Hernia mesh products are used in hernia repair surgeries to provide much needed support to the weakened tissues at the site of the hernia. However, many of these products are made of materials that result in allergic or inflammatory reactions in the patient’s body.
Atrium C-Qur was designed with the prevention of these complications in mind. The manufacturers marketed the hernia mesh product as a device designed to prevent side effects as a result of being coated with fish oil. However, the very fish oil that was meant to prevent complications is at the center of various lawsuits that have been filed against the manufacturer of this hernia mesh product. The lawsuits are being filed by patients who have developed inflammation, severe pain, adhesions and complications requiring corrective surgery.
These lawsuits claim that the fish oil used to coat the hernia mesh is biologically incompatible. The products that have been coated in fish oil (Omega-3 fatty acid) include:
- C-Qur Lite
- C-Qur Mosaic
- C-Qur Edge
- C-Qur Mesh
- C-Qur FX Mesh
- C-Qur TacShield
- C-Qur Centrifix
The mesh products were approved by the Food and Drug Administration (FDA) for use in surgical hernia repair in 2005. However, this approval was done without the products undergoing the usual clinical trials. The product was considered equivalent to other mesh products already in the market.
There are various complications reported by patients. These include the following:
- Organ perforation
- Chronic pain
- Encapsulation of the mesh with scar tissue
- Rash on the abdomen
- Dental problems
Recall of C-Qur Mesh
Atrium, the manufacturer of C-Qur mesh, recalled more than 100,000 units of the C-Qur mesh products including TacShield, Edge Mesh and V-Patch Mesh. The recall was issued because the fish oil coating in the products was shown to peel off the products and stick to the inside of the package.
While Atrium issued a warning and recalled this batch of products, they did not pull the products from the market. The company is now facing lawsuits filed by patients who claim that the peeling of the oil coating while the mesh was in their bodies was responsible for injuries they suffered.
The FDA issued warnings against the use of the mesh in 2012. The warnings were in relation to reports of high levels of infection as well as product contamination. The company was forced to stop manufacturing the mesh in 2015.
If you or a loved one has been injured by C-Qur mesh or any other hernia mesh product, please contact the defective medical device attorneys at Smith Stag. We represent injured victims nationwide.