Atrium Mesh Recalls
Atrium medical corporation produces the C-Qur product line of hernia mesh patches. These products ht the market back in 2006 via the 501(k) approval process which allows medical device manufacturers to bypass normal FDA approval process, and excuses them from adhering to the otherwise stringent guidelines. Because of these loopholes, an Atrium mesh recall was issued in 2013 and litigation is currently pending against the company
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The original C-Qur line featured a revolutionary Omega-3 fatty acid layer designed to integrate naturally with the patients body over time. The problem is that many people began experiencing infections near the operation site and other issues such as bowel obstruction and reaction to Omega-3 coating. Unfortunately, once this product integrates with patient, it can be very difficult and dangerous to remove (especially if it has binded to internal organs.
The C-Qur line includes the following products
- C-Qur: The first version of the patch featuring an Omega-3 fatty acid coating
- C-Qur CentriFX: Another version used primarily for medial hernia repair
- C-Qur Edge: The edge received a class 2 recall from the FDA for packaging issues
- C-Qur FX: Used mostly laparoscopic hernia repair.
- C-Qur Tacshield: Mesh for the surgical repair of medium to large size open ventral hernia repairs.
- C-Qur Mosaic: Transparent mesh used for laparoscopic hernia repair.
- C-Qur V-Patch: Mostly used in operations needing minor or small repair
Atrium Mesh Recall
In October of 2013 Atrium finally got hit with an FDA recall for one of their C-Qur products, the C-Qur Edge. It was discovered that issues with the product's packaging led to damaged mesh (particularly with the Omega-3 coating). Atrium estimated that just under 2,000 devices were defective and sent notice's to surgeons and hospitals nationwide. The reality is that many of the defective products went undetected and were implanted in patients over the next several years.
Atrium Mesh Lawsuit
A group of attorneys in New Hampshire have recently filed a federal case against Atrium and is seeking victims nationwide. The plan is to move forward with a muti-district litigation with Judge Landya Boyer McCafferty presiding over the entire litigation. The video below comes from the Hollis firm and explains the details including the s/n of the products in question
C-Qur Mesh Injuries
C-Qur is known injuries such as infections, bowel obstructions, internal bleeding rash, allergic reactions to name a few. There have been multiple scientific articles that support this (please see our list below).
You can broadly separate C-Qur injuries into two categories based on the root cause: Adhesion injuries and Omega- 3 coating Coating injures. Adhesion injuries really is a broad category and includes complications from the standalone mesh product. These are present in many of the other manufacturers and are related to a fundamental concern with these types of products. That is, the human body is not necessarily designed to integrate well with synthetic products. While there are certainly exceptions to this idea, in general the body is intended to be a self-healing machine. The use of synthetic products (such as mesh) to repair the body is just not ideal.
The Omega-3 injuries are associated with the fatty acid coating on the mesh. This coating is intended to be naturally absorbed by the body and thus preventing adhesions (a common complication in some other products). problems with this coating inside the packagaing led to the first atrium mesh recall.
Recently we've seen an alarming number of patients that require removal because of serious immune responses cause by the coating. Most commonly infections and severe pain at the surgical site are reported
Articles & References
Please see our news blog for updated Atrium mesh recall information.
Published By: The Mesh Attorney
Author, creator and expert on hernia mesh related injuries, case and settlements.
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Date of operation
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