A Missouri patient has filed a ventral hernia mesh lawsuit against Davol and its parent company, Bard, claiming that the ePTFE Bard Mesh is defective and can cause dangerous complications.

Plaintiffs Clarence W. and Sharon W. claim that Clarence underwent surgery on or around Aug. 8, 2014, to remove an infected ventral hernia mesh. According to the couple, Clarence’s surgeon noted that the hernia mesh in question was entirely detached from were it had been implanted, and was floating in bodily fluid and tissue.

The couple says that the device was ineffective as a hernia mesh, was defective in its design, and caused Clarence injury because of its defects.

The ventral hernia mesh lawsuit alleges that Clarence suffered physical injury as a result of the ePTFE Bard Mesh, and continues to experience medical complications and physical injury because of the hernia mesh. Allegedly, he will likely have to undergo additional surgeries to repair the damage from the ePTFE Bard Mesh. Additionally, Clarence says he suffered emotional injury from the trauma of his injuries and has suffered financial injury because of the medical costs associated with dealing with the negative effects of the mesh.

Clarence and Sharon aim to hold Davol and its parent company C.R. Bard accountable for Clarence’s injury. The couple claims that Davol and Bard knew or should have known that the device was defective and continued to market and sell it nonetheless, knowingly endangering patients.

Hernia meshes are products used to repair a hernia or tear in a muscle wall. Hernia meshes are artificial patches that provide the structure where a patient’s body lacks it. The ventral hernia mesh lawsuit states that the ePTFE Bard Mesh is composed of two layers — an ePTFE sheet, and a polypropylene mesh.

According to the couple, the polypropylene layer in the ePTFE Bard Mesh is designed to promote scarring into the abdominal wall while the ePTFE side prevents adhesion between the polypropylene and underlying organs.

Allegedly, the ePTFE makes the product very prone to infection, and the polypropylene makes the device very hard to remove once it becomes infected. The couple argues Davol and Bard should have known that for decades in the medical community, there have been concerns that an infection could occur if a foreign object like a mesh was placed too close to the bowels or other organs, “due to inflammation in the presence of sensitive organs and the formation of dense adhesions to the device.”

Additionally, the ventral hernia mesh lawsuit alleges that the ePFTE Bard mesh was not subjected to rigorous enough testing before being released onto the market. Clarence and Sharon say that the device was approved via a “fast-track” approval process for medical devices that are “substantially equivalent” to a device already on the market.

Allegedly, this process allows a device to be released onto the market with less than the usual amount of pre-market testing. However, the couple claims that due to a loophole in the law, the only “substantially equivalent” devices to the ePFTE Bard mesh were produced before 1976.

The National Institutes for Health noted the problems with this loophole, saying that devices approved for sale before 1976 “did not include any evaluation of the safety and effectiveness of individual medical devices … Thus it is common for devices to be cleared…by being found substantially equivalent to devices that were never individually evaluated for safety and effectiveness, either through the original device classification program or through the [fast track approval] process.”

The ventral hernia mesh lawsuit alleges that Davol and Bard did not comply with FDA application and reporting requirements by releasing a device onto the market that had not been subject to sufficient testing.

The Ventral Hernia Mesh Lawsuit is Case No. 1:18-cv-002001, in the U.S. District Court for the Eastern District of Missouri.