Hernia mesh manufacturer C.R. Bard and subsidiary Davol, Inc., are facing a growing number of hernia mesh lawsuits for products that were brought to market through the FDA’s 510(k) program. Plaintiffs in Louisiana and Mississippi are suing Bard and Davol for selling hernia mesh repair products that are incompatible with human tissue; they allege that because of the fast track provided by FDA’s 510(k) approval, human trials were not required.
Numerous hernia mesh devices were brought to market under U.S. Food & Drug Administration’s 510(k) program which is a fast track clearance program that allows products to go to market that are similar to pre-existing market devices. Current claims allege that hernia mesh manufacturers failed to produce a safe product, used unsafe and inferior materials in their products, and that materials are not compatible with human tissue. It is this incompatibility with human tissue that results in corrective surgeries. Complications from these products include extreme pain, abscesses, infection, migration, obstructions, and swelling that often multiple corrective surgeries.
Recently, Randy Roberts and Reginald Sanders sued C.R. Bard, Inc. and its Davol, Inc. subsidiary in Louisiana. Both plaintiffs allege hernia mesh complications, including severe abdominal pain and infections, requiring corrective surgeries. In January, Patrick Dove filed suit in the Southern District of Mississippi after experiencing similar complications from the Bard Ventralex patch device. The complaint alleges that that the material used in the hernia mesh was ultimately incompatible with human tissue and the defendants knew or should have known of this incompatibility.