North Carolina Woman Claims Bard Ventralex Hernia Mesh Failed, Causing Infection

A North Carolina woman recently filed a new Bard hernia mesh lawsuit in the U.S. District Court for the Southern District of Ohio. The plaintiff claims that after she was implanted with the defendants’ hernia mesh product, she suffered significant and permanent injuries and significant pain and suffering.

Plaintiff Undergoes Revision Surgery to Remove Failed Ventralex Hernia Mesh

According to her complaint, the plaintiff went through a hernia repair surgery on September 27, 2007. At the time, the surgeon implanted a Bard Ventralex Patch to help facilitate the repair. On June 12, 2017, however, the patient had to undergo a second surgery to remove the hernia mesh, as it had failed. During the revision surgery, doctors discovered that the mesh had disintegrated, migrated, contracted, and buckled, causing an intense foreign body reaction and infection.

The plaintiff suffered from post-operative complications and had to go through additional surgical procedures on July 23, 2017.

Design of Mesh Makes it Prone to Shrinkage and Infection

The Ventralex hernia mesh is a patch-like device made from polypropylene and ePTFE (polytetrafluoroethylene). The plaintiff asserts that the polypropylene side was intended to promote the products’ incorporation into bodily tissues, while the ePTFE side was designed to prevent the formation of adhesions between the mesh and other organs.

Instead, the plaintiff states that the ePTFE side “results in the product being highly prone to infection,” while the polypropylene side “results in the product being extremely difficult to remove once the Ventralex Mesh becomes infected.” She adds that both sides are prone to excessive shrinkage.

The FDA originally approved the Ventralex mesh in 2002, based on the FDA’s fast-track 510(k) approval program. The program allowed the manufacturer to bypass clinical studies to ensure the safety of the device by simply showing that the mesh was similar to others already on the market.

The product also contains a permanent memory recoil ring called a PET ring that the plaintiff says is prone to breakage. In 2013, Bard changed the design so the product no longer contained the ring, but they never recalled the previous mesh.

Studies Raise Doubts on Bard Mesh Safety

Several studies have linked hernia mesh with dangerous side effects and difficult removal. In August 2017, doctors published a case report of a patient who after being implanted with the Ventralight ST mesh, had to go through multiple additional procedures to remove it because it had migrated and eroded into the bladder, causing fistulas to form between the bladder and abdominal wall.

In a 2015 study, researchers followed about 6,000 patients who went through umbilical hernia surgery between 2004 and 2010. Those who received the Ventralex implant were more likely to have a recurrence of a hernia than those who went through traditional repair without mesh.

The plaintiff brings counts of manufacturing and design defect, failure to warn, negligence, breach of warranties, violation of consumer protection laws, gross negligence, negligent infliction of emotional distress, negligent misrepresentation, and fraudulent concealment. She seeks both compensatory and punitive damages.