Davol and parent company Bard face a lawsuit following hernia mesh failure symptoms.

Plaintiff Rebecca E. accuses Davol and Bard of manufacturing and distributing a faulty product which caused physical harm and hernia mesh failure symptoms post-procedure.

Rebecca alleges she underwent repair of a hernia in October 2013. Her doctor used the ST Bard Mesh, manufactured and distributed by the defendants. In April 2014, less than a year later, Rebecca says she underwent a second surgery to remove the failed hernia mesh.

During the procedure, Rebecca’s doctor found significant adhesions in her abdomen as a result of the mesh that he had to fix. She was then implanted with a new mesh. However, Rebecca claims she continues to experience complication related to the ST Bard Mesh and will likely need further surgeries to repair the damage.

Hernia Mesh Complications

Hernia mesh has been in use for over 50 years. Despite it being the tried and true method for hernia repair, not all hernia mesh products operate at the same standards. Many individuals experience severe hernia mesh failure symptoms following the use of certain hernia mesh products.

Hernia mesh failure symptoms may include pain, swelling, adhesions, obstructions, mesh migration, bacterial infections, and hernia recurrence. Hernia mesh failure often requires additional surgeries to repair new hernias, remove faulty hernia mesh, and re-implant new hernia mesh.

The ST Bard Mesh in Rebecca’s case was cleared by the FDA under the 510(k) Premarket Notification program. This clearance process does not require full clinical testing; device manufacturers are simply required to notify the FDA at least 90 days before they market a device claimed to be substantially equivalent to a device the FDA approved for sale before 1976.

By clearing the ST Bard Mesh through this 510(k) program, Davol and Bard allegedly avoided clinical testing of their product. Rebecca argues that they should have put their products through the proper clinical testing and that, had they done the testing, they would know that their mesh product has a high risk for complication.

Rebecca argues that “poor quality control and general non-compliance resulted in the non-conformance of the ST Bard Mesh implanted.” She alleges that the use of substandard polypropylene and raw materials used to make the ST coating on the meshes resulted in her severe hernia mesh failure symptoms.

In her lawsuit, Rebecca claims that Davol and Bard were aware of the consequences of implantation of the ST Bard Mesh, including the risk of failure and injury, but distributed the product anyway to maximize their profits.

“Even though Defendants have other hernia repair mesh devices that do not present the same risks as the ST Bard Mesh, Defendants developed, designed and sold ST Bard Mesh, and continue to do so, because the ST Bard Mesh has a significantly higher profit margin than other hernia repair products,” alleges the lawsuit.

Rebecca accuses Davol and Bard of strict liability, negligence, breach of warranty, violation of consumer protection laws, concealment, and misrepresentation. She seeks trial by jury, damages, medical costs, attorney’s fees, and court costs.

The Hernia Mesh Failure Lawsuit is Case No. 4:18-cv-00116-HFS in the U.S. District Court for the Western District of Missouri.