Atrium C-Qur Mesh Lawyer
The intended use of the C-QUR products was as a tissue separating mesh to be used in hernia repair, chest wall reconstruction, traumatic or surgical wounds, and other connective tissue surgical procedures requiring reinforcement with a non-absorbable supportive material. It was marketed to physicians as a biocompatible fish-oil coated film that reduced inflammation, but as it turned out, the coating on the mesh causes infection, pain, fluid buildup under the skin surface, and internal scarring. Patients have reported a host of adverse events resulting from these devices, including chronic pain, infections, organ perforation, rash, bowel obstruction, and additional surgeries resulting from the damage the device has caused.
Not only is the fish oil ineffective, it is not biocompatible with the body as promised, and causes allergic reaction, pain, severe, dangerous infections, and rejection. The mesh can move and “travel” to other parts of the body, requiring more than just removal, but further repair than was originally required in the first place. To date, more than 733 adverse event reports have been filed, including
- 583 Device-related injuries
- 82 Device malfunctions
- 45 Device-related deaths
- 23 Other
How can an Atrium C-Qur mesh lawyer help?
By contacting one of our professionals today at the Hernia Mesh Lawsuit Lawyers, you can find out if you have a viable case for compensation. There are countless numbers of individuals who experienced infections after C-Qur mesh was used in their surgery. This is because Atrium C-Qur medical failed to inform patient of the possible risks that are associated with this product. As a result of the companys silence, the FDA announced a recall in August of 2013. Some of the severe side effects range from:
- Bowel obstruction
- Infection and sepsis
- Difficult removal resulting in bowel perforation
- Severe pain
- Liver failure
- Kidney failure
- Mental changes
The C-QUR was first cleared for use by the FDA in March of 2006. In April of 2008, the C-QUR Lite Mesh V-Patch (for pre-peritoneal repairs) and the C-QUR Edge Mesh V-Patch (for intra-abdominal placement) were then released. Following that, in June of 2009, the C-QUR V-Patch Mesh was released for the repair of small hernia defects. Next, the C-QUR OVT Mesh was released in January of 2010 for open ventral/incisional hernia repair. Then, in April of 2012, the C-QUR RPM Mesh was released and featured as a reduced coating mesh for open and laparoscopic repair. After its approval, the name was changed to Mosaic. Finally, in October 2015, the C-QUR Mosaic for open and laparoscopic repair and the C-QUR TacShield for fixation guidance with large ventral hernias were released.
In October of 2012, the FDA filed a letter of warning to Atrium Medical Corporation regarding some of its medical devices, and in particular because of the many complaints related to the C-QUR hernia mesh related infections. In July 2013, a Class II Device Recall was issued by the FDA on the Edge Mesh and warned physicians to carefully inspect C-QUR meshes to insure intactness before implanting. Still, Atrium did not pull these from the shelf. In February of 2015, The United States of America, on behalf of the FDA, filed a lawsuit against Atrium Medical Corp, alleging that Atrium introduced inferior quality medical devices into interstate commerce and were not conforming with good manufacturing practice for medical devices. This led to a permanent injunction against Atrium for its practices.
Our lawyers have been winning cases nationwide from New York to the coasts of California. If you or a loved one has suffered as a result of this kind of misleading information and the defective quality of these meshes, or have experienced threatening complications and have required surgical intervention, contact our office today.