Atrium C-Qur Hernia Mesh Lawsuit Complications & Recall
People harmed by the C-Qur hernia mesh are filing lawsuits against its manufacturer Atrium Medical, alleging the company negligently designed, manufactured and marketed its novel hernia mesh. The lawsuits seek compensation for personal injury and economic loss, including medical bills and lost wages. There may be large cash awards from claims and settlements for this hernia mesh.
The experienced attorneys at Hood National Law Group can help you fight for the justice you deserve if you were harmed by Atrium Medical’s C-Qur hernia mesh.
To see if your case qualifies for a C-Qur Hernia Mesh lawsuit, contact a lawyer of the Hood National legal team at 1-800-214-1010 for a free case evaluation. You can also use the form on the right-hand side of your screen.
C-Qur multidistrict litigation
[UPDATE] The Judicial Panel on Multidistrict Litigation ruled Dec. 7, 2016 to consolidate federally filed C-Qur mesh lawsuits before U.S. District Judge Landya B. McCafferty in the District of New Hampshire. The newly formed C-Qur Hernia Mesh multidistrict litigation (MDL) will bring similar lawsuits filed in federal court together under one roof for pretrial proceedings.
The MDL request came from plaintiff Nicole Young, who filed her C-Qur lawsuit in New Hampshire district court in May 2016. Six other plaintiffs with lawsuits pending in the state also joined Young in her request to bring all federally filed suits to the District of New Hampshire.
Atrium Medical operates two facilities in New Hampshire. Plaintiffs argued no other district court had “as substantial of a relationship to Atrium or the product in issue” as the District of New Hampshire, according to Young’s memorandum.
There were 12 actions pending in federal courts throughout the country when Young filed her MDL request on Oct. 10. When the Judicial Panel on Multidistrict Litigation’s decision came down on Dec. 7, there was a total of 21 lawsuits pending in various district courts nationwide. Those lawsuits, along with any future C-Qur lawsuit filed in federal court, will now be transferred to the District of New Hampshire.
Read more about the decision to consolidate here.
C-Qur Mesh Recall
The C-Qur mesh and C-Qur Edge V-Patch were both the subject of class II recalls in 2013. The recalls were initiated by Atrium in July 2013 and classified as class II by the FDA the following month.
The meshes were recalled after it became known the products could adhere to the inner packaging liner during shipping or storage if exposed to high humidity.
More than 32,000 C-Qur meshes and 1,500 C-Qur Edge meshes were taken off the market in the US and internationally.
The recall was finally terminated in March 2016, nearly three years after it was initiated.
What is the C-Qur Hernia Mesh?
Atrium Medical’s C-Qur mesh is used to repair hernias, which can occur when an organ pushes through an opening in the muscle or tissue that contains it. Abdominal wall hernias are the most common type of hernia.
In addition to hernia repair, the C-Qur mesh is also used in chest wall reconstruction and to repair wounds caused by trauma or surgery.
The C-Qur mesh is made from a synthetic plastic-like material called polypropylene and coated with an all-natural Omega 3 gel coating. C-Qur was the first mesh to use an Omega 3 coating derived from highly purified, pharmaceutical-grade fish oil.
FDA Approves Mesh without Rigorous Testing
The U.S. Food and Drug Administration approved the C-Qur Hernia Mesh on March 31, 2006 through its 510(k) premarket process. When medical devices are approved through the 510(k) process, it means manufacturers can skip the rigorous premarket clinical tests required of other devices so long as there is a “substantially equivalent” product already on the market.
The C-Qur hernia mesh was the first mesh to use the proprietary Omega 3 coating, yet it was able to pass through the approval process using other non-Omega 3 meshes as predicates.
Atrium Medical did submit some clinical data to support its approval. The C-Qur mesh label cites a short-term animal study in lab rats, in which researchers compared the C-Qur mesh to other uncoated polypropylene meshes.
But researchers only evaluated the mesh up until the 28th day following surgery, even though the device is intended to remain inside the body indefinitely. Studies published in medical journals since the C-Qur mesh’s approval have shown the device is prone to complications after 28 days.
Types of C-Qur Hernia Mesh
Once the FDA approved the original C-Qur mesh in 2006, the company received clearance for nearly a dozen other Omega 3 coated meshes.
The following C-Qur meshes have been approved by the FDA:
- C-Qur (2006)
- C-Qur Lite V-Patch (2008)
- C-Qur Edge V-Patch (2008)
- C-Qur V-Patch (2009)
- C-Qur OVT (2010)
- C-Qur CentriFX (2011)
- C-Qur RPM (2012)
- C-Qur TacShield (2015)
- C-Qur FX (2015)
- C-Qur Mosaic (2015)
The C-Qur Hernia Mesh Lawsuit includes all types of C-Qur meshes made by Atrium.
C-Qur Hernia Mesh Complications
The numerous C-Qur Mesh Lawsuits allege the device “incites an inflammatory response that promotes bowel adhesion formation, impedes proper abdominal wall fixation, and causes additional severe complications.”
Complications associated with the C-Qur Mesh, according to the device’s label, include:
- Fluid buildup called seroma
- Hematoma, or a solid swelling of clotted blood within the tissues
- Fistula formation
- Tissue or mesh erosion
Some of these complications have resulted in revision surgeries for many patients to repair the failed mesh. This puts patients at even greater risk for additional complications.
Studies Show C-Qur Mesh Prone to Complications
Several studies published in various medical journals found the C-Qur mesh was associated with serious complications, including adhesions and infections.
One study published in the British Journal of Surgery in March 2009 found Atrium’s C-Qur mesh reduced adhesion formation in the first seven days after surgery. But by 30 days, researchers found the effect had diminished and there was a significant increase in adhesions.
A Hernia study published Oct. 18, 2016 found the C-Qur and C-Qur FX reduced adhesion formation in lab rats for the first 7 days following surgery, but those effects diminished after 21 days.
Another study published in the British Journal of Surgery in December 2012 found C-Qur was associated with significantly more mesh infections compared to other meshes in the study. Researchers said of the 16 patients implanted with the C-Qur mesh, 15 of them suffered from infection after surgery.
FDA Places Injunction against Atrium
In February 2015, the FDA announced it had placed a permanent injunction against Atrium Medical over alleged violations at its Hudson, New Hampshire facility.
The injunction came after several facility inspections conducted by the FDA between 2009 and 2013 uncovered “major” violations. The injunction was also placed on Atrium’s parent company, Getinge Group, and Getinge’s subsidiary Maquet Cardiovascular.
The FDA issued two warning letters to each of the three companies during the four-year period, citing sterilization and cleanliness violations at a Wayne, N.J. facility and marketing and production violations at a facility in Germany.
Following its inspections, the FDA issued the injunction and entered into a voluntary consent decree with Atrium, Getinge and Maquet.
In a February 2015 press release, the FDA said, “Patients must be assured that medical devices are safe, effective, and high quality. The FDA will remain vigilant in bringing companies that do not meet our regulatory requirements back to a sustainable state of compliance.”
Adhering to the terms of the injunction, Atrium halted production of its mesh products at its Hudson facility. All C-Qur meshes were affected by the FDA’s injunction, but instead of stopping production or distribution of the meshes, Atrium moved its operations to its Merrimack, New Hampshire location.
It appears the company is still under that 2015 injunction, but continues to manufacture and sell its C-Qur meshes in the U.S. The FDA even approved changes to several types of C-Qur meshes under its 510(k) program just 8 months after it took action against Atrium.
Do I qualify for a C-Qur Hernia Mesh Lawsuit?
If you’ve been injured by any of the C-Qur hernia meshes manufactured by Atrium Medical, you may be entitled to financial compensation.
To see if you qualify for a case, contact the experienced lawyers at Hood National Law Group today. We are available 24 hours a day, 7 days a week to assist you and answer any questions you may have.
Call 1-800-214-1010 to speak with a member of our legal team for a free case evaluation, or use the form on the right-hand side of your screen.
Hernia Mesh Lawsuits available in these States:
Alabama (AL), Alaska (AK), Arizona (AZ), Arkansas (AR), California (CA), Colorado (CO), Connecticut (CT), Delaware (DE), Florida (FL), Georgia (GA), Hawaii (HI), Idaho (ID), Illinois (IL), Indiana (IN), Iowa (IA), Kansas (KS), Kentucky (KY), Louisiana (LA), Maine (ME), Maryland (MD), Massachusetts (MA), Michigan (MI), Minnesota (MN), Mississippi (MS), Missouri (MO), Montana (MT), Nebraska (NE), Nevada (NV), New Hampshire (NH), New Jersey (NJ), New Mexico (NM), New York (NY), North Carolina (NC), North Dakota (ND), Ohio(OH), Oklahoma (OK), Oregon (OR), Pennsylvania (PA), Rhode Island (RI), South Carolina (SC), South Dakota (SD), Tennessee (TN), Texas (TX), Utah (UT), Vermont (VT), Virginia (VI), Washington (WA), Washington DC (DC), West Virginia (WV), Wisconsin (WI), Wyoming (WY)
Atrium C-Qur Hernia Mesh Lawsuit complications & recall page updated on August 22, 2017