Plaintiff Margaret C. has filed a products liability lawsuit against Atrium Medical Corporation, the manufacturers of the C-QUR hernia mesh implant. She alleges that the manufacturers inaccurately represented the safety and effectiveness of C-QUR.

Margaret’s claim is part of a large multidistrict litigation, or MDL, comprised of many individual claims against Atrium over the C-QUR mesh. Plaintiff allege they suffered complications like C-QUR infection and dangerous autoimmune reactions, all of which they allege could have been avoided with better warnings from Atrium.

Margaret states that due to the defective medical device, she suffered “significant pain and suffering, emotional distress, lost wages and earning capacity, and diminished quality of life.”

C-QUR mesh is a medical device that is surgically implanted to repair abdominal hernias, the bulging of an area of the intestine in a weakened area of the abdominal wall.

C-QUR mesh contains a material known as polypropylene. According to the master complaint for the Atrium MDL, “despite claims that this material is inert, a substantial body of scientific evidence shows that this mesh material is biologically incompatible with human tissue and promotes an immune response in a large subset of the population receiving defendants’ products.”

According to the complaint, an immune response may occur with the degradation of the polypropylene mesh due to the body’s incompatibility with the material. The body begins to degrade the polypropylene mesh along with the surrounding tissue.

The polypropylene in C-QUR is covered with an Omega 3 Fatty Acid Fish Oil, or O3FA. Plaintiffs claim that the manufacturers failed to provide adequate testing to ensure the Omega 3 Fatty Acid Fish Oil is safe to become implanted in the body.

The lawsuit asserts that the U.S. Food and Drug Administration claimed that they “and other governmental regulatory agencies worldwide expressed their stark concerns to defendants regarding severe, life-threatening allergic reactions to the O3FA coating when implanted in humans.”

High humidity levels can allegedly cause the O3FA coating to peel off the polypropylene or stick to the device’s packaging. Plaintiffs allege Atrium “failed to warn or instruct distributors and facilities of critical environmental guidelines, such as relative humidity or temperature during transportation and/or storage of the C-QUR Mesh.”

Atrium allegedly uses ethylene oxide to disinfect the C-QUR mesh. But dry spores are allegedly resistant to ethylene oxide, according to the master complaint. Dry spores that survive the disinfection process could later cause a C-QUR infection after implantation.

What’s more, because these spores can remain dormant for a long time, a C-QUR infection may not set in until months or years after implantation, according to the complaint.

The C-QUR Mesh Lawsuit is Case No. 1:17-cv-00249, in the U.S. District Court for the District of New Hampshire.