Even though hernia repair is a common procedure that millions undergo each year, some of the products used to make those repairs have been blamed for injuries and adverse events that should never happen. At the heart of the controversy surrounding these products are hundreds of victims who have suffered pain and infections, perforation of organs and tissue, adhesions, and unplanned surgical procedures. If you were implanted with a hernia mesh that caused these types of complications, you might be entitled to a surgical hernia mesh lawsuit settlement for compensation. Contact us today to learn more.
Physiomesh and the FDA 510(k) Process
Physiomesh, a mesh manufactured by Ethicon, a subsidiary of Johnson & Johnson, is named in thousands of lawsuits filed across the country. It is one of several meshes that were approved under an FDA program that allows medical devices to get to the market sooner. Traditionally, device makers have to conduct at least two large clinical trials on the safety and efficacy of the device and report the results to the FDA prior to getting approval. But the 510(k) process allows device makers to bypass these lengthy studies and simply show the FDA that their device is very similar to one that has already been approved. While the manufacturer does generally have to do one safety study prior to approval, the study does not have to involve many participants, and the length of the study can be quite short.
When a device maker like Ethicon puts a product through the 510(k) process, it shows that their product, in this case Physiomesh, is substantially similar to a mesh product that is already on the market. But part of the controversy surrounding the approval process is that the FDA does not look back to see if the approved device has been recalled or pulled from the market because it is defective. The FDA does not search its adverse event reporting system to see the history of adverse event reports, complications and side effects of the device. The FDA simply checks to ensure the devices are substantially similar.
Physiomesh was approved through the FDA 510(k) process in 2010 and in 2014 a second version of the mesh was approved. But all the while, the FDA was receiving adverse event reports concerning the high rates of infection patients were suffering and about the high number of patients who were forced to undergo additional surgeries to have the device removed from their bodies and repair the internal damage it may have caused. The device was recalled from the market in 2016 because of these adverse events.
More than a thousand victims have filed lawsuits against Ethicon, and over 1,200 of these cases have been centralized to U.S. District Court in Georgia to be heard under one judge in multi-district litigation. Recently, U.S. District Judge Richard W. Story ordered that mesh products removed from patients should be preserved for evidence.
Any patient who receives the Physiomesh hernia repair mesh and suffers serious side effects such as the erosion and failure of the mesh, chronic pain, infection, adhesions, organ perforation and revision surgeries, may be entitled to seek significant compensation for their injuries and the losses they experienced due to those injuries. Contact us today to learn more.