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Problems with a fish oil gel coating allegedly caused an Ohio woman to suffer complications from an Atrium C-Qur hernia patch, resulting in a recurring hernia and severe adhesive disease, which led to the need for surgical removal of the mesh, according to a product liability lawsuit filed against the manufacturer.
The complaint (PDF) was filed by Willie Calloway in the U.S. District Court for the Western District of Pennsylvania, indicating that an 8 x 8 cm Atrium C-Qur mesh implanted during hernia repair surgery was defectively designed and poses an unreasonable risk of severe adverse reactions.
Calloway received the patch during surgery in November 2010, for repair of an umbilical hernia. However, in February 2015, she indicates she had to be admitted to a hospital for repair of a recurrent incarcerated hernia, after she developed a painful lump in the area of the original hernia repair.
During the surgery, doctors found numerous and large adhesions between the mesh patch and her abdominal walls and small bowels, as well as several tears on the small bowels. As a result of the complications, the lawsuit indicates that two feet of her small bowels had to be removed.
Atrium C-Qur is a polyproylene hernia repair mesh coated with an Omega 3 Fatty Acid Fish oil (O3FA), which is not used in any other hernia repair products sold in the United States. While the manufacturer has indicated that this coating is designed to prevent or minimize adhesion and inflammation, Calloway indicates it did not.
According to allegations raised in the lawsuit, the Atrium C-Qur mesh fish oil coating actually prevented the adequate incorporation of the mesh into the body, and created a risk of inflammatory and chronic foreign body response that caused damage to surrounding tissue and improper healing.
“When the Omega 3 coating is disrupted and/or degrades, the “naked” polypropylene mesh is exposed to the adjoining tissue and viscera, and can become adhered to organs, and cause incarceration of organs, and fistula formation,” the lawsuit states. “Due to serious problems with sterilization and quality control in the Atrium manufacturing facilities, the Omega 3 coating was not uniformly applied to the C-QUR Mesh devices. The Omega 3 coating applied to the mesh caused or contributed to the propensity of the C-QUR Mesh to roll, curl and deform upon insertion into the body, intensifying the inflammatory and foreign body response to the mesh, and exacerbating the lack of adequate incorporation and improper healing response, and potential for adhesion.”
The case joins a growing number of Atrium C-Qur mesh lawsuits filed in courts throughout the U.S., each raising similar claims that Atrium knew or should have known about the risk of problems associated with the hernia patch and large number of adverse events reported. However, the manufacturer has not issued any warnings or any official Atrium C-Qur recalls, instead choosing to withhold information from consumers and quietly remove certain products from the market.
Given the similar questions of fact and law raised in dozens of cases filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) decided to consolidate all lawsuits filed against Atrium last month, centralizing claims before U.S. District Judge Landya McCafferty in the District of New Hampshire, for coordinated pretrial proceedings.
As additional Atrium C-Qur cases are filed in U.S. District Courts nationwide, they will be transferred to Judge McCafferty for coordinated handling during discovery and a series of early “bellwether” trials, which are designed to gauge how juries are likely to respond to certain evidence and testimony that is likely to be repeated throughout the litigation. However, if Atrium CQur hernia mesh settlements or another resolution is not reached following the MDL proceedings, each individual case may be remanded back to the U.S. District Court where it was originally filed for a separate trial date.