With over two dozen pending hernia mesh lawsuits filed against New Hampshire-based medical device manufacturer Atrium Medical, the company allegedly continues to ignore claims it knew its surgical mesh, the C-Qur, caused users great pain, disabilities and, in some cases, forced them to have multiple surgeries.
Lawsuits claim that the mesh, engineered to repair pelvic injuries like hernias, has shown a high rate of failure, resulting in irreversible and severe harm. The C-Qur – designed from polypropylene, a material noted for shrinking – has allegedly shown signs of erosion and leading to infection.
Atrium hernia mesh recall
In 2013, Atrium claimed to attempt a recall of the C-Qur mesh. The problem is that the product was never actually removed from the market. The company only wrote a letter to clinicians warning that the mesh’s coating was capable of sticking to packaging and peeling off the mesh. This was detrimental to the coating’s purpose which was to prevent the polypropylene from making direct contact with a patient’s internal organs.
The FDA started getting numerous reports of the coating peeling off after implantation. In some cases, the coating began to peel off almost immediately. The agency eventually sued Atrium for putting adulterated medical devices into interstate commerce. A permanent injunction against the manufacturers of the C-Qur was also instituted.
A number of studies were implemented to investigate reported complications. A study in Belgium came to an abrupt halt because there was a high rate of C-Qur hernia mesh infections. Another study resulted in similar infections for almost all the implantations. One consistent risk was the mesh sticking to the bowel and actually twisting or perforating the organ, leading to intestinal issues like gastric ulcers, gangrene and sepsis. Other patients with the implant suffered allergic reactions.
While many in the medical community have stopped using the C-Qur hernia mesh, the product is still being recommended by clinicians and implanted in patients.
Why is the C-Qur hernia mesh still on the market?
That question is the basis of the lawsuits that are appearing all over the country. Among the many allegations are the claim that Atrium:
- Failed to adequately research the C-Qur mesh
- Failed to investigate reports of issues
- Discovered problems and failed to recall the C-Qur
- Inadequately warned the public about the mesh’s link to injury in patients
- Created unreasonable danger by designing and selling a defective product
It is important that anyone – you, a family member, or friend – who has had an Atrium C-Qur hernia mesh implanted and eventually suffered any type of infection, gastric ulcer or other complication speak with a defective medical product lawyer quickly. You are likely entitled to compensation for your injuries, but each individual case may have a statute of limitations or deadline. Not only is time of the essence, but so is your health.
C-Qur mesh injury resources
- The Telegraph, Hudson Medical Device Maker Atrium Faces Lawsuits Over Surgical Mesh, http://www.nashuatelegraph.com/news/1046831-469/hudson-medical-device-maker-atrium-faces-lawsuits.html
- Outpatient Surgery, FDA Orders Maquet to Temporarily Suspend Manufacturing at N.H. Facility, http://www.outpatientsurgery.net/outpatient-surgery-news-and-trends/general-surgical-news-and-reports/maquet-s-n-h-facility-shut-down-for-repeat-violations–02-06-15