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Hernia Mesh victims, it’s time to speak out.

Photo Credit - Drug Guardians

Weldon Stanford

- Author, Drug Guardians

The C-Qur hernia mesh lawsuit is against Atrium Medical Corporation for failure to warn about their defective hernia mesh. The individual hernia mesh lawsuits are not Atriums only problem, the FDA conducted several investigations into the company and eventually sued Atrium in 2015. However the FDA has not issued a class 1 recall on Atriums C-Qur hernia Mesh. In July 2016 Atrium experienced a sudden increase in the number of lawsuits filed in federal court regarding the C-Qur hernia mesh and reports of C-Qur hernia mesh related injuries continue to come in despite the Atrium C-Qur hernia mesh still being implanted around the country.
The Atrium C-Qur (pronounced Secure), was first approved by the FDA in March of 2006, under the FDA 510(k) approval program. The 510(k) approval program allows companies to skip rigorous pre-market research and studies, rather being allowed to be marketed as a previously approved mesh approved in the 1990’s; Products approved under 510(k) are highly susceptible to lawsuits, as opposed to products that receive more in depth pre-market testing. This was despite Atrium’s C-Qur hernia mesh being the first ever mesh to utilize an Omega 3 fatty acid gel coating.

The C-Qur hernia mesh is utilized for more than just ventral and inguinal hernias, and has been used for chest wall reconstruction, as well as traumatic and surgical wounds. It’s ‘claim to fame’ is it’s all natural Omega 3 Fatty Acid gel coating. This Omega 3 fatty acid coating is highly purified pharmaceutical grade fish oil consisting of a unique blend of triglycerides, O3FA, and many other substances coat the mesh itself. The alleged issue with the Atrium C-Qur hernia mesh, leading to Atriums lawsuits, is the O3FA coating, causing allergic reactions and potentially life threatening complications as a result of lack of sterilization.
The original Atrium C-Qur, with Omega 3 Fatty Acids, is not the only hernia mesh produced by Atrium. With this product being originally manufactured for open and laparoscopic hernia repair, other more specific meshes have been created for more defined functions. Despite lawsuits pending for almost all of Atrium’s C-Qur range, the only Atrium hernia mesh to be recalled is the C-Qur Edge.
On October 11, 2016, C-Qur hernia mesh lawyers filed a motion seeking to create a federal docket for all C-Qur hernia mesh cases filed nationwide, with the district of New Hampshire being the appropriate forum for consolidation. At the time of the filing there was 13 C-Qur lawsuits pending in federal courts, 6 of which were filed in the District of New Hampshire, with the first lawsuit being filed there as well, under Judge Landya Boyer McCafferty. Judge Landya has therefore been recommended to continue to preside over the entire litigation.

The MDL hearing for the C-Qur hernia mesh took place on December 1st, 2016 with Judge McCafferty decision expected any day now.

 

 

Sources:
www.atriummed.com/en/biosurgery/cqur.asp
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2639496

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