Hernia Patch Lawsuit Filed Over Atrium C-Qur TacShield Mesh

According to allegations raised in a recent product liability lawsuit, complications with Atrium C-Qur hernia patch caused a Missouri man to suffer severe and permanent injuries. 

The complaint (PDF) was filed by Richard Heinz in the U.S. District Court for the Eastern District of Missouri on October 8, indicating that the Atrium C-Qur TacShield mesh implanted for repair of an incisional hernia was unreasonably dangerous and defective.

Heinz underwent hernia surgery in April 2012, during which a 15 by 7.5 centimeter Atrium C-Qur patch was implanted. However, the hernia returned in June 2014, along with abdominal pain, and it was confirmed that the problems were caused by mesh contracture, graft mitigation, and that parts of the Atrium C-Qur mesh were adhering to his small bowel. A doctor told Heinz that the mesh had integrated into the viscera so fully that it was inoperable and could not be removed.

The hernia patch lawsuit alleges that the manufacturer knew, or should have known, that the Atrium C-Qur was defectively designed, but failed to inform the FDA, the medical community or patients. As a result of the problems, Heinz reports that he has been left with severe abdominal pain, digestive problems and infections, as well as an abdominal mass that continues to grow. The best his doctor could do was provide him with a list of symptoms that could be used as a warning to indicate when he needs to call 9-1-1 or go to the nearest emergency room.

“Defendants failed to perform or rely on proper and adequate testing and research in order to determine and evaluate the risks and benefits of the Defendants’ C-Qur Mesh,” the lawsuit states. “Defendants failed to design and establish a safe, effective procedure for removal of the Defendants’ C-Qur Mesh, therefore, in the event of a failure, injury, or complications it is impossible to easily and safely remove the Defendants’ C-Qur Mesh.”

The case joins a growing number of similar Atrium C-QUR mesh lawsuits filed in courts nationwide, each involving similar allegations. Pronounced “Secure” mesh, Atrium C-Qur was approved by the FDA on March 2006, for use in hernia repair, chest wall reconstruction and to repair traumatic or surgical wounds. However, it has been linked to a number of problems.

In October 2012, the FDA issued a warning letter to Atrium, citing the company for failing to respond to complaints about the C-QUR mesh and other products. The FDA accused the company of failing to review or investigate any complaints involving C-QUR failures or infections.

Heinz and other plaintiffs claim that triglycerides in the hernia patch can result in immune reactions that cause adverse events and injuries. The complaints also claim that the mesh can cause strong friction between it and the underlying tissue, resulting in injury, and that the mesh degrades over time, leading to internal tissue degradation and other injuries as well.