Hernia is a common condition that affects millions of men, women, and children every year. Unfortunately, some of the mesh products used to repair hernias can cause serious complications and adverse events. C-QUR mesh, made by Atrium Medical, is a commonly used hernia repair device that is at the center of hundreds of injury lawsuits. If you suffered serious complications after being implanted with the C-QUR device, contact us today. You may be eligible to seek significant financial compensation for your injuries through a hernia mesh lawsuit. We can help.
The Controversy Behind C-QUR Mesh
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Before a medical device is sold on the market, it must get approval from the FDA. Most devices are approved using the traditional pre-market approval process, but many are approved through a program known as the 510(k)-approval process. This is a controversial approval process that allows medical devices to be sold on the market far sooner than devices going through traditional approval.
Atrium Medical received FDA approval for C-QUR in 2006 through the 510(k) process. Typically, a device is approved for sale on the market after multiple large clinical studies, but the 510(k) process is essentially a loophole that allows the manufacturer to get approval without these studies. In fact, to have a device approved through this program, the manufacturer proves that the device is substantially similar to one that is already on the market. Unfortunately, the government watchdog agency does not look back at the history of the device to see if it has been recalled, it does not review its adverse event reports, and no review panel investigates patient injury reports. The agency simply ensures the devices are substantially similar.
But this is where things get tricky because the C-QUR hernia mesh was approved through the 510(k) process because it is substantially similar to a device already on the market. However, the C-QUR mesh is marketed and advertised as the only device of its kind. You see, the C-QUR mesh has an Omega-3 Fatty Acid coating that is supposed to act as an adhesion barrier and prevent scarring. But reports filed with the FDA’s adverse event database list severe inflammatory responses to the mesh that led to adhesions, the very complication the device was touted as preventing.
It Gets Worse
Other problems with the mesh were reported that eventually led to an FDA warning about an increased number of patients developing infections after implantation, foreign material contamination, and questionable manufacturing sterilization processes. Then, a year later in 2013, the FDA issued a Class 2 recall for the C-QUR Edge mesh after it was determined that the Omega-3 coating was sticking to the packaging.
Lawsuits have been filed against Atrium Medical in courts across the country on behalf of patients who are demanding the maker be held accountable for the complications and injuries the C-QUR mesh caused. Hundreds of federally-filed lawsuits were centralized to U.S. District Court in New Hampshire under District Judge Landya McCafferty. According to court documents, the first bellwether trial in the multidistrict litigation is scheduled for early 2020.