A woman filed a Ventralex mesh lawsuit in New Jersey U.S. District Court against C.R. Bard, Inc., alleging she suffered severe adverse side effects and complications due to its implantation.

Plaintiff Lisa W. files the Ventralex mesh lawsuit demanding a trial by jury. The lawsuit was filed on Oct. 3, 2018.

On or about Sept. 9, 2014, according to the Ventralex mesh lawsuit, Lisa underwent repair of an incisional hernia at Texas Health Presbyterian Hospital. It was then that she was implanted with a Ventralex ST Mesh. However, the product was soon explanted due to serious adverse side effects and complications she suffered.

Lisa says that she relied on the manufacturer’s representation of the product as being a safe and effective product.

Her Ventralex mesh lawsuit was filed on multiple counts including manufacturing defect, design defect, failure to warn, negligence, breach of express warranty, Violation of Consumer Protection Laws, gross negligence, negligent infliction of emotional distress, fraudulent concealment, negligent misrepresentation, and punitive damages.

Overview: Ventralex Mesh Lawsuit

There have been several lawsuits filed against C.R. Bard over severe adverse side effects and complications stemming from patients being implanted by the Ventralex hernia mesh. A hernia occurs when fatty tissue, an organ, or intestine squeezes through a hole or weak area through connective tissue or muscle.

Common types of hernia include femoral, inguinal, ventral, umbilical, hiatal, and incisional. Additionally, a hernia may be caused by anything that increases abdominal pressure. Causes may include things like lifting heavy objects, constipation, diarrhea, obesity, and persistent coughing/sneezing. Other issues that can contribute to hernias include overexertion, smoking, and poor nutrition.

Each year, there are one million hernia repair surgeries performed.

Hernia Mesh

A hernia mesh is a device that provides extra support for the damaged and weakened tissue. Physicians also commonly use a surgical mesh device to strengthen the hernia repair and decrease recurrence potential.

The issue, however, is that the product is made up of polypropylene; and despite risks associated with polypropylene, Bard continues to manufacture the product.

Bard produces many hernia mesh products. Its Ventralex mesh product was approved by the U.S. Food and Drug Administration (FDA) on July 16, 2002. It was approved through the FDA’s 510(k) approval program that allowed Bard to skip pre-market clinical studies and research to ensure safety and efficacy of the Ventralex mesh.

Ventralex mesh was granted approval based on its similarity to the company’s Kugel mesh. However, Kugel was recalled in March 2006.

Severe adverse side effects and complications with the mesh have been blamed on  an alleged biological incompatibility of the mesh materials. Adverse side effects linked to the Ventralex mesh include bowel obstruction, high potential for breakage, adhesion, oxidation, migration, malfunction of the memory recoil ring, wadding up, separation, tearing, and splitting.

According to the FDA, many complications like these have been reported. The most common complications include infection, pain, adhesion, recurrence, obstruction, and perforation.

The Ventralex Mesh Lawsuit is Case No. 2:18-cv-14589-CCC-SCM, in the U.S. District Court for the District of New Jersey.