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According to allegations raised in a product liability lawsuit filed C.R. Bard, problems with Ventralex hernia mesh resulted in serious complications and the need for hernia revision surgery years after the patch was implanted.
The complaint (PDF) was filed last month by James Keaulana and his wife, Eileen, in the U.S. District Court for the District of Hawaii, indicating that the design of the polypropylene mesh was defective and posed severe risks for patients.
James Keaulana underwent epigrastric hernia repair in October 2010, at which time he was implanted with a Davol Mesh Ventralex Patch. However, after the hernia repair failed, he had to undergo revision surgery in November 2018.
The lawsuit blames the problems on the materials used in the Ventralex patch design, which consists of two layers of polypropylene mesh stitched together with polytetrafluorethylene monofilament.
“Despite Defendants’ claims that this material is inert, a substantial body of scientific evidence shows that the mesh material is biologically incompatible with human tissue and promotes an immune response in a large subset of the population receiving the product,” Keaulana’s lawsuit states. “This immune response promotes degradation and contracture of the polypropylene mesh, as well as the surrounding tissue, and can contribute to the formation of severe adverse reactions to the mesh.”
Keaulana indicates that Bard failed to provide adequate warnings about those risks to patients or the medical community, joining a growing number of hernia mesh lawsuits filed against the manufacturer nationwide, each raising similar allegations of design problems associated with various products sold in recent years.
The complaint will be consolidated with other claims pending in the federal court system against Bard, which are currently centralized as part of a federal MDL (multidistrict litigation) in the Southern District of Ohio, where one judge is presiding over coordinated discovery and pretrial proceedings.
There are currently more than 3,500 product liability lawsuits pending against C.R. Bard in a federal multidistrict litigation (MDL), involving painful and debilitating complications following hernia repairs with Bard Ventralex, Bard Perfix, Bard Composix and other polypropylene products.