Bard Ventralex Hernia Mesh “Silent Recall” Issued Due to Complications, Lawsuit Claims

According to allegations raised in a product liability lawsuit filed over complications from Bard Ventralex hernia mesh, a “silent recall” was issued by the manufacturer to address design defects, while avoiding bad publicity. 

The complaint (PDF) was filed by Jennifer S. Tedder in the U.S. District Court for the Southern District of Ohio on November 27, indicating that C.R. Bard, Inc. and it’s Davol Inc. subsidiary never issued an official Ventralex mesh recall, or notified the public and medical community about design changes that removed a defective memory recoil ring.

Tedder indicates that a Bard Ventralex patch was used during a hernia repair surgery she underwent in July 2014. However, just a few months later, in December 2014, she had the mesh removed because it had failed.

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 featured a recoil ring using SorbaFlex Memory Technology, known as the “PET ring”, which is an absorbable polydioxanone (PDO) monofilament.

According to allegations raised in the lawsuit, Bard knew there were problems with the PET ring, and decided to quietly change the design of the hernia mesh, rather than adequately informing doctors and patients about the risk.

Tedder claims that these actions amounted to a “silent” hernia mesh recall in 2013. However, the lawsuit alleges that the manufacturer knew or should have known about the dangerous design before the Ventralex mesh was ever placed on the market.

“For decades, there were concerns in the medical community about severe complications if a foreign object, such as a mesh, was placed too close to the bowel or other underlying organs, due to inflammation in the presence of sensitive organs and the formation of dense adhesions to the device,” Tedder’s lawsuit notes. “Defendants marketed their Ventralex Mesh to be placed next to the bowel.”

The case joins a growing number of similar hernia mesh lawsuits filed against Bard and other manufacturers, over design problems associated with a number of different devices sold in recent years.

Tedder’s complaint will be consolidated with other lawsuits filed against Bard in the federal court system, which have been centralized as part of a federal Bard hernia mesh MDL (multidistrict litigation), which is centralized in the Southern District of Ohio, where one judge is presiding over coordinated discovery and pretrial proceedings.

Similar centralized proceedings have already been established for Ethicon hernia mesh lawsuits and Atrium C-Qur mesh lawsuits, each of which already involve several hundred claims.

As hernia mesh lawyers continue to review and file cases for individuals who have experienced complications, 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.