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A number of individuals have experienced painful complications following hernia repair involving Atrium C-Qur mesh, including internal injuries, infections and mesh failure.
STATUS OF ATRIUM C-QUR MESH LAWSUITS: Product liability lawyers are reviewing whether individuals may be entitled to financial compensation through an Atrium C-Qur hernia mesh lawsuit as a result of the manufacturer’s failure to properly research the product or disclose information about the potential risks.
MANUFACTURER: Atrium Medical Corporation
OVERVIEW: The Atrium C-Qur mesh was approved by the FDA in March 2006, through the 510K approval program, meaning it did not have to undergo clinical trials before being put on the market.
Atrium Medical was able to gain approval for the mesh by establishing that it was “substantially equivalent” to other approved mesh, without conducting rigorous testing to ensure that it is safe and effective for hernia repair, chest wall reconstruction, as well as traumatic or surgical wounds.
C-Qur Mesh (“Secure” Mesh) is a polypropylene mesh with an outer coating of a gel made from triglycerides and omega 3 fatty acids. Atrium calls this layer the O3FA layer.
MESH ADHESION AND FAILURE PROBLEMS: Numerous doctors and patients have reported problems with Atrium C-QUR mesh, complaining that it gets stuck to the bowels and other parts of the body, increasing the risk of causing serious injuries, such as organ perforation and gastric ulcers.
Other problems linked to the mesh have included infections and catastrophic failures.
A 2009 study published in the British Journal of Surgery found that the design of the C-QUR and similar meshes prevent adhesion well when first implanted, but that the adhesion prevention measures can degrade over time.
In October 2012, the FDA issued a warning letter to Atrium, noting that the company was failing to adequately address complaints involving the C-QUR mesh and other products. The letter noted that there had been a number of complaints involving C-QUR mesh infections that had not been properly investigated, and that the company appeared to be ignoring numerous sterility complaints, including at least 35 separate complaints of human hair found in medical devices that were supposed to be sterile.
On August 9, 2013, the FDA announced a class 2 C-QUR Edge mesh recall because the coating on the mesh could adhere to the inner packaging sleeve because of high humidity. The recall affected 1,501 units.
ATRIUM C-QUR MESH LAWYERS: For individuals who have suffered permanent injury, Atrium C-Qur Hernia Mesh Lawyers are reviewing potential lawsuits against the manufacturer. Cases are handled on a contingency fee basis, so there are no attorney fees or expenses unless a recovery is obtained.