to contact an experienced defective product attorney. It also helps to understand some basic details about the nature of these lawsuits.
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Defective Hernia Mesh Injuries are Surprisingly Common
Surgeries to repair pelvic injuries are not only surprisingly common, but they are also often painful and require a lengthy recovery process. Most surgeries involving hernia mesh rely on the mesh to provide additional support at the hernia site. Unfortunately, defective mesh can leave victims facing serious complications. Defective mesh can also sometimes prove fatal.
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The Role of Hernia Mesh
Hernias occur when internal organs burst through the wall of muscle or tissue surrounding the area. Surgical mesh is utilized to repair hernias by providing additional support to the weakened muscles or tissue. Hernia mesh is classified as either absorbable or non-absorbable. When a non-absorbable mesh is placed in a patient, it is viewed as a permanent implant reinforcing the repaired hernia. Absorbable mesh, however, is viewed as a method of providing temporary support to an area while new tissue grows.
One of the primary differences between mesh and using stitches is that mesh can move or shrink which can damage other organs and lead to other complications.
Examples of Defective Hernia Mesh Products
Certain types of hernia mesh products have become more associated with defects than others. Some of the most common types of hernia mesh products that have come into focus due to their high rate of adverse complications include:
- This heavy-weight mesh was used primarily to treat inguinal hernias. Studies, however, have since shown that the mesh erodes slowly and can end up causing significant pain.
- C-QUR. Produced by Atrium Medical, C-QUR is a hernia mesh that was recalled in 2013 following reports that the product sticks to its inner package lining. Additional research has revealed that C-QUR is associated with an increased infection rate. Due to these dangers, an injunction was issued against Atrium to prevent the company from manufacturing C-QUR.
- Released in 1995, this mesh made by Gore-Tex, unfortunately, grew bacteria in its pockets which were created by degradation. DualMesh also led to other serious complications including bowel obstruction.
- A hernia mesh produced by the Davol company, a recall for the product was first issued in 2005 because Kugel was associated with various side effects including hernia recurrence and pain. Following an updated design, the mess was later recalled in 2006 and 2007 due to reports of bowel perforations.
- Manufactured by Covilden, Parietex is formed from polyester instead of polypropylene. The product has several potentially dangerous qualities. The material is lightweight, which can make it difficult to place appropriately. The material also has jagged edges, which can cut internal organs.
- Proceed Mesh. A lightweight mesh that was introduced in 2003, Proceed Mesh utilizes fabric over polypropylene which means the polypropylene does not come into contact with nearby organs. This fabric is made from oxidized regenerated cellulose which is separate from polypropylene.
- Prolene Hernia System. Introduced in 1997, this system is an implant utilized to treat inguinal hernias. The device contains a plastic mesh created from polypropylene. The system is unfortunately defective due to its use of polypropylene, which is a substance that erodes when exposed to oxygen. Due to this erosion, the tissues, as well as the blood that surround the area, make it likely that the mesh implant will deteriorate over time. During deterioration, polypropylene shrinks and pulls on the abdominal muscles, which in turn causes chronic and intense pain.
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Side Effects Associated With Mesh Injuries
Abdominal wall hernias frequently require surgery, which sometimes involves the use of a mesh product. Many synthetic hernia mesh products were rushed by manufacturers to the market without little analysis of the danger these products presented. Some of the most common design defects associated with hernia mesh include the use of coatings on the product that causes adverse reactions, the hardening of mesh, and rejection of the mesh by the patient’s body. Patients most commonly end up facing side effects like infections, nerve damage, and intestinal obstruction.
How the FDA Responded to the Danger of Mesh
The FDA has not made any recalls of hernia mesh products. The agency, however, has engaged in several actions to protect consumers from being harmed by these products. From 2009 to 2013, the FDA participated in 10 inspections of locations that produced hernia mesh. The FDA determined that significant violations at these facilities made the hernia mesh dangerous. As a result, in 2015, a federal judge issued a decree ordering one of the facilities to cease manufacturing the mesh.
To dissuade consumers from receiving procedures involving surgical mesh, the FDA in 2014 issued a safety message to consumers addressing the potential risks involved with the product. The message addresses the various complications commonly faced by hernia patients including chronic pain, infections, organ damage, and the recurrence of hernias. In the communication, the FDA advised patients to ask a series of questions if their medical provider plans on using hernia mesh during the surgery that addresses whether the procedure is necessary and whether any alternatives to mesh exist.
Obtain the Assistance of a Compassionate Hernia Mesh Attorney
At the Law Offices of Cohen & Jaffe, LLP, we understand the challenges faced by victims of defective hernia mesh and the challenges they can end up facing. From the start of your case to the end, you can trust our legal team to bring the skills necessary to make sure that you obtain the results that you deserve. Contact our law office today to schedule a free case evaluation.