What is Atrium C-QUR™?

The C-QUR™ Mesh (pronounced “secure”) is a trademarked hernia mesh sold by medical device company Atrium Medical Corporation. The mesh is a medical device that has been used in hernia repair and other surgeries since 2006. The C-QUR is one of a number of hernia mesh products that have led to injuries and complications in individuals who have had the product surgically implanted.

If you have been injured due to the use of the C-QUR Mesh in your hernia repair surgery, you are entitled to seek compensation for your injuries, including financial or economic loss, and for your pain and suffering.

Ken Stern and the attorneys of Stern Law, PLLC, take on faulty surgical mesh cases for injured patients and their families from across the United States. Defective medical device claims are complex cases that often require taking on large corporations. You need an attorney with the resources and determination to pursue these challenging cases. Stern Law has obtained justice and compensation on behalf of many people facing difficult situations similar to you and your loved ones.

Our legal representation is personalized and uniquely tailored to address the needs and concerns of each of our clients. Let Stern Law speak for you.

What does the C-QUR do?

According to Atrium Medical, the C-QUR mesh is intended to be used for hernia repair, chest wall reconstruction, traumatic or surgical wounds, and other surgical intervention procedures that need reinforcement with a non-absorbable supportive material.

The mesh is made from polypropylene and has an Omega-3 gel coating that was designed to prevent the mesh from sticking to abdominal walls. Unfortunately, changes in humidity and sterilization procedures have resulted in the Omega-3 coating not sticking to the mesh as intended, among other problems.

Polypropylene is a polymer plastic that is known to have some issues that can cause problems inside a person’s body, such as shrinkage and erosion of the plastic, and causing a foreign body reaction or infection.

Who makes the C-QUR?

Atrium Medical Corporation develops, manufactures, and distributes the C-QUR hernia mesh worldwide. Atrium is a privately owned medical device company founded in 1981 in Hudson, New Hampshire. It also has locations in Sydney, New South Wales, and SL Mijdrecht, the Netherlands.

Swedish company Getinge Group and its subsidiary, Maquet Cardiovascular, a cardiovascular technologies company, acquired Atrium in 2011 in a $680 million deal.

Atrium manufactures and distributes more than 2.7 million medical products in over 60 countries each year.

How was it approved by the Food and Drug Administration (FDA)?

The C-QUR mesh received FDA 510(k) clearance in 2006, which allowed Atrium to skip thorough pre-market studies after showing that its product was substantially similar to another FDA-approved device.

FDA 510(k) clearance is a way for manufactures to bypass the rigorous and lengthy approval process by indicating that their product is very much like an approved product. The upside for the manufacturer is that its product gets to market a lot faster. The downside is that the manufacturer loses protection from lawsuits alleging negligence, protection that it would have had if it had gone through the normal FDA approval process.

Another disadvantage is that some products are given 510(k) clearance when the FDA-approved products they are substantially similar to have not been on the market long enough for device dangers to be established.

What kinds of injuries has it caused?

The C-QUR hernia mesh has caused complications in patients due to reactions to the Omega-3 fish oil coating, reactions to the polypropylene mesh, problems with sterilization, degradation of the mesh over time, and issues with the mesh becoming stuck in internal organs.

According to Atrium, the Omega-3 gel coating on C-QUR mesh is supposed to prevent it from adhering to the bowel. Some doctors have reported that the coating slips off the mesh upon implantation or within days.

Plaintiffs in the multidistrict litigation case (MDL) allege that Atrium’s mesh adheres to the bowel and other organs, causing:

• Ulcers
• Infections
• Bowel obstructions
• Chronic groin pain
• Nerve damage
• Organ perforation
• Other complications

Some of these injuries can take years to manifest themselves.

How did the C-QUR hernia mesh become popular?

Production and distribution was somewhat limited until Atrium signed a three-year contract with Premier, Inc., a group purchasing organization that supplies more than 1,000 hospitals, in 2010. After Atrium got the contract with Premier, the hernia mesh began to be implanted nationwide at a much higher rate.

Group purchasing organizations (GPOs) allow hospitals to theoretically increase their buying power by buying at a discount with a group of other hospitals or practices. So Atrium would sell the hernia mesh in bulk quantities to Premier, and hospitals that Premier distributes to would agree to only use Atrium’s hernia mesh.

FDA warning, injunction, and product “recall”

In 2012, the FDA sent Atrium Medical a warning letter after an inspection of its facilities. The letter stated 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 and noted that there were 35 confirmed instances of human hair being found in sterilized meshes. It also mentioned that it 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.

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.

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

Although the Hudson facility was shut down, the product is still on the market and some doctors and hospitals are still implanting it.

Other similar products from Atrium

Despite issues with its hernia meshes, Atrium continues to design and produce a variety of hernia mesh products similar to the C-QUR mesh.

They include:

• Atrium C-QUR Mesh
• Atrium C-QUR Mosaic
• Atrium C-QUR TacShield
• Atrium C-QUR V-Patch
• Atrium C-QUR Centrifx
• Atrium C-QUR FX Mesh (formerly C-QUR Lite)

What is being done about the C-QUR hernia mesh?

A number of lawsuits have been filed against Atrium Medical, Maquet, and the Getinge Group nationwide, for injuries including hernia recurrence, adhesions, infections, allergic reactions to the fish oil coating, and other abdominal injuries and complications.

Occasionally when a company is being named in a number of complex lawsuits for the same product or complaint, a federal multidistrict litigation (MDL) will be established to consolidate the lawsuits and allow common questions of fact and discovery to proceed together before the same judge. This process can help litigation reach a resolution more quickly and eliminate duplicate efforts.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) established an MDL for the C-QUR hernia mesh in December 2016, grouping together nearly two dozen individual lawsuits. As of April 17, 2017, there are 27 cases that are part of the MDL. The cases will be heard by U.S. District Judge Landya McCafferty in the District of New Hampshire.

Some of the allegations include:

• Designing and distributing a defective and dangerous medical device
• Failure to conduct adequate research on the mesh
• Failure to investigate reports of product complications
• Failure to warn about the risk of injury
• Failure to recall mesh after problems were reported

Let Stern Law protect 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 the C-QUR Mesh caused you harm.

You may seek compensation for the harm you have suffered by filing a product liability claim against the manufacturers of the C-QUR mesh. You may be entitled to seek 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.

We have the experience and resources needed to pursue justice and to maximize your chances of receiving full compensation for the harm you have suffered. Let Stern Law stand up for you.