Atrium Mesh Recalls
Atrium medical corporation produces the C-Qur product line of hernia mesh patches. These products hit the market back in 2006 via the 510(k) approval process, which allows medical device manufacturers to bypass the normal FDA approval process and excuses them from adhering to the otherwise stringent testing and safety guidelines. Because of these loopholes and growing reports of problems, a recall of the Atrium mesh was issued in 2013 and litigation is currently pending against the company.
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The original Atrium C-Qur line featured a revolutionary Omega-3 fatty acid layer designed to integrate naturally with the patient's body over time. Unfortunately, many people began experiencing infections near the operation site and other serious medical issues such as bowel obstruction and reaction to the Omega-3 coating. Once the C-Qur product integrates within the patient's body, it can be complicated and dangerous to remove, particularly if it has already bound to internal organs.
The Atrium C-Qur line includes the following products:
- C-Qur: The first version of the mesh 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 for 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 a minor or small repair.
Atrium C-Qur Mesh Recall
In October of 2013, Atrium got hit with an FDA recall for one of their C-Qur products, the C-Qur Edge. The FDA had discovered that problems with the C-Qur Edge's packaging was causing damage to the mesh and particularly to the Omega-3 coating. At the time, Atrium estimated that around 2,000 devices were defective and it sent notices to surgeons and hospitals nationwide. It is believed that many other hernia mesh products were also defective and went undetected by the FDA and others. These hernia mesh products were implanted in unsuspecting patients over the period of many years.
Atrium Hernia Mesh Lawsuits
A group of attorneys in New Hampshire have filed federal cases against Atrium for its defective mesh products. The cases were consolidated and coordinated in a federal court in New Hampshire. Judge Landya Boyer McCafferty is presiding over the consolidated lawsuits. The case name and number is: Atrium Medical Corp. C-Qur Mesh Products Liabilty Litigation, Case No.: 16-md-2753 LM.
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 is a broad category and include complications from the standalone mesh product. These injuries are also caused by the mesh products of many other manufacturers and are related to a fundamental concern with these types of mesh. That is, the human body is not designed to integrate well with synthetic products. The use of synthetic products (such as mesh) to repair internal body tissues is not ideal application. The body sees the mesh as a foreign body and attacks it.
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 prevent adhesions (a common complication in some other mesh products). But problems with this coating inside the packaging led to the first atrium mesh recall.
Recently we've seen an alarming number of patients that require removal because of serious immune responses caused by the coating. Most commonly infections and severe pain at the surgical site are reported.
Articles & References
Published by: The Mesh Attorney
Author, creator, and expert on hernia mesh-related injuries, cases, and settlements.
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