Hernia Repair Lawsuit Filed Over Problems with Atrium C-QUR Mesh

After experiencing severe complications from a hernia repair surgery, a Georgia woman has filed a product liability lawsuit against the manufacturer of Atrium C-QUR mesh, alleging it is defective and unreasonably dangerous.

The complaint (PDF) was filed by Julie Ann Bryant in the U.S. District Court for the Middle District of Georgia on September 2, indicating that if she or her physician had been properly warned about the risks associated with Atrium C-QUR hernia repair mesh, as well as the frequency and severity of problems associated with the device, she never would have allowed it to be implanted in her body.

Bryant underwent an abdominal hernia repair in May 2014, at which time Atrium C-QUR mesh was implanted. Over the months after the surgery, Bryant indicates that she suffered severe injury and complications, which resulted in the need for the hernia repair mesh to be removed in September 2014, less than five months later. At that time, Bryant’s physician discovered a sclerotic area of tissue, with underlying tissue inflammation, but no evidence of infection.

According to the lawsuit, problems with Atrium C-QUR mesh caused Bryant to develop a seroma, which involves a collection of fluid that builds up under the skin. The fluid then drained into her abdomen.

The complications led to the need for another hernia repair surgery in March 2015, which left her with the need to miss a substantial amount of work and undergo extensive treatment due to pain from scar tissue buildup and nerve damage to the abdomen.

The complaint was filed against Atrium Medical Corporation, Maquet Cardiovascular, LLC, and Getinge AB, which were responsible for the development and sale of the C-QUR hernia repair mesh.

“Defendants’ C-QUR Mesh was defectively designed and/or manufactured, and was not reasonably safe for its intended use in hernia repair, and the risks of the design outweighed any potential benefits associated with the design,” the lawsuit stated. “As a result of the defective design and/or manufacture of the C-QUR Mesh, there was an unreasonable risk of severe adverse reactions to the mesh or mesh components including: foreign body response; rejection; inadequate or failure of incorporation/ingrowth: scarification; improper wound healing; excessive and chronic inflammation; allergic reaction; adhesions; granulomatous response; seroma formation; nerve damage; tissue damage and/or death, and other complications.”

Bryant presents claims against the manufacturers for defective design, defective manufacture, failure to warn and negligence, seeking both compensatory and punitive damages. In addition, her husband joined the complaint with a loss of consortium claim.

The Atrium C-QUR mesh, which is pronounced “Secure” mesh, was approved by the FDA on March 31, 2006. It is sold for use in hernia repair, chest wall reconstruction and to repair traumatic or surgical wounds.

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.

A number of similar Atrium C-QUR mesh lawsuits are being pursued by individuals throughout the United States, each involving similar allegations that triglycerides in the hernia mesh 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.