Hernia mesh is a type of surgical mesh used to strengthen weakened tissues during hernia repair surgeries. The C-Qur Hernia Mesh was the first of its kind to use an all-natural Omega 3 gel coating designed to reduce the risk of inflammation and other complications. That same coating is now under scrutiny by injured patients and their lawyers, who say the gel coating incites an inflammatory response that leads to complications and injuries. Lawsuits are now being filed against the maker of C-Qur Hernia Mesh, Atrium Medical Corporation.
Lawsuits are being filed by patients who experienced hernia mesh complications from their C-Qur Hernia Mesh, manufactured by New Hampshire-based Atrium Medical Corporation. These complications include infection, inflammation and the need for a second surgery to remove the mesh.
C-Qur Hernia Mesh lawsuits accuse Atrium Medical of several legal claims, including:
Nearly 2 dozen lawsuits involving C-Qur Hernia Mesh claims were consolidated into a multidistrict litigation (MDL) in the District of New Hampshire in December 2016. U.S. District Judge Landya B. McCafferty will preside over the litigation.
The MDL was formed after 7 C-Qur Hernia Mesh plaintiffs petitioned the MDL Panel to centralize their cases. Plaintiff Nicole Young, who filed her C-Qur Hernia Mesh lawsuit in New Hampshire federal court in May 2016, was the lead petitioner. She was joined by 6 other plaintiffs with cases in the state. Atrium Medical operates at least 2 manufacturing facilities in the state of New Hampshire.
The MDL’s decision has the potential to affect all C-Qur Hernia Mesh lawsuits filed in federal courts nationwide.
Hernia mesh lawyers and attorneys were scheduled to hold their first case management conference in the newly established MDL in February 2017. Since the MDL was formed, 4 more lawsuits have been transferred to the coordinated proceedings as of March 2017 and more are expected to be filed in the future.
The C-Qur Hernia Mesh MDL is still in its early phases — no cases have gone to trial and there have been no settlements or jury verdicts awarded in any of the cases.
MDLs are different from class action lawsuits. MDLs involve individual cases that allege similar claims against a defendant and are consolidated to ease the discovery process and reduce court costs. Cases in an MDL are still tried individually and any settlements or verdicts are awarded on an individual basis, usually based on the injuries sustained by the plaintiff.
Class action lawsuits are filed by one or more individuals on behalf of others who were affected in the same way by the same defendant. Settlements and jury verdicts awarded in a class action are split equally among the plaintiffs.
Patients harmed by Atrium Medical’s C-Qur Hernia Mesh report suffering a number of side effects and complications. Hernia mesh lawyers have reported these injuries in the various lawsuits now filed in state and federal courts.
C-Qur Hernia Mesh injuries observed by lawyers and attorneys include:
Atrium Medical designed its C-Qur Hernia Mesh with a novel Omega 3 gel coating. It remains the only hernia mesh device on the market to use it and patients and attorneys claim the coating can lead to certain hernia mesh complications. They allege the gel coating incites an inflammatory response that leads to adhesions, mesh and tissue erosion, and other injuries.
Atrium Medical received clearance to market its hernia mesh product through the FDA’s 510(k) Premarket Notification process. This means C-Qur Hernia Mesh was approved without undergoing rigorous premarket clinical tests. Atrium Medical only needed to show that C-Qur was similar to other hernia mesh devices already on the market. No other hernia mesh used the Omega 3 gel coating, but C-Qur was approved through the 510(k) process nonetheless.
Hernia mesh is a type of surgical mesh used in hernia repair surgery to help support weakened or damaged tissue. A hernia occurs when an organ pushes through an opening or weakness in the surrounding tissue.
Hernias have a high rate of recurrence and surgeons often use hernia mesh to lower this risk. But studies have shown that the benefits of hernia mesh often outweigh its risks because of the many complications it can cause.
Hernia mesh can be made from synthetic material or animal tissue. Mesh made from animal tissue is eventually absorbed by the body and does not provide longterm support to weakened tissue. Mesh made from synthetic material can be either absorbable or nonabsorbable.
Nonabsorbable mesh are permanent implants intended to remain inside the body indefinitely. These synthetic materials have been shown to increase complications, especially the plastic-like material polypropylene.
C-Qur Hernia Mesh is made from polypropylene and an all-natural Omega 3 gel coating. The coating is derived from highly purified, pharmaceutical-grade fish oil. Atrium Medical was the first and only hernia mesh manufacturer to coat its product with this type of coating.
The first C-Qur Hernia Mesh was approved by the FDA in March 2006 without rigorous premarket testing. Since its initial approval, the FDA has cleared 9 other similar hernia mesh devices.
C-Qur hernia mesh products developed by Atrium Medical and approved by the FDA include:
Lawsuits involving Atrium’s C-Qur Hernia Mesh allege the device can cause numerous complications following hernia repair. Many of these patients require revision surgery to further repair or remove the faulty hernia mesh.
The lawsuits also accuse the C-Qur device of inciting an inflammatory response that can cause adhesion, improper tissue wall fixation and other severe complications.
C-Qur Hernia Mesh is associated with complications such as:
Hernia repair surgery is a common procedure in the United States — more than 1 million are performed each year. The majority of these surgeries are to repair hernias that occur in the inner groin.
There are two main methods of hernia repair surgery: laparoscopic and open repair.
This type of hernia repair is performed using small incisions in the abdomen, in which surgeons use tools to reach and repair the hernia. Laparoscopic surgery is generally associated with better surgical outcomes over open repair, since the procedure is minimally invasive.
Patients typically recover more quickly and experience less pain following laparoscopic hernia repair compared with open repair. However, at least one study has shown that patients who undergo laparoscopic hernia repair may not experience less pain following surgery and the two approaches may have comparable hernia recurrence rates.
However, this method is more costly to patients. The typical recovery time for laparoscopic hernia repair surgery is about 1-2 weeks.
In open repair, surgeons make an incision near the hernia to repair it. Patients who choose open repair may have longer recovery times compared to those who choose laparoscopic, but it may be less expensive. Recovery time for open repair is typically 3 weeks compared to 1-2 weeks for laparoscopic.
The FDA conducted a review of adverse events reports and peer-reviewed scientific literature to determine the most common complications of hernia repair surgery.
The most common adverse events, regardless if hernia mesh was used in the repair or not, were:
When a mesh is used during hernia repair, the FDA found that the most common complications were:
Hernias can be caused by a number of different factors. Most are caused by pressure pushing on a weakened spot in muscle or connective tissue, which then pushes an organ or tissue through the weak spot.
Risk factors for hernias include:
Hernias can occur in different areas of the body. The most common types of hernias are:
The most common symptom of hernias is a bulge in the area where the hernia occurred. Other hernia symptoms are possible and may depend on where the hernia is located.
Hernia symtoms include:
Atrium Medical recalled certain lots of its C-Qur Hernia Mesh and C-Qur Edge V-Patch hernia mesh in July 2013. The company initiated the recall because the devices could adhere to the inner package lining during shipping and storage if exposed to high humidity.
The FDA classified the recall as “Class II” the following August and more than 32,000 C-Qur hernia mesh and 1,500 C-Qur Edge V-Patch were taken off the market in the U.S. and abroad.
Class II recalls mean the device could cause temporary or reversible health consequences, but serious adverse health events, like death, are typically remote.
The recall was finally terminated in March 2016, but raised concerns about the safety and effectiveness of the C-Qur Hernia Mesh products. If these devices could adhere to package lining when exposed to high humidity in the air, what could they adhere to inside the humid environment of the body?
The FDA took action against Atrium Medical and its parent companies, Maquet Holding and Getinge Group, in 2015 after investigations revealed “major violations” in the companies’ manufacturing processes.
The federal agency conducted 10 inspections at Atrium’s manufacturing plant in Hudson, N.H., as well as two Maquet facilities in New Jersey and Germany between 2009 and 2013. The inspections uncovered violations of quality systems regulations, medical device reporting regulations and correction and removal regulations.
Atrium and its parent companies manufacture not only C-Qur and other hernia mesh products, but also oxygenators, catheters and life support systems. The FDA said that during the time of its inspections, the companies initiated 45 different recalls of their products. C-Qur Hernia Mesh was one of the products subject to recall during that timeframe.
The FDA sent a warning letter to Atrium Medical in October 2012, just months before the company began its recall of certain C-Qur and Edge V-Patch meshes. The agency cited cleanliness violations, including numerous accounts of hair being found in Atrium’s supposedly sterile medical devices.
Atrium was also slammed for not properly investigating complaints of infections in patients with C-Qur mesh.
In 2015, the FDA announced it was placing a permanent injunction against Atrium’s parent company Maquet and two of its top executives for repeatedly failing to correct violations.
The injunction was filed in the U.S. District Court for the District of New Hampshire, where two dozen C-Qur Hernia Mesh lawsuits are now pending in a federal MDL.
C-Qur Mesh Still in Production
The 2015 injunction is still in place against Maquet and as part of the terms Atrium halted production of C-Qur meshes at its Hudson, N.H. facility. But that didn’t stop Atrium from manufacturing the meshes altogether. Instead, the company moved production to another facility located in Merrimack, N.H. and the mesh is still sold to U.S. physicians and patients today.
Since the injunction was put in place, the FDA has granted approval of several new C-Qur hernia mesh products through its 510(k) clearance program, including the C-Qur TacShield, C-Qur FX and C-Qur Mosaic.
There have been numerous studies published in peer-reviewed medical journals that show C-Qur Hernia Mesh can cause complications. Other studies of hernia mesh in general have found that the devices are prone to complications further down the road and can cost patients up to 3 times as much in medical expenses if a faulty mesh needs to be removed.
Hernia mesh complications can often often lead to mesh removals because the injuries are so severe. A study conducted by Vanderbilt University and published in the Journal of the American College of Surgeons in January 2017 looked at the rate of hernia mesh removals and their cost to patients.
Researchers used data from patients in 3 different states — California, New York and Florida — and calculated the average cost of hernia mesh removal to patients and how long after the initial surgery the removals took place.
The average cost for hernia removals was nearly $22,000 on average, compared to less than $7,000 for non-removals. Mesh removals typically occurred less than 1 year following surgery and 90% of hernia mesh removals occurred within 3 years of the initial surgery.
A Danish study published in JAMA in October 2016 showed the risk of hernia mesh complications may outweigh the benefits of using mesh in hernia repairs. It was one of the longest and largest studies ever conducted on hernia mesh outcomes and included more than 3,200 hernia repair patients.
Researchers found that although hernia mesh reduced the risk of having to re-operate for recurrent hernias, the benefits were eventually outweighed by the risks of mesh complications.
Researchers followed up with patients 5 years after their initial surgeries and found the number of mesh-related complications was about 5.6% for patients who underwent open hernia mesh repair and 3.7% for patients who underwent laparoscopic repair. That’s compared to the 0.8% complication rate for patients who underwent hernia repair without a mesh.
Researchers reported such mesh complications as bowel perforation, fistulas, chronic surgical site infection, abscesses, non-healing wounds, collections of blood or other fluid and bowel obstruction.
They concluded that long-term assessments of medical devices are needed before determinations about their benefits can be made.
Hernia Study, 2017
A study published in the journal Hernia in February 2017 looked at the effects of C-Qur and C-Qur FX meshes in lab rats. Researchers were testing for adhesion rates and noted that surgical mesh used in hernia repair often incite inflammatory reactions that lead to adhesions between the mesh and tissue wall.
The vast majority of the rats implanted with a C-Qur or C-Qur FX mesh developed inflammation and adhesions, which researchers evaluated at 7 and 21 days after the surgery.
The study found that while C-Qur and C-Qur FX meshes reduced inflammation and adhesion in the first week after surgery, that effect was diminished by day 21.
British Journal of Surgery Study, 2012
A 2012 study published in the British Journal of Surgery tested 7 different hernia meshes in 144 lab rats to see how many resulted in infection and adhesion formation. The researchers implanted 16 of those rats with a C-Qur mesh and found 15 of the 16 rats developed infection and mesh adhesion within 90 days following surgery.
British Journal of Surgery Study, 2009
Researchers studied the effects of different meshes on inflammation and adhesion formation in lab rats. The results of their study were published in the British Journal of Surgery in March 2009.
The researchers found the C-Qur Hernia Mesh reduced inflammation for the first week after surgery, but the effects were diminished after 30 days. Researchers noted that a month after surgery, the absorbable coating on the C-Qur mesh may actually contribute to adhesion formation.
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