We have been getting a lot of calls from Atrium C-Qur hernia mesh victims. These poor people have a lot of questions and concerns and we try to lay some of those out for you here.
The C-Qur hernia mesh products are a line of polypropylene surgical implants manufactured by Atrium Medical Corp. The C-Qur hernia mesh products were one of several types of implant devices used in hernia repair surgery between 2006 and 2015. Hernia repair is one of the most frequently performed surgical procedures in the U.S. each year.
What are Hernia Mesh & Patch Devices?
A hernia is where tissue or organs in the abdominal area push out through a tear or defect in the abdominal muscle wall. Mesh and patch devices, such as the C-Qur products, are implanted during hernia surgery to strengthen and reinforce the muscle wall. Once implanted in the body, tissue will grow around the mesh. This means the devices must be inert or biocompatible to avoid rejection by the body. Like all surgical implants, they also need to be sterile. Absorbable mesh devices are made from animal tissue which is absorbed into the body after being implanted. Permanent mesh implants, such as C-Qur, are made from inert plastic materials covered with a biocompatible coating. The key feature of the C-Qur devices was their proprietary coating, which was made from derivatives of omega-3 fatty acid (O3FA) (commonly known as “fish oil”).
List of All C-Qur Hernia Mesh Products Manufactured by Atrium
Atrium’s C-Qur product line included several types of hernia mesh implants, all of which contained polypropylene mesh with the O3FA coating. Below is a list of all the Atrium C-Qur devices and the date in which they were approved for sale by the FDA.
Device Name Approval Date Used For
C-Qur Mesh March 2006 Open and Lap hernia repairs
C-Qur Lite V-Patch April 2008 Small hernia repairs
C-Qur Edge April 2008 Hernia repair; chest reconstruction; surgical wound
C-Qur V-Patch June 2009 Small hernia repairs
C-Qur OVT Mesh January 2010 Medium to large open ventral hernias
The C-Qur Mesh and the C-Cur V-Patch were the most widely used C-Qur products.
Problems with C-Qur and Other Hernia Mesh Products
Absorbable mesh devices have been around for a while with no safety concerns or reports of adverse events. The permanent mesh devices, like C-Qur and Johnson & Johnson’s Physiomesh, have been plagued by safety concerns and complaints.
The problems with Atrium’s C-Qur devices were primarily related to the design of the O3FA coating on the mesh and problems with the company’s manufacturing procedures. Soon after the C-Qur devices went on the market, reports on patients having severe allergic reactions to the O3FA coating came out. There were also reports of the O3FA becoming detached from the mesh after being implanted, resulting in an immune response and degradation of the mesh.
Besides adverse event reports from doctors, Atrium was having serious problems with the manufacturing and packing of the C-Qur products. In 2012 the FDA issued a warning letter to Atrium regarding sterilization and packaging issued with the C-Qur devices. The letter came in response to many complaints of infections and the tendency of the O3FA coating. There were even many reports of C-Qur devices with human hair found in the mesh. Atrium ignored the FDA warnings and continued to manufacture and sell the C-Qur and other devices. Complaints continued to mount and in 2015 the FDA got an injunction and forced Atrium halt the production of C-Qur devices.
Following the FDA recalls and an injunction, a stream of lawsuits starting coming in against Atrium based on injuries caused by the C-Qur mesh and patch products. In December 2016 the lawsuits in Federal Courts were consolidated into a Multidistrict Litigation (MDL) in the U.S. District Court for New Hampshire — In Re: Atrium Medical Corp. C-QUR Mesh Products Liability Litigation MDL No. 2753. The lawsuits contend that the C-Qur products were fundamentally unsafe and were put on the market without adequate testing. The C-Qur lawsuits assert several types of product liability claims against Atrium including: (a) defective design; (b) defective manufacture; (c) negligent failure to warn; and (d) consumer protection violations.
As of February 2019, there have been over 335 lawsuits filed in this litigation. Filing a lawsuit in these cases is particularly easy. You just file a short form complaint and reference the larger MDL lawsuit, which is over 50 pages long.
The design defect claims are focused mainly on the issues with the fish oil coating on the C-Qur products. The O3FA coating had a tendency to degrade quickly and would frequently separate from the plastic mesh after being implanted. In some plaintiffs, the O3FA coating caused life-threatening allergic reactions. The manufacturing defect claims relating to the various issues Atrium had with sterilization at its manufacturing plant which ultimately led to the injunction in 2015.
In the MDL, attorneys for both sides outlined their scientific arguments at the “science day” on 10/27/17. Copies of the Science Day PowerPoint presentations for the plaintiffs and for Atrium provide a good preview of what the contested issues will be in the case. Atrium’s defense team presented very little in the way of recent studies or research showing the safety of the O3FA coating. Instead, their primary defense appears to be that the adverse events experienced by the plaintiffs resulted from normal surgical complications or medical errors and not problems with the C-Qur products.
The first round of cases in the MDL are set for trial in October 2018. These have been pushed back to November 2019. The results in these initial cases will probably dictate the direction of the MDL going forward. The results of the initial “bellwether” cases will probably be used by both sides as a reference point for global settlement negotiations. The C-Qur MDL is comparatively small, with only the results of the first group of cases are used.