Safety Issues and Complications of C-QUR

The C-QUR™ Mesh, a hernia mesh that was manufactured and distributed by Atrium Medical Corporation until a 2015 injunction, has been used in hernia repair and other surgeries since 2006. C-QUR is one of a number of hernia mesh products produced by various companies that have led to injuries and complications in individuals who had the product surgically implanted. Many of the faulty meshes have been recalled or are no longer being produced.

A number of doctors reported problems with the Omega-3 coating on the mesh, which slipped off the mesh before or after implantation in some cases. In instances where the coating remained in place, some patients experienced a reaction to the fish-oil-derived coating. Other patients had a reaction to the polypropylene mesh or had problems with adhesions or the mesh becoming lodged in the bowel.

Our attorneys can help

If you have been injured as a result of the C-QUR Mesh being used in your hernia repair surgery, you may be entitled to compensation for your injuries, including for your medical bills, lost wages, and your pain and suffering.

Ken Stern and the attorneys of Stern Law, PLLC, represent injured patients and their families across the United States in lawsuits and actions against the companies that manufacture and distribute faulty surgical meshes. Defective medical device claims are complex cases that require an attorney with the right resources and determination to take on large corporations. Stern Law has successfully secured compensation for many clients who were facing difficult situations similar to yours.

Our legal representation is personalized and specifically tailored to address the needs and concerns of each of our clients. And we are ready to stand strong for you now. Schedule a free legal consultation today to discuss your options.

Safety issues with C-QUR

During the period in which C-QUR meshes were being manufactured, FDA inspections revealed issues with Atrium’s sterilization processes and a failure to investigate or address complaints about infections resulting from the implanted product.

In 2012, the FDA sent Atrium Medical a warning letter stating that during an inspection of its facilities, the FDA found that the C-QUR hernia mesh and other products produced by Atrium were adulterated because the methods used for manufacturing, packing, storage, or installation of the devices were in violation of federal standards.

The letter pointed out problems with Atrium’s sterilization procedures. It also noted there were 35 confirmed cases of human hair being found in sterilized meshes. In addition, the FDA found four complaints about infections associated with the C-QUR products, but the complaints were closed without getting the results of culture tests or noting the lot number of the devices.

Class II recall

In 2013, Atrium Medical issued a class II recall of its C-QUR Edge Mesh, but the recall did not result in the product being pulled from the market. Atrium sent out letters notifying doctors that the mesh’s coating could stick to the inner lining of the packaging under excessively humid conditions.

Complaints and reports from doctors indicate that the Omega-3 fish oil coating was not only problematic under excessively humid conditions, but under normal conditions as well. Doctors have reported problems with the coating slipping as soon as the device was implanted, or within days of implantation.

FDA injunction

On February 4, 2015, the FDA won an injunction against Atrium, preventing it from producing the C-QUR mesh and other products until its manufacturing, sterilization, and storage procedures are brought into compliance with federal regulations.

Although production was shut down, some doctors and hospitals still have supplies of the C-QUR Mesh and are still using it.

Complications from using C-QUR

Multidistrict litigation (MDL) is currently underway in New Hampshire for plaintiffs suing Atrium and its parent companies, Maquet and Getinge Group, for complications related to the C-QUR Mesh.

MDLs are a way of expediting litigation and avoiding duplicating discovery efforts by handling key aspects of similar cases at the same time. Twenty-seven cases currently make up the C-QUR MDL.

Plaintiffs are alleging a number of complications resulting from using the C-QUR Mesh in their hernia surgery, including:

• Inflammatory responses to the Omega-3 coating
• Immune response to the polypropylene mesh
• Bowel adhesion
• Bowel perforation
• Bowel resection
• Bowel obstruction
• Additional surgeries
• Abdominal rashes
• Severe pain
• Rejection of mesh
• Pseudotumor
• Neuromuscular problems
• Sepsis and septic complications
• Headaches
• Infection
• Loss of coordination
• Vision changes
• Renal failure
• Liver complications

Let Stern Law fight for your rights after a hernia mesh injury

If you suspect that a faulty hernia mesh product is to blame for your injury or for a loved one’s death, Stern Law can help. Our firm can investigate the circumstances of your surgery to determine whether C-QUR Mesh caused the harm.

You may seek compensation by filing a product liability claim against the manufacturers of the C-QUR mesh. Our skilled attorneys may demand compensation for:

• Medical costs
• Lost wages
• Out-of-pocket expenses
• Emotional trauma
• Pain and suffering

Stern Law works with a network of lawyers experienced in medical product liability, medical malpractice, and personal injury cases. We investigate cases and move forward with a focus on addressing our clients’ concerns and advocating for their interests.

A product liability claim involving a hernia mesh injury starts with a free and confidential evaluation of your legal options. If we believe that you have a valid claim, we will obtain your medical records and start investigating.

Our attorneys have the experience and resources needed to pursue justice and demand maximum compensation for the harm you have suffered. Let Stern Law stand up for you today.