C-Qur Lawsuit: Who is the FDA Protecting?

C-Qur Multi District Litigation (MDL)

C-Qur Hernia Mesh Logo

On October 11, 2016, C-Qur hernia mesh lawyers filed a motion seeking to create a federal docket for all C-Qur hernia mesh cases filed nationwide. The C-Qur lawyers asserted that the District of New Hampshire is the appropriate forum for consolidation. There were 13 C-Qur lawsuits pending in federal courts at the time of the filing. 6 of the 13 C-Qur lawsuits were filed in the District of New Hampshire. The first C-Qur lawsuit filed in federal court was assigned to Judge Landya Boyer McCafferty in the District of New Hampshire. Our hernia mesh lawyers recommended Judge Landya B. McCafferty continue to preside over the entire litigation. There are now 98 C-Qur hernia mesh lawsuits filed in federal court. The MDL hearing for the C-Qur hernia mesh took place on December 1, 2016. Judge McCafferty was appointed by the MDL panel to preside over the C-Qur MDL on December 8, 2016. The C-Qur hernia mesh litigation is MDL docket number 2753. Attorney Adam Evans of the Hollis Law Firm was appointed to the C-Qur MDL executive leadership committee.

Atrium Hernia Mesh Lawsuit

Device tags for the CQur V-Patch

C-Qur V-Patch fish oil coated hernia mesh next to a quarter for size comparison.

The C-Qur hernia mesh lawsuit is against Atrium Medical Corporation for failure to warn about their defective hernia mesh. The hernia mesh lawyers at the Hollis Law Firm believe that the FDA should recall Atrium’s hernia mesh. The individual C-Qur hernia mesh lawsuits are not Atrium’s only problem. The FDA conducted several investigations into the company and eventually sued Atrium in 2015. However, the FDA has not issued a class I recall on Atrium’s C-Qur hernia mesh. In July of 2016, Atrium experienced a sudden increase in the number of lawsuits filed in Federal Court regarding the C-Qur hernia mesh. Our hernia mesh lawyers continue to receive frequent reports of injuries associated with Atrium’s C-Qur hernia mesh. A number of hospitals and surgeons around the country continue to implant Atrium’s C-Qur mesh.

Many surgeons and hospitals have recently stopped implanting the C-Qur hernia mesh due to high rates of infections, bowel obstructions, and allergic reactions to the fish oil coating on the C-Qur mesh. The C-Qur mesh is very difficult to remove once it attaches to the bowel.

FDA Approval of Atrium’s C-Qur Hernia Mesh

The FDA approved Atrium’s C-Qur hernia mesh (pronounced “Secure”) in March of 2006. Atrium used the FDA 510(k) approval program for the C-Qur mesh. The 510(k) approval program allows companies to skip rigorous pre-market research and studies. The C-Qur hernia mesh was allowed to be marketed for being similar to a mesh approved in the 1990’s. However, Atrium’s C-Qur hernia mesh is the first mesh to ever utilize an omega 3 fatty acid coating. Products approved via the 510(k) process are susceptible to lawsuits, unlike products that undergo extensive testing for Pre-Market Approval (PMA).

Close up view of the sticky fish oil on the C-Qur V-Patch hernia mesh

C-Qur Hernia Mesh Uses

The C-Qur hernia mesh is utilized for more than just ventral and inguinal hernias. Surgeons also use the mesh for chest wall reconstruction, as well as traumatic and surgical wounds. Atrium advertises the C-Qur as having an all-natural Omega 3 fatty acid (O3FA) gel coating. A highly purified pharmaceutical grade fish oil consisting of a unique blend of triglycerides, O3FA, and many other substances actually coat the mesh. The Atrium C-Qur hernia mesh lawsuit alleges problems with the O3FA coating.

Atrium C-Qur Hernia Mesh Injuries

The Hollis Law Firm’s mesh lawyers have observed the following injuries & complications related to the C-Qur:

  • Infection: A very high rate of infections. Infection can remain dormant for months.
  • Rejection: An abnormally high rate of rejection.
  • Organ Perforation: A hole can form in an organ, such as the intestines, when coming in contact with parts of the C-Qur mesh.
  • Foreign Body Response: Inflammation and encapsulation of the foreign body (C-Qur mesh) with scar tissue.
  • Chronic Pain: A high rate of intense pain once implanted until explanted.
  • Additional Surgeries: Unfortunately, many clients have required multiple surgeries to remove the entire C-Qur mesh.
  • Rash: A rash covering the abdomen and other parts of the body. Rash disappears when C-Qur mesh removed.
  • Neurological Changes: Poor memory and concentration.
  • Dental Problems: Many patients who suffer from a chronic mesh infection develop severe dental problems. Many patients have lost all of their teeth.
  • Bowel Obstruction: Dense adhesions form connecting the C-Qur mesh to the bowel. Beware of a change in bowel habits.
  • Abnormal Liver Function: Many patients have had unexplained abnormal liver function test.

The Atrium C-Qur hernia mesh lawsuit includes all injuries.

Business Deals with Atrium and the C-Qur Hernia Mesh

Product Identification Sticker for CQur Hernia Mesh

C-Qur Hernia Mesh Deal with Premier

Posterior view of Atrium Medical's C-Qur VPatch hernia mesh

Premier, Inc. (Charlotte, North Carolina) awarded Atrium a three-year national contract on August 10, 2010. Premier is a group purchasing organization, which purchases medical devices in bulk. Atrium’s three-year contract was for surgical mesh. Atrium provided the C-Qur hernia mesh to Premier’s Accelerated Supply Chain Endeavor (ASCEND) program member-participants (hospitals). The ASCEND program even further reduces hospital cost through specially negotiated contracts.

Premier noted that members of its healthcare alliance would “have access to specially negotiated pricing and terms for Atrium’s surgical mesh products, including Atrium’s first-to-market Bioabsorbable Omega 3 Fatty Acid (O3FA) coated surgical mesh, C-Qur.” Atrium’s contract to supply the C-Qur hernia mesh was effective October 1, 2010. Suddenly, the obscure C-Qur hernia mesh shipped nationwide, because of its low cost.

Atrium Acquired by Maquet

One year later on October 3, 2011, Atrium Medical Corporation announced that it had signed an agreement to be acquired by Maquet Cardiovascular, a subsidiary of the Getinge Group for $680 million. The Getinge Group’s 2011 annual report noted that Atrium had recently started producing the C-Qur hernia mesh and that Atrium experienced an average annual organic growth of 19% over the three prior years. Maquet and the Getinge Group were now responsible for producing the C-Qur hernia mesh for the remaining two years of the Premier contract. Just a week later, Maquet signed a contract with Premier to provide even more medical devices.

Atrium’s Marketing of the C-Qur Hernia Mesh

Product identification tags for the CQur Mosiac hernia mesh

On May 25, 2016, Ethicon sent a worldwide letter to doctors recalling their hernia repair product Physiomesh. A few weeks later on June 7, 2016, Getinge and Maquet, the parent companies of Atrium, sent a letter to doctors trying to convince them to switch to the C-Qur hernia mesh. Getinge stated that they wanted doctors to have the C-Qur hernia mesh available to “minimize any impact on patients.” If Getinge really wanted to “minimize any impact on patients” they would recall the entire C-Qur hernia mesh product line.

FDA Action Against Atrium and the C-Qur Hernia Mesh

Device Tags for CQur Edge hernia mesh

FDA Warning Letter to Atrium Medical Corporation

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 noted that 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.

Atrium also got in trouble from the FDA for modifying the temperature during the manufacturing process of the C-Qur hernia mesh. Atrium’s defense was that their manufacturing process had suddenly started to burn some of the C-Qur hernia meshes. Atrium did not provide an answer for why their C-Qur hernia mesh suddenly began to burn during the manufacturing process.

Fish oil coated mesh stuck to package linerFDA Class II Recall of Atrium’s C-Qur Hernia Mesh

On August 9, 2013, the FDA announced a class 2 recall of the C-Qur Edge mesh because the Omega 3 fatty acid coating on the mesh could adhere to the inner packaging liner due to exposure to high humidity. The recall affected 1,501 C-Qur hernia meshes. Atrium warned physicians to inspect the C-Qur mesh to insure that it was intact before implanting, but Atrium did not pull any of the C-Qur meshes off the shelf. Our hernia mesh attorney’s believe that the coating of the C-Qur mesh can also peel off once implanted, resulting in significant injuries.

FDA Injunction Against Atrium and the C-Qur Hernia Mesh

On February 3, 2015, the United States of America, on behalf of the United States Food and Drug Administration, filed the lawsuit USA v Atrium Medical Corporation in the district court of New Hampshire. The FDA lawsuit alleged that Atrium introduced adulterated medical devices into interstate commerce. The FDA noted that Atrium’s methods of manufacturing, packing, storing and installing were not in conformity with the current good manufacturing practice requirements for medical devices.

The next day the FDA issued a permanent injunction, stopping the manufacture and distribution of the C-Qur hernia mesh at Atrium’s Hudson facility. The FDA Office of Compliance stated that “Patients must be assured that medical devices are safe, effective, and high quality.” Production of the Atrium C-Qur mesh will not be allowed to resume until the FDA finds that the manufacturing, processing, packing, holding, and distribution of devices are in compliance. The FDA noted that it will “remain vigilant in bringing companies that do not meet our regulatory requirements back to a sustainable state of compliance.”

Is The FDA Aware that the C-Qur Hernia Mesh’s Fish Oil Coating is Defective?

Atrium advertises the fish oil coating of the C-Qur hernia mesh as being biocompatible and effective at preventing adhesions to the patient’s underlying organs. However, the fish oil coating of the C-Qur hernia mesh is ineffective at preventing dense adhesions to underlying organs. Dense adhesions to the mesh can cause bowel obstructions, and result in the C-Qur mesh contracting and folding over on itself. The fish oil coating also is not biocompatible and frequently causes rashes, rejection, allergic reactions, and severe infections. Below are some of the more notable FDA adverse event reports regarding the fish oil coating of Atrium’s C-Qur hernia mesh. (The FDA’s entire online adverse event reporting database crashed as soon as we started exposing hernia mesh adverse event reports. That’s okay though, we are in the process of uploading and attaching PDF versions of all the adverse event reports).

Types of Atrium C-Qur Hernia Mesh

Physicians utilize several different types of C-Qur mesh for various abdominal procedures.

  • C-Qur: The original Omega 3 fatty acid hernia mesh for open and laparoscopic hernia repair.
  • C-Qur Edge: The only C-Qur hernia mesh to be recalled.
  • C-Qur V-Patch: Mesh for the repair of small hernias such as umbilical, epigastric and trocar site defects.
  • C-Qur Tacshield: Mesh for the surgical repair of medium to large size open ventral hernia repairs.
  • C-Qur FX: Mesh for open and laparoscopic hernia repair.
  • C-Qur CentriFX: See-thru clarity mesh designed for lateral and medial hernia defects.
  • C-Qur Mosaic: See-thru clarity mesh for open and laparoscopic hernia repair.
  • C-Qur Film: Intended as an adjunct in abdominal and pelvic surgery to reduce the incidence, extent and severity of postoperative adhesions.

CQur VPatch fish oil coated hernia mesh by Atrium Medical.How to Alert the FDA About Atrium C-Qur Hernia Mesh Complications

Even after the FDA lawsuit, the C-Qur hernia mesh continues to be implanted and is causing severe injuries nationwide. The FDA is still not fully aware of how high the rate of adverse events are with the C-Qur hernia mesh. Unfortunately, most physicians and hospitals do not submit their own adverse event reports to the FDA, because it takes too much time and effort. Patients can submit their own adverse event reports to the FDA regarding the C-Qur hernia mesh, but the companies and the FDA don’t always give patient submissions the same weight as physician submissions. Another option is to file a lawsuit. As with all medical devices, anytime a lawsuit is filed regarding the device, the company is mandated to notify the FDA of the lawsuit and file a corresponding adverse event report. In many litigations, the number of adverse events reports increase by 10 to 100 times after lawsuits are filed. The current FDA adverse event tracking and reporting system is broken, because physicians and medical device companies are not properly incentivized and penalized for reporting and/or under-reporting complications.

Scientific Articles on the C-Qur Hernia Mesh

Device tags for CQur FX hernia mesh

February 2016: Inflammatory Reaction to Fish Oil Coated Polypropylene Mesh Used for Laparoscopic Incisional Hernia Repair: A case report.

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.

October 2014: Biaxial Analysis of Synthetic Scaffolds for Hernia Repair Demonstrates Variability in Mechanical Anisotropy, Non-Linearity and Hysteresis.

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.

2014: In Vivo Comparison of Marketed Biologically Augmented Hernia Grafts.

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.

November 2013: Coated Mesh for Hernia Repair Provide Comparable Intraperitoneal Adhesion Prevention.

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.

February 2012: A Review of the Composition, Characteristics, and Effectiveness of Barrier Mesh Prostheses Utilized for Laparoscopic Ventral Hernia Repair.

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.

December 2011: Biomechanical Evaluation of Potential Damage to Hernia Repair Materials Due to Fixation with Helical Titanium Tacks.

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.

HOW DO I KNOW IF I HAVE AN ATRIUM C-QUR HERNIA MESH LAWSUIT?

We cannot answer that question without speaking to you personally, as no two people or lawsuits are the same. Please call us to speak to one of our trained team members. An attorney and a medical professional will look over your case and let you know what they believe the best course of action is for you. The Hollis Law Firm does not handle class actions. Each claim is an individual lawsuit. The specific facts of your lawsuit will determine if your lawsuit is compensable and to what amount. The Hollis Law Firm represents clients and files hernia mesh lawsuits nationwide. All case evaluations and consultations are FREE, CONFIDENTIAL, and carry NO RISK or OBLIGATION. Call (800) 701-3672 for an Atrium C-Qur hernia mesh lawsuit evaluation. Follow our C-Qur Lawsuit FaceBook page to stay up-to-date on the latest C-Qur litigation updates.

 

Content Created By:

C. Brett Vaughn RN, BSN, JD

Want even more information on the C-Qur hernia mesh?

Check out C. Brett Vaughn’s article on the C-Qur at MeshMedicalNewsDesk.

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