Bard Hernia Mesh Lawsuit Alleges Companies Failed to Warn of Serious Device Complications

A Florida man is suing C.R. Bard and subsidiary Davol Inc. after allegedly suffering “serious and potentially life-threatening medical conditions” he claims was the result of a defective Ventralex ST Mesh device implanted to repair a hernia.

In his Bard mesh hernia lawsuit, plaintiff Fabricio B. says that he developed serious complications shortly after a March 2017  laproscopic procedure to repair an umbilical hernia using the ST Bard Mesh device.

The mesh product contains a polydioxanone (PDO) inner ring that is supposed to aid in the healing process and help the body adjust to the product, according to the suit. The PDO ring breaks down over a period of up to eight months after implantation, spurring muscle inflammation around the hernia, the lawsuit further alleges.

The Ventralex ST Bard Mesh was “defectively manufactured,” according to Fabricio’s complaint, and failed to perform as intended and “had to be surgically removed necessitating further invasive surgery to repair the very issue that the product was intended to repair.”

Overview of Hernia Mesh Complications

A hernia occurs when an organ, intestine or fatty tissue manages to permeate a hole or weak spot in the surrounding muscle or connective tissue, typically in the abdominal wall. Each year more than a million hernia repairs are performed in the United States, according to Dr. Andrew T. Bates of New York’s Stony Brook Comprehensive Hernia Center.

There are a variety of surgical approaches to repair a hernia. For decades, doctors have used surgical mesh to provide an additional support net to help the muscle recover.

However, numerous patients have reportedly suffered serious complications related to hernia mesh products. According to the U.S. Food and Drug Administration (FDA), the most common complications include severe pain, infection, hernia recurrence, adhesion, bowel obstruction, mesh migration and mesh contraction.

Sometimes the only way to treat these symptoms is for the patient to undergo revision surgery.

The ST coating hernia mesh product has been associated with serious adverse reactions including mesh migration, excess adhesion formation, mesh erosion, and rejection.

The lawsuit further points out that the ST coating inhibits tissue ingrowth and causes tissue reaction, which increases the likelihood of infection and excessive adhesion formation.

According to the Bard hernia mesh lawsuit, Fabrico and his doctor were reportedly unaware of the ST Bard Mesh product’s defective nature and relied on the manufacturer’s marketing materials and product information, neither of which gave the plaintiff or his doctor reason to believe there was a risk for serious device complications.

This Hernia Mesh Lawsuit is Case No. 6:19-cv-00770-GAP-GJK, in the U.S. District Court of Florida, Orlando Division.