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On January 2, 2018, a Mississippi man filed a Bard hernia mesh lawsuit in the Southern District of Mississippi. The plaintiff claims that after he was implanted with a Bard Ventralex mesh, he suffered from serious injuries.

Plaintiff Claims that Bard Ventralex Mesh Caused Complications

According to his complaint, the plaintiff underwent hernia repair surgery on March 18, 2014. His doctors used an eight-centimeter circular Bard mesh during the surgery.

The mesh didn’t perform as expected, causing the plaintiff to experience significant pain and other complications. On June 6, 2017, he underwent surgery to revise the allegedly defective mesh. In that surgery, the doctors used a ProLite mesh product instead. The plaintiff seeks in excess of $75,000 in damages.

Bard Ventralex Approved Through FDA’s Fast-Track Process

The Bard Ventralex mesh is a patch-like product designed to help repair abdominal hernias. It contains two layers of polypropylene mesh that is supposed to fully absorb into the body with time.

The FDA first approved the Bard Ventralex on July 16, 2002. The product, however, did not have to undergo clinical trials for that approval. It was sent through the FDA’s fast-track 510(k) program, which only requires manufacturers to show a new product is significantly similar to other products on the market.

The company claimed that the product was similar to one of their previous mesh products, the Bard Kugel. But that product was recalled in 2005, and the recall expanded in 2006 and 2007, because they found that the “memory recoil ring,” could break and lead to bowel perforations and other complications.

Studies Show Higher Rate of Problems with Bard Ventralex

Some studies have indicated problems with the Bard Ventralex mesh. In 2014, for example, researchers reported on a comparison they’d made between the Ventralex and the Cabs’Air Composite mesh made by Cousin Biotech. They looked at 83 patients who had a hernia repair, one group with the Ventralex, and one with the Cabs’Air.

Results showed that according to surgeons, placement of the Cabs’Air was easier. At 3 months after the surgery, there was less pain and discomfort in the Cabs’Air group than in the Ventralex group, and the patient satisfaction rate was also higher. Long-term follow-up in 77 of the patients showed four hernia recurrences for the Ventralex group, as well as one mesh infection, one small bowel obstruction, six cases of severe pain resulting from shrinkage, and six that required reoperations. No such complications were reported in the Cabs’Air group.

Plaintiff Brings Counts of Negligence and Design Defect

The plaintiff in this case states that the manufacturers should have known that their mesh product was incompatible with human tissue and often caused complications in patients. He brings counts of negligence, design and manufacturing defect, and breach of warranties.

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