Atrium C-QUR Hernia Mesh is coated in fish oil (Omega-3). It is marketed as a way to prevent side effects, but more than a dozen lawsuits have been filed by people who developed severe pain, inflammation, adhesions, or needed surgery to treat complications.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting hernia mesh induced injury cases in all 50 states. If you or somebody you know has been diagnosed with a complication or needed surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
UPDATE: Lawsuit Blames Fish Oil Coating on Reaction
January 9, 2017 — A lawsuit (PDF) has been filed by a man from New Hampshire who blames the “biologically incompatible” fish oil coating on hernia mesh for causing major complications. Lawyers say Atrium “recklessly disregarded human life by lying to physicians about the possible causes of the allergic reactions, resulting in significantly more severe injuries.” Click here to read more.
Atrium Medical Corporation sells a variety of C-QUR Hernia Mesh (pronounced “Secure”). The products are coated in Omega-3 fatty acid (O3FA), more commonly known as fish oil, including:
- C-Qur Mesh
- C-Qur Edge
- C-Qur Mosaic
- C-Qur TacShield
- C-Qur V-Patch
- C-Qur Centrifix
- C-Qur FX Mesh
- C-Qur Lite
C-QUR Mesh Approved Without Clinical Trials
C-QUR Mesh was approved 2005 with a 510(k) application, which means the FDA allowed it on the market without clinical trials because it was “equivalent” to other types of hernia mesh on the market. However, it was actually the first — and only — fish oil hernia mesh.
Anti-Inflammatory “Adhesion Barrier”
Atrium told the FDA that C-QUR Mesh was just like other hernia mesh, but it was certainly advertised as unique. The fish oil coating was marketed as an anti-inflammatory “adhesion barrier.” Adhesions are scar-tissues that grow during the healing process and stick organs together. They can cause many complications that require surgery.
Does Fish Oil Mesh Work?
Fish oil pills have shown anti-inflammatory effects in a few studies. However, without clinical trials, there is no way to know if hernia mesh covered in fish oil effectively prevents adhesions without causing more serious side effects.
Case Report of Adhesions and Inflammation
C-QUR is advertised to prevent adhesions, but in one case report, a 61 year-old woman developed “dense adhesive disease around the mesh” due to an inflammatory foreign body reaction to the fish oil.
Side Effects of C-QUR Mesh
- Chronic pain
- Hernia recurrence
- Abdominal abscesses
- Allergic reactions
- Body rejects mesh
- Adhesions (excessive scar-tissue growth)
- Organ damage
- Foreign body reaction
- Mesh erosion, migration, or failure
Hernia Mesh Lawsuits
One lawsuit (PDF) was filed by a woman from Georgia who was implanted with C-QUR in 2008. She developed major infections and other complications over the next few years. Surgeons who removed the mesh said it was “bunched up in layers” or “folded up” in her body.
In another lawsuit (PDF) filed in December 2016, a woman from Arkansas was seriously injured when her body rejected a TacShield Hernia Mesh — likely due to its fish oil coating, doctors said — and it “balled up” inside her body, causing severe pain, digestive problems, infections, scar-tissue, and chronic inflammation. She required multiple corrective surgeries.
C-QUR Mesh Class Action vs. MDL
Atrium is facing more than a dozen C-QUR hernia mesh injury lawsuits. They are individual lawsuits rather than a class action. In November 2016, lawyers asked judges to centralize the cases in a “mass-tort.” In December, the judges agreed to create Multi-District Litigation (MDL No. 2753), transferring 21 lawsuits into the U.S. District Court for New Hampshire under Judge Landya B. McCafferty — In Re: Atrium Medical Corp. C-QUR Mesh Products Liability Litigation.
Recall Issued for C-CUR Mesh
In 2013, Atrium issued Class II recalls for over 100,000 units of C-QUR Mesh — including the V-Patch Mesh, Edge Mesh, and TacShield Mesh — because the fish oil coating could peel off and stick inside the package when exposed to heat and moisture. Atrium issued a warning, but did not pull it off the market. Lawsuits have been filed by people who say they were injured when the coating peeled off inside their body.
Studies of C-QUR Mesh Infections
In 2013, a clinical trial of the C-QUR V-Patch had to be stopped early due to high rates of infections. The preliminary results were never published. In another study involving 8 types of hernia mesh and 144 rats, 15 out of 16 rats implanted with C-QUR developed infections — more than all the other types of mesh combined.
FDA Issues Warning for Poor Manufacturing
In 2012, Atrium was cited by the FDA for ignoring reports of infections and product contamination — specifically, 35 confirmed cases of hair being found inside supposedly “sterile” products. In 2015, Atrium was forced to stop making C-QUR Mesh until the violations were corrected.
Do I have a Hernia Mesh Lawsuit?
The Schmidt Firm, PLLC is currently accepting Atrium C-QUR Hernia Mesh induced injury cases in all 50 states. If you or somebody you know has been injured, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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