A Kentucky woman says her failed C-Qur hernia mesh implantation resulted in hernia recurrence and a need for further surgery.

Plaintiff Jennifer T. says that in December 2015, she underwent hernia repair surgery that used a C-Qur hernia mesh manufactured by defendant Atrium Medical Corp.

Several months later, she says she began experiencing pain and symptoms that her hernia had recurred. She had to have a second surgery to remove the C-Qur mesh in January 2017.

Jennifer now alleges her hernia mesh complications resulted from design flaws in the C-Qur hernia mesh. She says Atrium failed to warn patients like herself of the risks of complications associated with these implants.

Plaintiff Attributes Complications to C-Qur Hernia Mesh Design

Atrium makes the C-Qur implant out of a polypropylene mesh. According to Jennifer, the use of polypropylene in the C-Qur is itself a design flaw.

“Despite claims that this material is inert, a substantial body of scientific evidence demonstrates that this mesh material is biologically incompatible with human tissue and promotes an immune response in a large subset of the population receiving Atrium’s Products,” her complaint reads.

“This immune response promotes degradation of the polypropylene mesh, as well as the surrounding tissue, and can contribute to the formation of severe adverse reactions to the mesh.”

Jennifer also says the suppliers who make this polypropylene mesh warn on its Material Safety Data Sheet that it is not intended for permanent implantation inside the human body.

On top of the problems allegedly associated with polypropylene, Jennifer says the proprietary coating that Atrium puts on the C-Qur increases the likelihood and severity of complications. She says Atrium “adulterated” the polypropylene used in the C-Qur with a coating made from omega-3 fatty acids.

These fish-derived oils may retain proteins and other contaminants that can cause allergic reactions ranging from increased sensitivity, rashes, or even death, Jennifer claims.

Moisture can cause this coating to peel away, Jennifer says, and so does the packaging it’s shipped in. Once this coating begins to peel away, it’s more likely to continue detaching after the mesh is implanted in the patient.

Detachment of the omega-3 coating can lead to rejection and other complications, Jennifer claims.

Jennifer claims Atrium has been receiving reports of C-Qur complications for years. Yet the company has never recalled a single hernia mesh product, she claims. She also accuses Atrium of failing to forward these adverse event reports to the FDA, as required by law.

Instead, she says Atrium aggressively over-promoted the C-Qur mesh as being safe and effective. Jennifer says she and her doctors relied on promotional statements like those when she underwent her original hernia repair surgery.

Jennifer’s C-Qur lawsuit raises claims based on theories of negligence, defective design, defective manufacture, failure to warn and breach of warranty. She seeks an award of economic, non-economic, and punitive damages, court costs and attorneys’ fees as well as any other relief the court sees fit to grant.

This C-Qur Hernia Mesh Lawsuit is Case No. 5:17-cv-00080 in the U.S. District Court for the Eastern District of Kentucky.