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According to allegations raised in a product liability lawsuit filed against C.R. Bard and it’s Davol, Inc. subsidiary, a Ventralex hernia patch disintegrated and migrated years after it was placed in a North Carolina woman, resulting in an infection and other complications before it was removed.
In a complaint (PDF) filed last week in the U.S. District Court for the Southern District of Ohio, Detra Forde-Stephenson indicates that the manufacturers sold a defective hernia repair product, which created an unreasonable risk of health problems.
Forde-Stephenson indicates that a Bard Ventralex patch was used during a hernia repair surgery in September 2007. However, nearly ten years later she had to undergo additional surgery to have the hernia mesh removed from her body in June 2017. At that time, it was found that the hernia patch had disintegrated, migrated out of position, contracted, buckled and caused an infection, as well as a foreign body reaction. In addition, the revision surgery caused Forde-Stephenson to suffer other post-operative complications, requiring further surgery in July 2017.
The Bard Ventralex features a bi-layer construction of a self-expanding patch, which contains two layers of polypropylene that are stitched with polytetrafluorethylene (PTFE) monofilament to an expanded polytetrafluoroethylene (ePTFE) sheet. The mesh also features a recoil ring using SorbaFlex Memory Technology, known as the PET ring, which is an absorbable polydioxanone (PDO) monofilament.
The lawsuit indicates that Bard knew there was a problem with the ring and quietly changed the design instead of adequately warning the medical community or patients.
In 2013, Defendants conducted a silent recall by changing the design of the Ventralex Mesh to no longer include the defective PET ring,” the lawsuit states. “Defendants never issued a recall on the Ventralex Mesh, nor did they notify the public or health care professional of its defective nature.”
The case joins a growing number of similar Bard hernia patch lawsuits filed in recent months, each raising allegations that the manufacturers should be liable for complications that may arise years after a hernia repair.
Forde-Stephenson’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 lawyers continue to review and file cases in the coming months and years, it is ultimately expected that close to 10,000 complaints may eventually be filed against various different companies by individuals who received polypropylene hernia mesh products.