Atrium Medical Corporation’s C-Qur surgical mesh is used by surgeons to repair hernias. Hernias are weak spots or tears in the abdominal muscle wall that can allow organs or tissue to push through. The C-Qur mesh is made from polypropylene then coated in omega 3 fatty acids (O3FA) which come from fish oil. The fish oil coating was intended to prevent inflammation and scarring from organ tissue adhering to the mesh.
C-Qur Surgical Mesh was FDA 501(k) cleared in March of 2006. Since 2006 there have been multiple subsequent C-QUR brand products.
- April 2008:
- C-Qur Lite Mesh V-Patch (for pre-peritoneal repair)
- C-Qur Edge Mesh V-Patch (for intra-abdominal placement)
- June 2009: C-Qur V-Patch Mesh (small hernia defects)
- January 2010: C-Qur OVT Mesh (“open ventral tab” targeted for open ventral/incisional hernia repair)
- April 2012: C-Qur RPM Mesh (reduced coating, mesh for open and laparoscopic repair; after approval, name changed to Mosaic)
- October 2015:
- C-Qur Mosaic (open and laparoscopic repair)
- C-Qur TacShield (for fixation guidance with large ventral hernias)
Since the launch of the C-Qur line there have been numerous adverse events filled with the FDA.
These adverse event reports list complications including;
- Chronic infection
- Severe abdominal pain
- Serom (fluid buildup at the site)
- Lack of incorporation into surrounding tissue
- Constant burning
- Mesh migration
- Mesh shrinkage
- Skin rash
- Bowel obstruction
Often times, these adverse events result in mesh failure, removal of the mesh and additional surgeries.
In 2013 the FDA announced a Class 2 device recall for the C-QUR Edge Mesh of all sizes and shapes. On July 19th, 2013 Atrium Medical Corporation sent a letter to the accounts and field representatives identifying the problem, product and risk factors. Excessive humidity, over an extended period of time may increase the humidity in the package and potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve.
A number of lawsuits have been filed against Atrium Medical Corporation in regards to their C-QUR mesh. On January 9th, 2017, a lawsuit was filed in New Hampshire claiming that C-QUR’s Omega-3 fatty acid coating (O3FA), also known as fish oil, was the cause of major complications. The plaintiff, who underwent hernia repair surgery in 2013 in which C-QUR hernia mesh was used, reported pain several months after the surgery. He would later find out that the complications caused by the mesh would require him to undergo another surgery. At the time of removal, the surgeon reported “foreign body giant cell reaction,” as well as chronic pain, scar-tissue embedded in the mesh and other complications.
In December of 2016 the Atrium Medical Corp. C-QUR Mesh Products Liability Litigation, a Multi-District Litigation (MDL) was consolidated in the United States District Court, District of New Hampshire under the Honorable Judge Landya B. McCafferty.
C-Qur hernia mesh lawsuits have been filed in federal court. If you or someone you know has had hernia repair surgery, with C-QUR mesh and are suffering from complications, don’t wait call 1800LAW1010 today.
We are conveniently located in several locations in the states of New York and Vermont to ensure you have legal representation close to you. We have offices in: Albany, NY, Saratoga, NY, Schenectady, NY, Plattsburgh, NY, Utica, NY, Buffalo, NY, New York City, NY, White Plains, NY, Rochester, NY – as well as Manchester, VT and Burlington, VT.
Call us today for a free consultation and learn your rights. Call 1800LAW1010 (1-800-529-1010) and take the first steps toward getting the justice you deserve.