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More than a dozen years after undergoing a hernia repair, a Texas woman indicates that she had to undergo additional surgery to remove Bard Ventralex from his body, after the hernia mesh failed due to design problems.
In a product liability complaint (PDF) filed in the U.S. District Court for the District of New Jersey on September 27, Ida DeLeon indicates that C.R. Bard and it’s Davol, Inc. subsidiary failed to warn or notify doctors, regulatory agencies and consumers and the risk of severe and life-threatening health risks that may result from Bard Ventralex mesh.
DeLeon indicates that the monofilament polypropylene patch was used during a ventral hernia repair in June 2003. However, after experience complications caused by a Bard Ventralex failure, she had to undergo additional surgery to remove the mesh in January 2016.
Bard Ventralex features a bilayer construction of a self-expanding patch, which contains two layers of polypropylene that are stiched with polytetrafluorethylene (PTFE) monofilament to an expanded polytetrafluoroethylene (ePTFE) sheet. The mesh also features a recoil ring using SorbaFlex Memory Technology, which is an absorbable polydioxanone (PDO) 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,” the 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.”
As a result of the hernia mesh failure, DeLeon indicates that she has been left with chronic pain and permanent disfigurement.
The case joins a growing number of similar Bard mesh lawsuits filed in recent months, each raising allegations that the manufacturers should be liable for complications that may arise years after a hernia repair.
DeLeon’s complaint will be consolidated with other complaints pending in the federal court system, which have been centralized as part of a federal Bard hernia mesh MDL in the Southern District of Ohio, where one judge is presiding over coordinated discovery and pretrial proceedings.
As lawyer continue to review and file cases in the coming months and years, it is ultimately expected that close to 10,000 hernia mesh lawsuits may eventually be filed against various different companies by individuals who received polypropylene products.