Atrium

Introduction

FDA Clearance of Atrium’s C-Qur Hernia Mesh

The FDA cleared Atrium’s C-Qur hernia mesh (pronounced “Secure”) in March of 2006. Atrium used the FDA 510(k) clearance program for the C-Qur mesh. The 510(k) clearance 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).

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.

C-Qur Hernia Mesh Deal with Premier

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

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 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.

FDA 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.

History of the Case

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 Atrium hernia mesh lawsuit USA v Atrium Medical Corporation in the district court of New Hampshire. The FDA Atrium hernia mesh 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).

• Apr 2016: C-Qur Tachshield FDA Adverse Event Report MDR# 5555054 “It was reported by a surgeon that his patient had a skin reaction after implant of a surgical mesh… Eight months post procedure the patient returned tot he physician’s office with a rash that he thought was at the edge of the implanted mesh.”
• Apr 2016: C-Qur Mosiac FDA Adverse Event Report MDR# 5574515 “Patient needed mesh removed due to infection. Doctor reported that the patient had infection at two port entries and behind the muscle in front of the mesh.”
• Jan 2016: C-Qur V-Patch FDA Adverse Event Report MDR# 5390825 “Patient came back to hospital complaining about pain. Doctor said that after investigation and inspection of mesh there was puss surrounding mesh implant and it was infected. Mesh was removed. Testing was done on mesh revealed e. Coli.”
• Jan 2016: C-Qur Mesh FDA Adverse Event Report MDR# 5347324 “The mesh had an omega 3 onlay barrier which caused a reaction. A clot formed, skin changed color, and the end result was surgical removal of the mesh.”
• Jan 2016: C-Qur Mesh FDA Adverse Event Report MDR# 5393805 “Approximately one year later patient’s body rejected mesh requiring removal of mesh.”
• Nov 2015: C-Qur Mesh FDA Adverse Event Report MDR# 5201119 “Device Problem Material deformation” “Patient had laparoscopic hernia repair approximately one year ago. Three months ago there was a query of immunodeficiency and lupus so the patient was put on steroids. Patient developed wound complications, cellulitis, abdominal pain and discharge. Surgeon took patient back into the operating room and mesh was completely intact with no incorporation into surrounding tissue. Described mesh as being like it was tofu/green in color and lumpy. Mesh was removed. Pathology on mesh and tofu-like substance came back as sterile.”
• Aug 2015: C-Qur Mesh FDA Adverse Event Report MDR# 5015091 “While implanting mesh into the patient a half piece of plastic lining was also implanted.
• Aug 2015: C-Qur V-Patch FDA Adverse Event Report MDR# 5001769 “C-Qur V-Patch was explanted due to a suspicion of a chronically infected mesh. Cultures revealed scant growth of s. Lugdunensis which requires aggressive treatment in order to prevent more significant complications and s. Epidermidis which is part of normal human flora.”
• Jul 2015: C-Qur V-Patch FDA Adverse Event Report MDR# 4942097 “Infection from mesh that had to be explanted. Cultures were done on explants and they showed skin flora along with other bacteria.”
• Jul 2015: C-Qur Mosiac FDA Adverse Event Report MDR# 4947144 “While suturing, the omega-3-fatty-acid coating started flaking off.”
• Jun 2015: C-Qur V-Patch FDA Adverse Event Report MDR# 4849867 “Patient began complaining of “severe pain” and a purple/blue discoloration on and around her incision/scar.”
• Jun 2015: C-Qur Mesh FDA Adverse Event Report MDR# 4811381 “Further surgeries due to pain, adhesions and mesh rejection.”
• Jun 2015: C-Qur V-Patch FDA Adverse Event Report MDR# 4867643 “Physician did a surgery laparoscopically to repair a recurrent hernia and found the previously placed mesh had retracted, shrunk, and was hard.”
• May 2015: C-Qur Mesh FDA Adverse Event Report MDR# 4792730 “Mesh became intertwined with intestines, bowel, and adhered to colon”
• May 2015: C-Qur Mesh FDA Adverse Event Report MDR# 4788007 “Pt had mesh implanted to repair an umbilical hernia and it failed to incorporate into the tissue and the pt’s body rejected it and it had to be removed.”
• Apr 2015: C-Qur Mosiac FDA Adverse Event Report MDR# 4729587 “The physician reported that in the course of implanting a mesh the coating was falling off while attempting to tack the mesh. The mesh started to tear.”
• Mar 2015: C-Qur V-Patch FDA Adverse Event Report MDR# 4634829 “Pt was implanted with a mesh in [sic] and eight months later there was a wound infection that would not heal. Mesh was explanted.”
• Mar 2015: C-Qur Mesh FDA Adverse Event Report MDR# 4619369 “The physician reported that in the course of implanting mesh, the coating was falling off while attempting to tack the mesh.”
• Feb 2015: C-Qur V-Patch FDA Adverse Event Report MDR# 4540575 “Had a lot of pain post op-hives, rashes, redness, swelling at site within 8 days of implant, temp increase with wbc 2300 by day 10 post op.”
• Feb 2015: C-Qur V-Patch FDA Adverse Event Report MDR# 4524395 “Doctor noticed the mesh had hardened and mass around the area where mesh had been”
• Jan 2015: C-Qur Mesh FDA Adverse Event Report MDR# 4479484 “Surgeon said that it looked “like a bomb went off inside” and tissue looked like “third degree burns.”
• Dec 2014: C-Qur Mesh FDA Adverse Event Report MDR# 4330606 “Removed a round hard object which was later identified as the atrium c-qur mesh. The surgeon determined the mesh failed to incorporate into my surrounding tissue due to extended delay caused by the properties and design of the barrier, resulting in the removal of the atrium c-qur mesh. The hospital pathology lab determined the mesh was rejected because of foreign body response.”
• Nov 2014: C-Qur V-Patch FDA Adverse Event Report MDR# 4249817 “The pt complained of ongoing pain and discharge from the umbilicus and that the mesh was protruding from the skin. The pt trimmed the mesh himself and the symptoms continued. A diagnostic laparoscopy was performed and a small loop of bowel lightly adhered to the mesh was noted. The surgeon took down the adhesion and noticed pus between the abdominal layers so he removed the device via the umbilicus. The product was cultured for infection and the results were negative.”
• Oct 2014: C-Qur Tachshield FDA Adverse Event Report MDR# 4196077 “Patient presented with fistula and adhesions after mesh placement.”
• Oct 2014: C-Qur Tachshield FDA Adverse Event Report MDR# 4196032 “Patient presented with fistula and hernia recurrence.”
• Jun 2014: C-Qur Mesh FDA Adverse Event Report MDR# 3894007 “Previous repair was 3 years ago with mesh 12.5cm x12.5cm and permanent sutures and tacks. At re-operation, mesh had contracted to 5cm x 10cm. The mesh was removed.”
• Jun 2014: C-Qur V-Patch FDA Adverse Event Report MDR# 3875024 “An infection presented several weeks after the mesh was implanted, and the mesh was removed. Deep tissue was cultured and determined to be infected.”
• May 2014: C-Qur Mesh FDA Adverse Event Report MDR# 3839069 “During an unrelated abdominal surgery a surgeon noticed that there were adhesions to the mesh placed 18 months prior.”
• May 2014: C-Qur V-Patch FDA Adverse Event Report MDR# 3916073 “Hospital reported that during insertion of mesh in patient, the ring within the mesh buckled and folded upwards.”
• Dec 2013: C-Qur Mosiac FDA Adverse Event Report MDR# 3538702 “Patient presented a rash one week later… The rash was the exact shape of the mesh.”
• Jul 2013: C-Qur Mesh FDA Adverse Event Report MDR# 3231514 “Surgeon reported bowel obstruction immediately after implantation.”
• Aug 2013: C-Qur Mesh FDA Adverse Event Report MDR# 3282516 Three days after implantation “during the second procedure noticed that a large portion of the adhesion barrier had simply fallen off of the mesh and was resting on the bowel.”
• Aug 2012: C-Qur Edge FDA Adverse Event Report MDR# 2685202 “Surgeon unable to fully extract infected mesh which caused or contributed to a significant small bowel obstruction.” The patient died.
• May 2008: C-Qur Mesh FDA Adverse Event Report MDR# 1038011 One year after implantation “Extensive intra-abdominal adhesions were noted. The previously placed mesh was noted to be severely contracted and thickened.”

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.

How to Alert the FDA About Atrium C-Qur Hernia Mesh Complications

Even after the FDA Atrium hernia mesh 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 an Atrium hernia mesh 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.

Injuries Related to Product

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 hernia mesh lawsuit includes all injuries.

Additional Literature

2018

June 2018: Infection and Recurrence Rates of the C-Qur V-Patch in Ventral Hernia Repairs.

Nearly 200 patients were implanted with the C-Qur V-Patch by a single surgeon. 19% of C-Qur V-Patches implanted intra-peritoneally became infected. Wound cultures tested positive for Staphylococcus Aureus, Methicillin-Resistant Staphylococcus Aureus, Staphylococcus Lugdunenis, and Serratia marcesens. Infections even presented as late as 4 – 12 months after implantation of the C-Qur V-Patch. All patients with late onset infections were unable to be successfully treated with oral antibiotics. The authors noted that “there may be reason for concern regarding the C-QUR V-Patch Mesh itself. There is anecdotal evidence from other surgeons that this may be the case, and it is thought that the fish oil backing could be implicated.”

2016

August 2016: Evaluation of Long-Term Surgical Site Occurrences in Ventral Hernia Repair: Implications of Preoperative Site Independent MRSA Infection.

632 patients were studied for two years after being implanted with hernia mesh. 31% experienced complications within just two years. Complications included cellulitis, necrosis, nonhealing wound, seroma, hematoma, dehiscence, and fistula. Patients with a preoperative MRSA+ infection from any site (urine, blood, surgical site), might be at an elevated risk for hernia mesh complications.

August 2016: Oral, Intestinal, and Skin Bacteria in Ventral Hernia Mesh Implants.

36 patients with failed hernia mesh were studied. All participants were found to have gingivitis and 33% had infected gums and teeth. Oral bacteria was discovered on 43% of explanted hernia mesh. The study discusses the difficulty in knowing the real rate of hernia mesh infections, due to lack of standardized criteria to define infection, lack of follow-up exams, and lack of intervention when complications arise. It notes that hernia mesh infection is the most common reason for mesh removal.

June 2016: Sepramesh and Postoperative Peritoneal Adhesions in a Rat Model.

The study notes that “postoperative peritoneal adhesions occurred at the extremities of the mesh, where there was close contact between the polypropylene and viscera, or where the fixation suture was placed.”

2014

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.

2013

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.

2012

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.

2011

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.

2009

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.

surface area of the abdominal wall is stretched by about 80% during laparoscopic repair. Surgeons must anticipate significant mesh shrinkage in laparoscopic hernia repair. Mesh shrinkage remains one of the unsolved problems of laparoscopic incisional hernia repair.