Hernia mesh recipients in recent years have reported severe and debilitating problems following implantation with Atrium C-Qur mesh products. The most common complications include chronic pain, infection, device rejection and hernia recurrence.
Atrium was warned years ago about such results, but elected not to recall their mesh device and failed to warn consumers of the risks. Only after allegations and lawsuits began surfacing did Atrium Medical remove some of their C-Qur mesh products from the market.
Lawyers claim Atrium knew or should have known about the potential risks of their mesh products. Rather than prevent further injuries to patients, Atrium went forward and sold questionable devices. Many medical professionals stopped using the C-Qur hernia mesh due to high infection rates, bowel obstructions, and systemic allergic reactions.
Joe Lyon is a highly-rated Cincinnati, Ohio product liability lawyer representing plaintiffs nationwide in a wide variety of defective medical device and civil litigation claims.
Atrium C-Qur Edge Hernia Mesh Recall
In October, 2012, the FDA issued a warning to Atrium Medical, urging the company to address serious complaints related to infections caused by the C-Qur mesh product. Atrium Medical did not properly manage the issues and the FDA responded in 2013 by announcing a recall of the C-Qur Edge mesh.
The recall stated that the Omega 3 oil coating on the mesh could adhere to the packaging due to humidity exposure. Attorneys believe the same C-Qur coating in question has peeled off in patients’ bodies once implanted, and resulted in severe injuries requiring further operations.
The Omega 3 oil coating was originally designed to assist in the patient’s healing process and reduce the chance of the mesh attaching to internal tissues. Results, however, show the gel coatings simply led to further injuries.
Hernia Mesh Injuries and Complications
The FDA has received serious post-op reports regarding the ProLoop and C Qur mesh devices. The Atrium mesh failure rates are unacceptably high, and allegedly leave patients with permanent and debilitating medical conditions. The mesh, made from polypropylene, is known to shrink, cause foreign body reactions, become infected and erode. Patients implanted with a C-Qur mesh device may suffer from the following:
Infection—the Omega 3 fatty acid gel of C-Qur was designed to create a cleaner mesh implant, less likely to attach to organ tissue, but in many cases patients have suffered from serious infections. There is clear indication that the mesh is unsuitable to be used inside the body. If the hernia mesh adheres to the bowel, it can cause gastric ulcers and infections like sepsis and gangrene.
Chronic Pain—discomfort is the most common side effect after a hernia mesh operation. This is understandable, considering the invasiveness of the surgery, but some patients have suffered severe allergic reactions and other patients have experienced pain so severe they are unable to go to work or perform daily chores. Persistent groin pain affects quality of life in every way.
Rejection—mesh rejection is most commonly caused by an allergic reaction. The body in many patients is unable to accept the makeup of the mesh material, namely the Omega 3 oil.
Organ Perforation—this may be caused by the mesh migrating in the body. Organ perforation is extremely serious and can cause long-term health issues.
Bowel Obstruction—if a mesh device has perforated an organ, it can cause an obstruction of the bowel. This will in turn require an additional surgery.
Patients may also suffer from other side effects including:
• Adverse foreign body response—inflammation and rashes
• Additional Surgeries
• Abnormal Liver Function
• Nerve damage
• Neurological changes
C Qur Mesh Devices
Doctors have reported to the FDA certain cases where the oil coating on the mesh peels off during implantation or very soon after implantation. Despite such issues with the C-Qur mesh, Atrium continued to release products made of polypropylene mesh with an outer coating of Omega 3 fatty acid gel.
Atrium has authorized and sold the following types of mesh for use in hernia abdominal procedures:
• C-Qur Edge (officially recalled)
• C-Qur V-Patch
• C-Qur Tacshield
• C-Qur FX
• C-Qur Mosaic
• C-Qur Film
• C-Qur Centrifix
• C-Qur Lite
Atrium’s C Qur Mesh Lawsuits
Atrium currently faces thousands of pending lawsuits. Medical device companies like Atrium have previously paid millions to settle lawsuits when they market and sell failing medical devices, and plaintiffs expect that trend to continue.
Atrium’s hernia mesh was not proven safe through testing and as a result an increasing number of claims against Atrium have been filed by injured patients and attorneys. Pending lawsuits allege that Atrium should have known about the risks of dangerous ProLoop and C Qur complications, and properly warned patients.