C-Qur Composite Mesh
Manufactured by Atrium, C-Qur composite mesh can be used for more than just ventral or inguinal hernias. Surgeons also use this mesh for chest wall reconstructions and to repair traumatic wounds.
But, ventral hernias are the most common. This occurs when internal organs squeeze through a hole or weak spot of a previous surgical incision. Ventral hernias occur weeks, months or years after the initial surgery. Doctors can repair some with a few stitches. However, large and often complex hernias require major reconstructive surgery on the abdominal wall.
During the surgery, surgeons often use a mesh like C-Qur to reinforce the abdominal wall to prevent a hernia from re-opening. Atrium made C-Qur from flexible, non-absorbable polypropylene filaments woven into a fabric and laminated. The mesh uses an Omega 3 fatty acid coating. They claimed that this coating prevents adhesions when first implanted.
Instead, the Omega 3 fatty acid coating causes the body to initiate an immune response. This response causes pain, warmth and a rash to the skin closest to the mesh.
C-Qur FDA Approval
The FDA originally approved Atrium’s C-Qur in March 2006, using the FDA 510(k) approval program. This allowed the mesh to be on the market without rigorous safety studies because it was “similar” to another hernia patch.
Despite signs of potential problems with the Atrium C-Qur mesh design, the manufacturer has introduced a variety of similar products for use in hernia repair, chest wall reconstruction, and treatment of traumatic or surgical wounds, including:
- Atrium C-Qur Mesh
- Atrium C-Qur Mosaic
- Atrium C-Qur TacShield
- Atrium C-Qur V-Patch
- Atrium C-Qur Centrifx
- Atrium C-Qur FX Mesh (formerly C-Qur Lite)
Atrium constructed all of these products out of polypropylene mesh, with an outer coating of gel made from omega 3 fatty acids.
C-Qur Infection Reports
A physician reported in 2013 to the FDA that a patient developed a rash in the exact shape of the C-Qur mesh.
In 2014, another patient notified the FDA they experienced hives, rash, and redness after implantation of the C-Qur hernia mesh.
Then in 2015, another physician reported a patient experienced severe pain with a purple and blue discoloration post implant.
Once again in 2016, yet another physician reported to the FDA that a patient developed a rash after implanting the C-Qur mesh. The rash was still present eight months post implant.
These immune responses lead to a higher rate of internal infection.
FDA Warning Letter
Because of countless patient complaints, on October 11, 2012, the FDA issued a warning letter to Atrium Medical Corporation, noting that the company was failing to adequately address multiple complaints related to infections associated with the C-Qur hernia mesh. The letter also revealed that Atrium Medical Corporation appeared to be ignoring numerous sterility complaints, including at least 35 separate complaints of human hair found in medical devices that were supposed to be sterile.
The FDA’s letter also said Atrium added additional products to their sterilization load, including the C-Qur V-Patch, without adequately evaluating the additional challenges that this device may present to sterilization. Additionally, Atrium modified the temperature during the manufacturing process of the C-Qur hernia mesh without notifying the FDA.
Atrium’s defense was that their manufacturing process had suddenly started to burn some of the C-Qur hernia meshes, but did not say why this happened.
Studies published in medical have shown the device is prone to complications after 28 days.
In January 2013, a study on mesh infection rates after hernia surgery with C-Qur V-Patch stopped prematurely because of an unacceptably high rate of C-Qur infections. The results have not been published.
Another study published in November 2013, found C-Qur versus five other hernia patches showed the weakest incorporation into the body after 90 days.
A February 2016 study on the possible inflammatory of omega 3 fatty acid coating in the mesh found dense oozing adhesions after removal. The study concluded that the adhesion resulted from the coating.
Even after the FDA issued countless warning letters, requests for compliance and mounting studies, Atrium continued to market their unsafe composite mesh products.
On February 3, 2015, the FDA filed a lawsuit against Atrium fining them $6 million for noncompliance. The FDA also issued a permanent injunction. This stopped the manufacture and distribution of C-Qur hernia mesh. Production cannot resume until the FDA finds the manufacturing, processing, packing, holding and distribution of Atrium’s devices are in compliance.
Even after the injunction, C-Qur mesh continues to be used in surgeries nationwide.
The side effects from C-Qur composite mesh can be painful and difficult to treat. These are:
- Allergic reaction
- Adhesion or scar-tissue fusing together
- Intestinal blockage
- Mesh migration
- Mesh shrinking
- A hole forming in neighboring tissues or organs
If you had hernia surgery, contact your surgeon to know if he or she used C-Qur composite mesh. Also, be vigilant at monitoring the symptoms of complications found most often with the hernia mesh. If you experienced any of these symptoms, contact us today.
Speak to an Attorney Today
Doctors could have implanted an estimated 300,000 people with C-Qur composite mesh. If you or a loved one had an infection after hernia surgery, you need an attorney with experience helping people who have been harmed by pharmaceutical companies. The attorneys at the Michael Brady Lynch Firm know what it takes to go up against these manufacturers to get clients what they need.
- Failing to research Atrium C-Qur Mesh
- Not properly investigate complaints
- Failing to issue a recall
- Insufficient warnings about injury risks
- Designing and selling a defective and dangerous hernia mesh product
How We Can Help
When you experience side effects, it can have devastating effects on your entire life. In fact, you may be entitled to compensation for their injuries and damages. The types of losses that can be recovered include:
- Past and future medical expenses
- Lost wages
- Loss of an ability to work; and
- Pain and suffering
Furthermore, if a person dies from complications, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
A suit finds the conduct of a company in manufacturing and selling a product to be highly reckless, punitive damages may be awarded to punish the company and deter similar conduct in the future. If you developed an infection after hernia surgery, please speak to us to learn more about your rights.
Case evaluations are free of cost and without obligation. Therefore, call us today at (877) 513-9517 or contact us online to speak with an attorney about your options. We may be able to get you the help you need.
December 2016: The Judicial Panel on Multidistrict Litigation ruled Dec. 7, 2016, to consolidate federally-filed C-Qur mesh lawsuits before U.S. District Judge Landya B. McCafferty in the District of New Hampshire. The newly formed C-Qur Hernia Mesh multidistrict litigation (MDL) will bring similar lawsuits filed in federal court together for pretrial proceedings.
The MDL request came from plaintiff Nicole Young, who filed her C-Qur lawsuit in New Hampshire district court in May 2016. Six other plaintiffs with lawsuits pending in the state also joined Young in her request to bring all federally-filed suits to the District of New Hampshire.
Atrium Medical operates two facilities in New Hampshire. Plaintiffs argued no other district court had “as substantial of a relationship to Atrium or the product in issue” as the District of New Hampshire, according to Young’s memorandum.