C-QUR Problems May Require Revision Surgery
C-QUR (pronounced “secure”) may be used in hernia surgeries and other soft tissue surgical repair procedures, including reconstruction of the chest wall and repairing traumatic or surgical wounds.
Surgical meshes are supposed to provide permanent reinforcement to soft tissue. But this has not always happened with C-QUR meshes.
One patient, who underwent revision surgery nine weeks after being implanted with a C-QUR mesh, was reported to the U.S. Food and Drug Administration (FDA) as having his mesh “very, very poorly incorporated.” His surgeon had to remove previously healthy tissue, including muscle, to repair the damage.
Atrium’s C-QUR meshes have been used in a surgical technique called intraperitoneal onlay mesh (IPOM), where surgical mesh comes in direct contact with the intestines. Meshes used in IPOM surgeries ostensibly are intended to adhere to the abdominal wall, but not to the intestines. However, there have been reports of C-QUR meshes attaching to the intestines, causing bowel obstructions and requiring surgery to remove and replace the device.
People who have had revision surgery or have such surgery recommended by a doctor because of a problematic Atrium C-QUR mesh may be eligible for compensation for medical expenses, lost wages, and other costs.
For a free consultation and more information about your legal options, please contact us today.
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Weitz & Luxenberg is taking C-QUR mesh cases and is interested in talking to people in the U.S. who have had revision surgery – or have one scheduled – due to complications resulting from the use of C-QUR mesh. The firm is also interested in talking with people who have experienced pain or other mesh-related symptoms after being implanted with an Atrium C-QUR mesh.
C-QUR Mesh Complications
The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database lists hundreds of reports filed by doctors, patients, and the manufacturer addressing potential C-QUR mesh-related problems.
Reports of complications from the mesh have included:
- Adhesion of the mesh to bowels
- Bowel obstructions
- Severe pain
- Seroma – a buildup of fluid under the skin
- Severe allergic reactions
Adverse event reports sent to the FDA detail many of these complications and reasons for revision surgery.
One patient needed revision surgery just 12 days after receiving a C-QUR TacShield Mesh. The adverse event report states the device had attached itself to “several loops of small intestine.”
In a 2012 surgery, a patient’s C-QUR mesh was found to have “totally detached” and “wrapped around a series of colons [sic] and ‘strangled’ them.”
Another patient spent five days in the hospital due to complications from his C-QUR mesh. After an infection developed post-implantation, the mesh had to be removed, drains had to be placed, and the patient had to be on antibiotics. Doctors then discovered a bowel obstruction after this revision surgery, which required additional surgery. The patient reporting his own adverse event to the FDA stated he felt “if he wasn’t as strong as he was, he would not have made it.”
In yet another case, a woman returned to the hospital just six hours after being discharged after having a C-QUR mesh implanted. She reported her doctor told her that she was having a “reaction or rejection to the mesh” and she needed revision surgery to remove the mesh. She reported her surgeon said the area around the C-QUR mesh “looked like a bomb went off.”
At least one lawsuit against Atrium claims the company failed to warn of potential allergic and immunologic reactions to its C-QUR meshes’ fish oil derivatives.
Holding Corporations Accountable
The FDA first approved Atrium C-QUR mesh in 2006 after the company sought approval from the agency via its 510(k) process. Devices approved through this method do not have to undergo clinical trials for safety or efficacy. Manufacturers only need to assert their device is “substantially equivalent” to a previously approved device, a “predicate” the FDA has already cleared to be marketed. Even though other surgical meshes were on the market at the time Atrium introduced C-QUR, none used a coating made in part from fish oil derivatives.
Since 2006, there have been many different products in the C-QUR mesh line, all of which have been approved for marketing through the 510(k) process.
As early as 2008, the FDA was receiving reports of problems with Atrium C-QUR meshes. The agency conducted inspections of Atrium’s New Hampshire medical device manufacturing facility, which produces C-QUR meshes, among other medical devices, in 2009, 2010, 2012, and 2013. Each time, inspectors reported violations of and deviations from federal regulations establishing good manufacturing practices for medical device manufacturing, monitoring, and reporting.
In 2012, the FDA sent a Warning Letter to Atrium citing adulteration of certain medical devices after an inspection, meaning “the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation” were “not in conformity” with “Current Good Manufacturing Practice (CGMP) requirements.” Inspectors noted “[f]ailure to review, evaluate and investigate any complaint involving the possible failure of a device, labeling or packaging to meet any of its specification” such as failure to obtain culture results on C-QUR meshes associated with infections, and failure to appropriately document lot numbers on other mesh infection complaints.
In the same Warning Letter, the FDA also noted Atrium had failed to “establish and maintain procedures for changes to a specification, method, process or procedure, and to verify, or where appropriate, validate the change…before implementation,” including increase in conveyor speed for the manufacturing of the C-QUR meshes “without completing any studies to demonstrate that this process change does not affect the finished device.”
In 2013, Atrium announced a recall of more than 1,500 units of C-QUR Edge mesh products. The company cited “excessive humidity for an extended period of time” as the reason for the potential for the C-QUR Edge mesh coating to stick to its “inner handling sleeve.”
A fourth series of FDA inspections of Atrium’s New Hampshire facility in 2013 found similar violations to “observations FDA made in separate inspections in September 2012, March 2010, and March 2009.” These uncorrected violations spurred the agency to take legal action against the company. The FDA and Department of Justice sought a permanent injunction against the manufacture of C-QUR mesh products in 2015.
Under a consent decree, the defendants agreed to pay the United States $6 million. They also agreed to pay an additional $6 million unless they:
- Received FDA authorization to resume operations at the facility “and/or”
- Transferred operations to another location
Combining C-QUR Lawsuits
In December 2016, 13 lawsuits from around the country were combined into a multidistrict litigation (MDL). MDLs can potentially speed up the process of handling complex cases.
Cases were consolidated as In Re: Atrium Medical Corp. C-QUR Mesh Products Liability Litigation MDL No. 2753 in the District of New Hampshire federal court, the state where Atrium has a production facility and offices. There were also at least eight other lawsuits pending in eight other districts at the time the MDL was created, dealing with problems alleged to have been caused by C-QUR meshes.
Cases were consolidated as In Re: Atrium Medical Corp. C-QUR Mesh Products Liability Litigation MDL No. 2753 in the District of New Hampshire federal court, the state where Atrium has a production facility and offices.
How Weitz & Luxenberg Can Help
Weitz & Luxenberg is currently accepting cases from patients who required revision surgery – or have one scheduled – because of complications from Atrium C-QUR mesh. The firm is also interested in talking with anyone who suffered pain, infection, or other mesh-related symptoms or complications.
If you have been harmed by Atrium C-QUR mesh, a knowledgeable attorney can help you understand your options. You may be entitled to compensation for medical expenses, lost wages, and other costs.
Weitz & Luxenberg can provide a free consultation to discuss your legal options. Contact us at (877) 680-3753 now, or use the online form on this page and one of our representatives will contact you shortly.