Atrium Hernia Mesh
Atrium C-Qur Mesh is a polypropylene mesh that was designed for use in a myriad of surgical procedures, including:
- Hernia repair
- Chest wall reconstruction
- Traumatic or surgical wounds
- Other fascial surgical intervention procedures that necessitate non-absorbable supportive material
The mesh is lined with an outer coating of gel that is manufactured with omega 3 fatty acids.
Unfortunately, as our Boston mesh injury lawyers know, it is also being cited in a host of new lawsuits alleging defective, dangerous design. Plaintiffs in these cases are seeking financial compensation for injuries and illness caused by these alleged defects. Those affected have asserted problems that include:
- Allergic reactions
- Abdominal pain
- Organ perforation
- Bowel adhesions (scar tissue that connects tissue that isn’t supposed to be connected)
- Failure of the mesh
- Erosion/ break-down of the mesh
- Revision surgery
Although no physician will claim any surgery is risk-free, the fact is that the risk posed in these cases is unreasonable. Patients were put at a foreseeable risk of serious injury when this mesh product was rushed to the market without adequate testing and analysis.
Introduction of Atrium C-Qur Hernia Mesh
Atrium C-Qur (pronounced “Secure”) was fast-tracked to the public via a U.S. Food and Drug Administration approval system called a 510(k) Clearance. This is a process whereby the manufacturer of a device can register to notify the FDA of their intent to market a medical device 90 days in advance (a premarket notification). The FDA then determines whether the devices is substantially equivalent to a device that’s already been approved.
In this way, the manufacturer sidesteps the normally rigorous process (i.e., premarket research, extensive studies, etc.) that is required before a medicine or medical device goes on the market. That’s what Atrium did with its C-Qur Hernia Mesh device back in 2005. The company professed its product was substantially similar to another mesh that was created in the 1990s.
It was not long after the product started being routinely used in surgeries that problems arose and product liability lawsuits began to pile up. Even so, the company continued to introduce similar new mesh and surgical products. These have included:
- Atrium C-Qur Centrifix
- Atrium C-Cur V-Patch
- Atrium C-Qur Mosaic
- Atrium C-Cur FX Mesh
- Atrium C-Qur TacShield
These products are all made with that same polypropylene mesh with the outer gel coating.
Atrium Hernia Mesh Problems
Allegations are that Atrium was aware or should have been aware that its hernia mesh products posed a possibility of infection, allergic reaction and other internal injuries and ailments. Although few medical devices boast a 100 percent success rate, the failure rate of Atrium’s Hernia Mesh appears to have been unreasonable.
The FDA issued a warning letter in 2012 to the corporation, indicating the firm was not properly addressing the numerous complaints piling up regarding infections associated with the C-Qur hernia mesh. The company also was allegedly turning a blind eye to complaints about lack of sterility. At that time, there were at least 35 complaints of human hair found in the devices, despite the fact they were marketed as sterile.
Regulators also chastised the company for altering the temperature during the mesh manufacturing process. The company defended itself by explaining some of the mesh pieces had started to burn during the process, but failed to explain exactly why.
Then in August 2013, the FDA issued a class 2 recall of the Atrium C-Qur Edge mesh device due to the fatty acid coating sticking to the inner package lining in high humidity. Approximately 1,500 Atrium hernia mesh devices were affected, but none were actually pulled off the shelf. Rather, physicians were warned to check the coating to make sure it was intact before implanting it during surgery. Questions remain, though: If the coating could so easily adhere in the packaging, is it possible it could peel off once implanted?
In 2015, the U.S. government filed a lawsuit on behalf of the FDA, alleging the company’s ways of manufacturing, packaging, storing and installing the devices failed to conform to acceptable manufacturing practice for medical devices. The FDA then issued a permanent injunction halting the making and distribution of C-Qur hernia mesh, asserting that medical devices have to be safe, effective and of high quality – and this one was not.
What’s more, the warnings this company gave regarding the potential danger fell far short. The company promised this product would be safe and effective, but the research and growing number of lawsuits indicates it is not.
If you suffered complications as a result of surgery that involved implanting Atrium C-Qur hernia mesh, an experienced product liability lawyer can help you determine your legal options.