ernia mesh is a surgical product that is used during hernia repair surgery. These products are implanted into the organ wall over the hernia to stabilize tissue. Hernia mesh in now used in roughly 90% of the more than one million hernia repair surgeries performed every year in the US today.
When hernia mesh patches were first approved more than five decades ago, it was believed that they would reduce complications and increase the success rate of hernia surgeries. As its popularity among the medical community gained momentum in the 1990s and early 2000s, reports of serious complications began to pile up. More and more medical device companies began churning out new mesh products via the FDA’s fast track 510(k) process, which requires only minimal additional testing as the approval relies on the rigors of the original hernia mesh product Premarket Approval (PMA).
Some of the most common issues associated with hernia mesh products are that they tend to migrate from their original placement, shrink, or harden into a ball or mass. In some instances, the body may reject the mesh or have an adverse reaction due to the ‘coating’ the mesh is encased with. Common side effects include infection, intestinal obstruction, permanent nerve damage causing chronic pain, and a hernia reoccurrence. In many instances, multiple surgeries are required to correct the issues caused by this ‘stabilizing’ product.
Litigation involving hernia mesh products goes back to the early 2000s, with C.R. Bard device division, DaVol, paying out more than $184 million in 2011 to resolve some 2,700 lawsuits regarding issues that arose from their Composix Kugel mesh. One might expect that other manufacturers would apply greater safeguards to their products in the coming decades, but alas this did not happen.
Current Status Of Litigation
There are numerous consolidated actions in various phases of litigation against a litany of manufacturers. Most notably are MDL #2753, the Atrium C Qur consolidated proceedings in the US District Court of New Hampshire, MDL #2782, for the Ethicon Physiomesh litigation in the North District of Georgia, and MDL #2846 for the C.R. Bard suite of hernia mesh products in the Southern District of Ohio. Multiple bellwether trials are moving forward in 2021, laying the groundwork to resolve tens of thousands of cases filed across the country. While the first Atrium C-Qur bellwether was resolved prior to the beginning of the trial, the first Bard hernia mesh bellwether resulted in a defense verdict. The second Bard bellwether is set to begin in January 2022.
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