Defective Ventralex Hernia Mesh Had to be Surgically Removed, Lawsuit Alleges

A new product liability lawsuit filed against medical device maker C.R. Bard alleges that problems with the company’s Ventralex hernia mesh device resulted in serious complications requiring revision surgery to remove the mesh years after it was implanted. The lawsuit was filed last month by James Keaulana and his wife in the U.S. District Court for the District of Hawaii and included allegations that the design of the hernia mesh device was defective and posed an unreasonable and dangerous risk. If you received a hernia mesh implant that you eventually had to have removed or replaced due to complications, you may be able to pursue compensation through a hernia mesh lawsuit. Consult an experienced hernia mesh injury attorney today to discuss your options for legal recourse.

What is Hernia Mesh?

Hernia mesh, also known as surgical mesh, is an implantable, screen-like medical device commonly used to surgically repair a hernia, which occurs when an organ, intestine or fatty tissue protrudes through a hole or weak spot in the surrounding muscle or connective tissue. Surgical mesh is designed to provide additional support to weakened or damaged tissue, by reinforcing muscle walls and preventing organs or tissue from squeezing through, and over the years, mesh has become the most common course of treatment for surgical hernia repair. In fact, more than one million hernia repairs are performed each year in the United States and more than 80% of those surgeries use mesh. Unfortunately, not all hernia mesh surgeries are successful and many patients who receive surgical mesh for hernia repair end up requiring additional surgeries to address problems like mesh erosion and mesh migration.

Lawsuits Over Hernia Mesh Complications

  1. R. Bard faces a growing number of lawsuits filed on behalf of patients who were implanted with the company’s hernia mesh devices and subsequently suffered serious complications requiring additional surgeries. According to allegations raised in this latest hernia mesh lawsuit, the plaintiff underwent surgery to repair an epigastric hernia in October 2010. The hernia was repaired with a Ventralex ST Hernia Patch by Davol, which is a brand of C.R. Bard. On its website, Bard describes the Ventralex patch as “A clinically proven umbilical hernia repair solution with SorbaFlex™ Memory Technology and an absorbable barrier featuring Sepra® Technology.”

In November 2018, eight years after James Keaulana’s original hernia repair surgery, he had to undergo revision surgery to have the Ventralex hernia mesh implant removed. In his lawsuit, Keaulana blames the mesh failure on the design of the Ventralex patch, which consists of two layers of synthetic polypropylene mesh stitched together with polytetrafluorethylene 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 hernia mesh 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.”

Problems with Synthetic Materials in Hernia Mesh

The synthetic materials used in many hernia mesh products have been heavily scrutinized in recent years due to growing concerns about the potential for the foreign materials to increase the risk of mesh-related complications. The majority of hernia mesh devices currently on the market are constructed from synthetic materials, which are meant to be stronger and last longer. Over the past several decades, there has been an increase in the use of polypropylene meshes and research has shown that these synthetic mesh devices are associated with a higher rate of failure. Due to a potential risk of severe complications and higher-than-expected failure rates, thousands of mesh products have been recalled since 2005, including those manufactured by Bard and Ethicon.

In his lawsuit, Keaulana claims that Bard’s failure to provide patients and the medical community with adequate warnings about the potential risk of device failure and other side effects associated with hernia mesh exposed him to an unnecessary risk that could have been avoided. The lawsuit will be consolidated with other hernia mesh claims filed against C.R. Bard in the federal court system, which have been centralized for coordinated pretrial proceedings as part of a multidistrict litigation (MDL) in the U.S. District Court for the Southern District of Ohio. The lawsuits all involve similar allegations that problems with Bard’s hernia mesh products exposed users to an increased risk of side effects, including the following:

  • Mesh erosion
  • Organ perforation
  • Mesh infection
  • Mesh migration
  • Bowel obstruction
  • Mesh shrinkage
  • Bleeding
  • Fistulas
  • Adhesion
  • Chronic pain
  • Hernia recurrence

Contact a Hernia Mesh Injury Lawyer for Help

Bard currently faces more than 3,500 product liability lawsuits involving its Ventralex, PerFix, Composix and other hernia mesh products, which plaintiffs claim were defectively designed and put them at risk for painful and debilitating complications requiring revision surgery to remove or replace the mesh. If you or someone you love has suffered a hernia mesh complication like mesh migration or erosion, or if you have required revision surgery to remove a failed mesh device, you may be entitled to financial compensation for your medical expenses, lost wages due to missed time at work, permanent disability or other defective mesh-related losses. Contact a knowledgeable product liability lawyer as soon as possible to discuss your claim and explore your possible compensation options.