Umbilical Hernia Mesh Lawsuit Alleges Serious Injuries

An umbilical hernia mesh lawsuit filed by a Florida woman against two medical device makers alleges painful and debilitating injuries due to a defective medical device.

In addition, the plaintiff in the umbilical hernia mesh lawsuit claims emotional distress, economic losses, and overall diminished quality of life. She holds the defendants liable for manufacturing and selling a product they knew, or should have known, was defective, as well as failure to warn patients and physicians.

The Product

The cause of action in the present umbilical hernia mesh lawsuit is known as the Ventralex Hernia Patch. It was jointly developed by the defendants, C.R. Bard and its subsidiary, Davol, Inc., which have been targeted in previous lawsuits over mesh products. The device was developed in response to concerns by medical researchers over the danger of inflammation of underlying organs resulting from the close proximity of plastic-based mesh.

According to the Bard website, this product is “a self-expanding polypropylene and ePTFE patch that allows for an intraabdominal, tension-free repair.” The use of these plastics was intended to avoid problems such as adhesion and inflammation, which have been issues with other hernia mesh patches.

The Ventralex was first approved in 2002 through a controversial FDA process known as 510(k) Pre-Market Notification. This allows a medical device manufacturer to bypass clinical testing requirements when they can demonstrate that the new device is substantially equivalent to a product already on the market.

The Umbilical Hernia Mesh Lawsuit Cause of Action

Plaintiff Jennifer T. says she underwent laparoscopic-assisted surgery in July 2014 in order to repair an umbilical hernia, using the Ventralex. She says the product was represented to her as safe and effective. Instead, she alleges she developed serious complications, necessitating revision surgery for the removal of the patch a little over four months later.

Jennifer claims the multi-layer construction of the Ventralex makes infection more likely. The plastic materials used in its manufacture are known to cause inflammation and are prone to shrinkage, she says. Furthermore, she claims the sterilization method used for the device has been shown to be inadequate; infections can reportedly develop months or years after the device is implanted.

The umbilical hernia mesh lawsuit alleges that the Ventralex Mesh is “cytotoxic, immunogenic, and not biocompatible, which causes or contributes to…delayed wound healing, inflammation…rejection, infection, and other complications.”

The Defendants

C.R. Bard has been a named defendant in more than one umbilical hernia mesh lawsuit. Previously, the company was sued over its Kugel Hernia Patch, which ironically, was the “predicate device” that was the basis of its 510(k) application for the Ventralex. Prior to this, Bard paid out over $200 million to settle approximately 3,000 lawsuits over its vaginal meshes, which had many of the same complications and defects. Davol is a Bard subsidiary, involved in research and development.

Do You Have Grounds for an Umbilical Hernia Mesh Lawsuit?

Sadly, Bard is only one of several medical device companies that have been accused of marketing defective hernia mesh. If you have been implanted with one of these devices and have experienced complications and health problems as a result, you may be eligible to file an umbilical hernia mesh lawsuit in order to recover damages for pain and suffering, medical expenses, lost wages and more.

The current Umbilical Hernia Mesh Lawsuit is Case No. 2:18-cv-01531-EAS-KAJ, United States District Court for the Southern District of Ohio.