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Atrium C-QUR Hernia Mesh Lawsuit

Atrium C-QUR Hernia Mesh Lawsuit

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 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.

Overview

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
  • Inflammation
  • Hernia recurrence
  • Infections or abscesses
  • Allergic reactions
  • Body rejects mesh
  • Adhesions (excessive scar-tissue growth)
  • Organ damage
  • Foreign body reaction
  • Mesh erosion, migration, or failure
  • Surgery

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.

C-QUR Mesh Class Action

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, Atrium asked judges to centralize the cases in a “mass-tort” or Multi-District Litigation (MDL) in New Hampshire.

Recall Issued for C-CUR Edge

In 2013, Atrium recalled C-QUR Edge Mesh because the fish oil coating could peel off and stick inside the package when exposed to heat and moisture. This suggests a similar risk in the human body. Atrium issued a warning, but did not pull it off the market.

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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