Atrium Medical Corporation is facing at least two dozen lawsuits as of January 2017 filed by patients who suffered infections or other complications after undergoing treatment with C-Qur Mesh. Patients who have suffered pain, infection, or other side effects from C-Qur hernia mesh may be eligible to file a lawsuit and receive compensation for their injuries.
What is C-Qur Hernia Mesh?
C-Qur is a surgical mesh patch made with polypropylene mesh. The patch is coated with an all-natural Omega 3 fatty acid (O3FA) gel coating, which is made from highly purified pharmaceutical grade fish oil. C-Qur Mesh is used for hernia repair, as well chest wall reconstruction, treatment of traumatic or surgical wounds, and other surgical procedures requiring reinforcement.
C-Qur Mesh is available under several different brand names, depending on the type of abdominal procedure that is being performed. These brand names include:
- C-Qur: Atrium’s original O3FA patch used in open and laparoscopic hernia surgery.
- C-Qur CentriFX: See-through mesh patch. Used for lateral and medial hernia repair.
- C-Qur Edge: Recalled by the FDA in August 2013.
- C-Qur Film: Abdominal and pelvic surgery. Used to reduce the incidence and severity of post-surgical adhesions.
- C-Qur FX: Open and laparoscopic hernia surgery.
- C-Qur Mosaic: See-through mesh patch. Used in open and laparoscopic hernia surgery.
- C-Qur Tacshield: Medium to large open ventral hernia repair surgery.
- C-Qur V-Patch: Smaller hernia repair, including umbilical, epigastric and trocar defects.
C-Qur was approved by the FDA in 2006 under the agency’s 510(k) approval process. This program allows for the approval of some medical devices without rigorous pre-market testing in cases where the device is “substantially similar” to other medical devices already on the market. C-Qur was approved because it was similar to other mesh devices that were approved by the FDA in the 1990s. However, C-Qur Mesh was the first surgical mesh device approved by the FDA with an O3FA coating.
Complications With C-Qur Hernia Mesh
Multiple studies have shown that patients who are implanted with C-Qur Mesh experience a higher rate of infection compared with other hernia mesh products. Some experts believe that the O3FA coating on C-Qur hernia mesh products may increase the risk of infection for patients who are treated with these devices.
According to one 2016 study, the O3FA coating on C-Que Mesh products can cause “foreign body reactions” after it is implanted, leading to adhesions and potentially serious infections. Patients who experience infections caused by C-Qur Mesh may be forced to undergo surgery to have the device removed or other treatments to resolve complications caused by the device.
In addition to the increased risk of infection, rejection, and foreign body response, patients who are implanted with C-Qur hernia mesh products may also experience other serious complications, including:
- Bowel obstruction caused by dense adhesions connecting C-Qur hernia mesh products to the bowels
- Dental problems caused by chronic infections from C-Qur Mesh, including lost teeth
- Liver problems resulting in an abnormal liver function test
- Organ perforation (holes in the intestines or other organs)
- Neurological problems, including poor memory or concentration
- Rashes covering the abdomen or other parts of the body
- Severe or chronic pain requiring the removal of the device
- Multiple surgeries to remove C-Qur mesh due to complications
FDA Takes Action Against Atrium Over C-Qur
In October 2012, the FDA sent a warning letter to Atrium regarding the high rate of infections experienced by patients treated with C-Qur Mesh. The letter stated that Atrium had failed to address numerous complaints of infection linked to C-Qur hernia mesh products. The FDA also said that Atrium had ignored reports concerning sterility problems associated with C-Qur, including reports of human hairs found in these reportedly “sterile” medical devices.
In August 2013, the FDA issued a class 2 recall for the C-Qur Edge mesh following reports that the O3FA costing on the device could adhere to its packaging when exposed to high humidity. Although Atrium warned physicians to inspect the mesh before implanting it in patients, the company did not recall any of the C-Qur Edge mesh products that had already been distributed.
In February 2015, the FDA filed a lawsuit against Atrium in New Hampshire alleging that the company’s C-Qur hernia mesh products were “adulterated medical devices.” The lawsuit alleged that Atrium’s manufacturing, packaging, storage, and installation of C-Qur products were not in accordance with the FDA’s safety requirements. The agency also issued an injunction to stop Atrium from manufacturing and distributing C-Qur Mesh from its production facility until the company’s practices were in compliance with FDA safety guidelines.
In spite of the FDA’s lawsuit, C-Qur Mesh products continue to be implanted in patients across the country. Because of the continued use of C-Qur by doctors and hospitals, the FDA is still not fully aware of the number of serious infections or other complications caused by these hernia mesh devices.
Lawsuits Filed Against Atrium Over C-Qur Mesh
Atrium is facing at least two dozen lawsuits filed on behalf of patients who suffered complications from C-Qur hernia mesh products. In October 2016, a dozen of these lawsuits were consolidated in a multidistrict litigation (MDL) in the US District Court of New Hampshire, which will oversee lawsuits involving C-Qur surgical mesh that were filed in federal court.
If you or a loved one have experienced infections, pain, or other complications after being implanted with a C-Qur mesh device, you may be eligible to file a lawsuit against Atrium. The first step in taking legal action is to consult with an experienced, professional attorney to advise you regarding your legal rights and walk you through the first steps of filing a case.
The lawyers at Heygood, Orr & Pearson have filed numerous lawsuits against manufacturers of dangerous surgical mesh products or other defective medical devices. Our attorneys have won hundreds of millions of dollars in verdicts and settlements on behalf of our clients, including cases involving dangerous medical devices, defective drugs, and other medical products.
At Heygood, Orr & Pearson, we are committed to bringing the highest standards of ethics and a passion for justice to every client and every case. Our law firm have made it a career priority to hold drug and medical device manufacturers responsible for injuries caused by their products. Our attorneys will work to ensure that you receive the compensation for your injuries that you are entitled to under the law.
For more information about the C-Qur lawsuits filed against Atrium and to learn more about whether you may qualify to file a case, contact the lawyers at Heygood, Orr & Pearson to receive a free legal consultation. You can reach us by calling toll-free at 1-877-446-9001, or by following the link to our free case evaluation form and answering a few brief questions to get started.