Timeline of C-QUR™ Hernia Repair
The C-QUR™ (pronounced “secure”) Mesh has been used in hernia repair and other surgeries since 2006. Manufactured and distributed by Atrium Medical Corporation, the C-QUR is one of numerous hernia mesh products that have caused injuries and complications in people who have had the device implanted surgically.
If the C-QUR Mesh was used in your hernia repair surgery and you believe you were injured as a result, you may be entitled to compensation. Ken Stern and the product liability attorneys of Stern Law, PLLC, represent injured patients and their families in lawsuits against the companies that produce faulty surgical meshes.
Defective medical device claims are extremely complicated. They require a skilled attorney with the right resources and the strategic experience to take on large corporations. Stern Law has secured full and fair compensation on behalf of many clients who have been hurt in these types of cases. Schedule a free consultation with our legal team today.
Tracing events in the C-QUR Mesh timeline
The C-QUR Mesh began production in 2006 and was manufactured and distributed until the FDA issued a permanent injunction in 2015, halting the manufacturing of C-QUR and some related products.
2006
Atrium Medical Corporation, a wholly owned subsidiary of Maquet Getinge Group, receives FDA 510(k) clearance for the C-QUR Mesh, allowing the company to bypass pre-market studies by showing that its device was substantially equivalent to another device already on the market.
2010
Atrium signs a three-year contract with Premier, Inc., a group purchasing organization (GPO). Premier provides medical supplies to more than 1,000 hospitals nationwide, resulting in C-QUR being implanted at a much higher rate.
2012
The FDA sends a warning letter to Atrium after an inspection of its facilities. The FDA found that Atrium’s methods for manufacturing, packing, storing, or installing various devices were in violation of federal standards.
The letter indicated problems with Atrium’s sterilization procedures, including 35 confirmed instances of human hair found in sterilized meshes. It also mentioned that it found four complaints about infections associated with the C-QUR products. However, those complaints were closed without seeking culture tests or noting the devices’ lot number.
2013
The FDA issues a Class II recall of the C-QUR Edge Mesh. The recall affected 1,501 C-QUR hernia meshes but did not result in any of the meshes being pulled from shelves. Atrium sent out a letter to hospitals advising physicians to inspect the C-QUR meshes before implanting to ensure that the Omega-3 coating was still intact. The company told doctors that the fish-oil-derived coating on the mesh could stick to the package liner in high-humidity environments.
2015
The FDA wins a permanent injunction against Atrium, shutting down Atrium’s facility in Hudson, New Hampshire. The injunction also prevents Atrium from producing the C-QUR mesh and a few other products. It may be lifted if the FDA issues a letter declaring that Atrium’s manufacturing, sterilization, and storage procedures have been brought into compliance with federal regulations.
After the injunction, a number of lawsuits were filed against Atrium and its parent companies for injuries caused by the C-QUR Mesh.
October 2016
Lawyers file a motion to create a federal docket for all C-QUR mesh cases filed nationwide. There were 13 C-QUR lawsuits pending in federal courts at the time.
December 2016
The U.S. Judicial Panel on Multidistrict Litigation (JPML) establishes an MDL for C-QUR hernia mesh. This MDL groups together nearly two dozen separate lawsuits.
April 2017
There are 27 cases that are part of the MDL, which will be heard by U.S. District Judge Landya McCafferty in New Hampshire. Some of the allegations include:
- Designing and distributing a defective and dangerous medical device
- Failing to conduct adequate research on the mesh
- Failing to investigate reports of product complications
- Failing to warn about the risk of injury due to the mesh
- Failing to recall the product after problems were reported
Let Stern Law protect your rights after a hernia mesh injury
Do not hesitate to seek legal help if you suspect that a faulty hernia mesh product caused injuries to you or a loved one. At Stern Law, our dedicated product liability attorneys can investigate the circumstances of your surgery and determine whether you have a case.
We can help you pursue full and fair compensation for the harm you have suffered by filing a product liability lawsuit against the manufacturers of the C-QUR mesh. This could include compensation for:
- Medical costs
- Lost wages
- Out-of-pocket expenses
- Emotional trauma
- Pain and suffering
Stern Law has built a strong network of attorneys with extensive experience in medical product liability, medical malpractice, and personal injury cases. Schedule a free and confidential case consultation today to discuss how we can help you and your family.
