According to the U.S. Food & Drug Administration, hernia repairs are common—more than one million hernia repairs are performed each year in the U.S. Approximately 800,000 are to repair inguinal hernias and the rest are for other types of hernias. Atrium, owned by Maquet Cardiovascular, first introduced C-Qur Hernia Mesh patch (pronounced “Secure”) in 2005, through the U.S. Food & Drug Administration’s controversial 510(k) approval system, which allowed the medical device to be introduced without rigorous pre-market research and studies. The C-Qur Mesh line of products are constructed from a polypropylene mesh and advertised as having an “all-natural” Omega 3 gel coating. In fact, the coating is derived from a highly purified pharmaceutical grade fish oil consisting of a unique blend of triglycerides and Omega 3 fatty acids and not validated as “beneficial” in any clinical studies prior to release.
Despite signs of potential problems with the C-Qur Mesh design, Atrium introduced a variety of products for use in hernia repair , chest wall reconstruction and treatment of traumatic or surgical wounds, including:
- the Atrium C-Qur Mesh
- the Atrium C-Qur Mosaic
- the Atrium C-Qur TacShield
- the Atrium C-Qur V-Patch
- the Atrium C-Qur Centrifx
- the Atrium C-Qur FX Mesh (formerly the Atrium C-Qur Lite)
Recently, a study conducted in Belgium had to be stopped due to an unacceptably high rate of infections with the Atrium C-Qur V-Patch. Another study, published in the British Journal of Surgery, experienced infections in nearly every C-Qur hernia mesh that was implanted; 15 of 16 patients.
Scroll down for more Scientific Articles on C-Qur Hernia Mesh
It is believed the purported “all-natural” Omega 3 gel coating actually causes severe complications, inciting an inflammatory response that results in serious, debilitating problems, including:
- Abdominal Pain
- Chronic Infections
- Mesh Erosion
- Mesh Migration
- Mesh Folding
- Mesh Failure
- Hernia Recurrence
- Need for Revision Surgery
- Adhesions (scar-like tissue that sticks organs together)
- Bowel Perforation
- Bowel Adhesion
- Bowel Obstruction
- Organ Perforation
- Seromas (fluid buildup under the skin)
- Nerve damage
- Impotence or Urinary Problems in Men
Although many healthcare providers have discontinued using the C-Qur Mesh patches, some continue to utilize the product for hernia repairs. In fact, a few weeks after Ethicon’s May 25, 2016, letter to physicians worldwide recalling their “Physiomesh”hernia repair products, Maquet, the parent companies of Atrium, sent a letter to doctors trying to convince them to switch to their C-Qur hernia mesh patches!
If you or a loved one have had hernia surgery in which an Atrium C-Qur Mesh Patch was implanted and suffered infections, mesh adhesion, ulcers or other complications, or have required revision/”recurrence” surgery, or are in need of surgery, contact us online or call us at 1-866-252-3535.
61 year old female implanted with a C-Qur hernia mesh. Patient presented with pain and shortness of breath 3 months after implantation. Symptoms continued to progress and at 10 months a hard mass could be felt in her abdomen. Upon removal of Atrium’s C-Qur hernia mesh, dense oozing adhesions were observed around the entire mesh. It was determined that the dense oozing adhesions were the result of a foreign body reaction to the O3FA coating of the C-Qur mesh. The patient required the hernia mesh to be removed and part of her bowel.
The mechanical properties of 13 hernia mesh products were evaluated. Significant differences were observed depending what mesh was implanted and how it was secured. The authors note that hernia mesh materials are currently utilized as if they are uniform and interchangeable, when that is clearly not the case. Additional research and training on specific hernia mesh products is needed to ensure successful hernia repair.
5 commonly used hernia mesh products were compared. Atrium’s C-Qur hernia mesh was the only mesh that did not adequately support fibrovascular integration with the host tissue. Without proper integration, the mesh is at risk for migration or folding up inside the patient.
5 types of hernia mesh were studied for 90 days. Overall, uncoated polypropylene performed significantly worse, resulting in more adhesions. Coated meshes resulted in adhesions where the sutures exposed polypropylene. Of the coated hernia meshes, the C-Qur showed the weakest incorporation.
January 2013: Case-control Study of Mesh-infection after a Size Tailored Hernia Repair with C-Qur V-Patch.
The study was stopped prematurely because of an unacceptably high rate of C-Qur hernia mesh infections. The full results of the study have never been published. The authors anticipated conducting a new study to look back at the over-all incidence of infection associated with Atrium’s C-Qur V-Patch. To date, the authors have not released any additional findings related to Atrium’s C-Qur hernia mesh.
December 2012: Experimental Study on Synthetic and Biological Mesh Implantation in a Contaminated Environment.
8 different types of commonly utilized hernia mesh were implanted in 144 rats. Atrium’s C-Qur hernia mesh was implanted in 18 rats. Two of the C-Qur hernia mesh rats died before the mesh could be explanted. Of the 16 remaining rats with the C-Qur hernia mesh, 15 developed a hernia mesh infection. Three other brands of hernia mesh experienced 0 infections. Two other brands of hernia mesh experienced 1 infection. Another hernia mesh product known as Dualmesh experienced infections in 7 of out 15 rats implanted. Atrium’s C-Qur hernia mesh experienced more infections than all other brands of hernia mesh combined! Atrium’s mesh is the most infectious hernia mesh on the market.
Atrium’s C-Qur hernia mesh and other absorbable barrier hernia mesh products were studied. The study concluded that it is likely that the components of the barriers cause a wide range of inflammatory responses, resulting in dense adhesions. The authors noted that clinical trials are needed to determine to effectiveness of the C-Qur and other barrier hernia mesh products.
14 commonly used hernia mesh products were evaluated. Atrium’s C-Qur hernia mesh exhibited decreased strength when compared to other hernia mesh products. Securing the hernia mesh with various types of tacks negatively impacted the C-Qur mesh. Atrium does not warn or instruct on the proper tacks to use when securing the C-Qur hernia mesh. The C-Qur mesh has also been known to tear and fold up after implantation.
May 2011: Physicomechanical Evaluation of Absorbable and Nonabsorbable Barrier Composite Meshes for Laparoscopic Ventral Hernia Repair.
7 commonly utilized hernia mesh products were compared. Significant differences were observed between mesh types and due to the orientation of the mesh during testing. The Hollis Law Firm’s Atrium hernia mesh attorneys believe that Atrium failed to instruct surgeons on the proper orientation of the C-Qur hernia mesh.
March 2009: Degradation of Mesh Coatings and Intraperitoneal Adhesion Formation in an Experimental Model.
The study notes that it is the first time Atrium’s C-Qur hernia mesh had been described in literature (after 3 years of being on the market). Every C-Qur mesh was observed to have a significant increase in adhesions together with phagocytosis (an immune response) after being implanted for 30 days.