Davol Inc. and C.R. Bard, Inc face a recent Ventralex hernia mesh lawsuit by a man alleging that he suffered severe complications after being implanted with device and undergoing hernia mesh surgery.

Plaintiff Charles V. files the Ventralex hernia mesh lawsuit in Florida federal court. The lawsuit was filed on May 14, 2018.

According to the Ventralex hernia mesh lawsuit, Charles was implanted with a Ventralax hernia mesh patch. However, following the implantation, the patch allegedly “malfunctioned” and “did not perform as safely as an ordinary consumer/patient would expect.” The lawsuit claims the mesh was “defectively designed.”

The “Ventralex Hernia Mesh Patch is made of materials which are biologically incompatible with human tissue and react negatively and sometimes dangerously with a large number of those on whom it is used,” the lawsuit states.

The Ventralex hernia mesh lawsuit was filed on multiple counts including negligence, design defect, manufacturing defect, failure to warn, breach of express warranty, and breach of implied warranty.

Charles demands a trial by jury.

Overview: Ventralex Hernia Mesh

According to the U.S. Food and Drug Administration (FDA), a hernia results when connective tissue or muscle tissue pushes through an organ, which can be caused by a variety of different conditions or activities such as the lifting of heavy objects; diarrhea; obesity; constipation; and coughing/sneezing excessively. The most common type of hernia occurs at the abdominal wall, which is caused by increased pressure on the abdomen.

Types of hernias that occur include: at the abdominal/ventral wall; at the inner groin known as an inguinal hernia; at an incision made in the abdomen known as an incisional hernia; at the naval called an umbilical hernia; and inside the abdomen known as a hiatal hernia.

The issue Charles reported with the Ventralex hernia mesh is that it may cause serious and severe adverse effects and complications due to biological incompatibility. Some of the reported adverse effects include “high potential for breakage; adhesion; bowel obstruction; malfunction of the memory recoil ring; migration; oxidation; folding over; crumpling; wadding up; hardening; separation; tearing; and splitting.”

The reason for the severe adverse effects and complications is in the composition of the Ventralex hernia mesh which has a polypropylene coating made of Omega-3 oil. Although its purpose has been said to help prevent the mesh from attaching to the body’s tissues, this is not always the case. Instead, Charles claims it causes severe adverse effects due to its allegedly defective nature.

According to the Ventralex hernia mesh suit, the plaintiff alleges that the manufacturers of the device should have known that the hernia mesh was “unreasonably harmful.” The lawsuit purports that scientific evidence shows that the manufacturers should have known that the hernia mesh coating is “incompatible with human tissue and often causes a negative immune response in patients implanted with the Mesh.”

Other hernia mesh products that have similarly caused severe adverse effects and complications have included Ethicon’s Proceed and Physiomesh hernia mesh, Covidien’s Parietex, Atrium’s C-Qur, and C.R. Bard Inc.’s 3DMax, Perfix, and Sepramesh.

The Ventralex Hernia Mesh Lawsuit is Case No. 6:18-cv-00745-RBD-TBS, in the U.S. District Court for the Middle District of Florida, Orlando Division.