Hernias are a common, yet painful, condition that many people suffer from at some point in their lives, and surgery is usually the only treatment. A hernia occurs when tissue or organs bulge through a weak spot or tear in the abdominal muscle. To repair a hernia, surgeons must reinforce the damaged muscle wall. The preferred method for doing this today is by using a device called surgical mesh. While there are safe and reliable brands available, it has recently come to light that C-Qur Mesh products produced by Atrium Medical Corporation (which is now a part of the Maquet Getinge Group) may be causing more harm than good to patients, leading to nationwide lawsuits.
How Does Surgical Mesh Work?
To repair a hernia with surgical mesh, the surgeon places the mesh over the hernia defect, then uses sutures, tacks, or surgical glue to hold the mesh in place. This allows the hernia to heal and develop new tissue over the injury site. The mesh may be made of materials that are absorbed by the body over time, or it may be permanent. C-Qur surgical mesh products are made of polypropylene, a type of plastic, and do not dissolve in the body. They are coated with a fish oil product high in Omega-3 fatty acids, which is intended to reduce the amount of inflammation and scar tissue creation. This may not be the case, however, as multiple studies have begun to question whether it actually leads to greater chance of infection or other dangerous side effects.
C-Qur's Troubled History With the FDA
Atrium’s line of C-Qur Mesh first received approval by the Food and Drug Administration in 2006 as part of a fast-track program that allowed the company to skip pre-market studies. However, in 2012, the FDA sent a letter to Atrium, warning the company that it was ignoring numerous complaints about the product. These complaints included dangerous manufacturing issues and sterilization process problems with multiple Atrium products, and even multiple instances of human hair being found inside “sterile” product packaging.
In 2013, over 1,500 Atrium C-Qur Edge Mesh products were recalled, due to the fish oil adhering to the inside of the packaging rather than the mesh. However, the company did not remove the product from shelves; instead, it merely warned physicians to inspect the mesh before implanting it.
In 2015, the FDA finally filed a lawsuit against Atrium to stop production of the C-Qur Mesh and quickly issued a permanent injunction barring the company from manufacturing or distributing C-Qur Mesh products. Since then, many doctors and hospitals have stopped using the products, but they still remain available and are used in surgeries.
Complications Reported Following C-Qur Mesh Surgery
Though surgical mesh has been successfully used to repair hernias for decades with few complications for patients, newer mesh products have seen a greater incidence of side effects and infections after the surgery. Patients with defective mesh products have experienced problems such as:
- Mechanical mesh failure, causing hernia reoccurrence
- Tissue erosion
- Mesh migration
- Organ perforation (puncture)
- Internal bleeding
- Bowel obstructions
- Adhesions, a form of painful scar tissue inside the body
- Increased infection rates
- Immune responses leading to implant rejection
- Severe pain
- Rashes on the abdomen and other parts of the body
Fed-up patients have since started filing lawsuits against Atrium, with at least 24 federal lawsuits pending. In October of 2016, attorneys representing surgical mesh patients filed to consolidate the lawsuits into a federal Multi-District Litigation (MDL) in New Hampshire. The request was approved and a judge was appointed in December. The lawsuits include allegations that that the company caused severe injuries to patients due to negligence, failing to warn about the dangers of their mesh product even though it knew (and hid) the fact that its mesh products were dangerous.
How to Get Legal Help for Your Surgical Mesh Complications
If you’ve been injured by a defective surgical mesh product, you have the right to seek compensation in a court of law. A law firm with experience handling defective medical devices can help you determine if you’re eligible to file a personal injury lawsuit against the manufacturer and can help you financially recover from the costs, including medical bills, rehabilitation, lost wages, pain and suffering, and more.
For more information about Texas surgical mesh lawsuits, contact Wayne Wright LLP for a free, no-obligation consultation to discuss your legal options today.