Every year, millions of people are diagnosed with hernia, a condition typically treated with the implantation of mesh to support and strengthen the herniated area and prevent further damage. Atrium Medical C-QUR mesh is often used to repair hernia, but some patients say the device can cause serious problems and complications. Hundreds of patients have taken action against the mesh maker seeking justice. If you have suffered a hernia mesh injury, speak to a hernia mesh implant attorney at our office today to learn more about the problems with hernia mesh devices and whether you are eligible to seek compensation for your injuries.
C-QUR Hernia Mesh Controversy
In 2006, Atrium Medical Corp got the approval it needed to get a new type of hernia mesh on the market. Now to get this approval, Atrium applied through the FDA’s 510(k) process, an approval program that allows medical devices to get to the market quicker than products that go through the traditional approval process.
Traditionally, the FDA approves a device for sale on the U.S. market after at least two large clinical studies are conducted for safety and efficacy. But under the 510(k) process, device makers do not have to conduct two large studies, they only have to conduct one, and it does not have to involve a large number of participants, nor does it have to be a lengthy study, even though medical devices are often implanted in the body permanently or for a long duration.
To have a device approved through the 510(k) process, device makers only need to prove their product is substantially similar to a device already on the market. The FDA does not conduct a look-back to see if the previously approved device has been recalled or removed from the market, it doesn’t check to see if patients who receive the device are suffering harm, and it doesn’t review the MAUDE database for medical device reports or review adverse events reported by the medical community and their patients. The FDA simply makes sure the device is indeed, similar to one already on the market.
But this is where things get murky, as the C-QUR hernia mesh was approved because it was similar to another device, but it is marketed as being the only device of its kind. The C-QUR mesh is coated with Omega-3 fatty acids that are supposed to work as a barrier that prevents the scarring the can lead to adhesions. However, adverse event reports show the mesh can cause an inflammatory response in the body that can cause patients the very problem the mesh was advertising as being able to prevent- adhesions.
And, in 2012, the FDA issued warnings about patients suffering infections with the mesh, questionable mesh sterilization processes during manufacturing, and contamination of the mesh products with foreign materials. Then, in 2013, a Class 2 recall was issued after it was reported that the Omega-3 Fatty Acid coating of the C-QUR Edge mesh was sticking to its packaging.
Patients are fed up with the complications, the injuries, and the problems and hundreds have filed lawsuits asking the court to hold the manufacturer accountable for its C-QUR mesh products and the injuries patients suffered. More than 400 lawsuits have been centralized to New Hampshire District Court, and the first bellwether case is scheduled to be heard by U.S. District Judge Landya McCafferty in early 2020.