C-QUR hernia mesh is a surgical device used to repair hernias. A hernia is a protrusion of tissue or organs through the abdominal wall that is unable to push back into the abdomen on their own.
C-QUR mesh is made of polypropylene plastic and is coated in Omega 3 fatty acid. The mesh is intended to be used during the repair of inguinal hernias by way of an intraperitoneal onlay mesh technique where the mesh is placed in the abdomen over a thin layer of tissue that covers the abdominal organs. The mesh then serves as an overlap of the hernia's weak spots. While the mesh does have direct contact with a patient's internal organs, the aforementioned Omega 3 coating stops the mesh from creating scar tissue and swelling around vital organs.
The Food and Drug Administration first approved C-QUR mesh in 2006 through the 510(k) process. The 510(k) process allows approval without testing as long as the design and functionality of the product are based upon a device that the FDA approved in the past. The reasoning for the fast-track is to provide sorely needed drugs and devices to consumers as quickly as possible.
Atrium is the main manufacturer of C-QUR mesh, producing at least eight brands of the mesh, including:
- C-Qur Edge
- C-Qur V-Patch
- C-Qur Tacshield
- C-Qur FX
- C-Qur CentriFX
- C-Qur Mosaic
- C-Qur Film
However, despite Atrium's success, patients have complained of severe side effects that have originated from the Omega 3 fatty acid coating. Allegedly the coating leads to an inflammatory response that leads to bowel adhesion, blocks proper abdominal wall fixation and causes blockage of the small or large intestine. Patients have filed lawsuits against Atrium, claiming that the C-QUR mesh is unreasonably dangerous and contains a defective design.
In late 2016, the U.S. Judicial Panel on Multidistrict Litigation consolidated all Atrium C-Qur hernia mesh lawsuits pending in the federal court system to the District of New Hampshire. In early 2017, plaintiffs in Florida, Illinois, Georgia, Colorado, South Carolina, Kentucky, Massachusetts, Oklahoma and New Jersey petitioned the court to consolidate the lawsuits in Florida.
As cases progress, it will be interesting to see if the Food and Drug Administration recall any of Atrium's mesh products.
Medical malpractice can have devastating effects that last a lifetime. If you have been injured by a physician's neglect, attorneys Charles Gilman and Briggs Bedigian will work to get you the full compensation to which you are entitled. Call 800-529-6162 today or contact them online for a free case evaluation. They handle cases in Maryland, Pennsylvania, and Washington, D.C.