Complications Associated with the C-QUR Mesh Device
The U.S. Food and Drug Administration approved the C-QUR (pronounced “secure’) in 2006 through its 510(k) approval program, which allows certain medical devices to enter the market without the typical level of testing and pre-market research. Even though there were signs of problems with the design of the C-QUR, Atrium chose to make the device available to the public.
The C-QUR is made of a polypropylene mesh with an outer coating derived from fish oil. Many patients who have filed lawsuits against Atrium allege the fish oil caused allergic reactions that led to severe health issues. Other complications associated with the C-QUR include:
- Twisting or perforation of the bowels, leading to serious intestinal problems such as gastric ulcers
- Chronic infections
- Additional surgical procedures to revise or remove the mesh
- Bowel obstruction
- Hernia recurrence
Plaintiffs in C-QUR hernia mesh lawsuits allege the manufacturer either knew about the potential for complications or should have known about the risks. They also allege the company chose to prioritize profits over the health of patients by withholding information about the risks from medical professionals as well as the public. Some plaintiffs are also alleging that Atrium halted production on certain C-QUR models due to high rates of complications, and chose not to notify patients or doctors.