Bard faces a ventral hernia mesh lawsuit alleging that their Ventralight product is defective and caused complications after hernia repair surgery.

Plaintiff Judy G. says she was diagnosed with a ventral hernia in May 2014. In June 2014, she says she underwent ventral hernia repair surgery and was implanted with the Bard Ventralight ST Mesh product. Complications with the mesh allegedly caused Judy to experience chronic abdominal pain, further infections, and fluid draining from the umbilicus.

Due to the complications, Judy says she underwent a removal of the hernia mesh in May 2016. The complaint says that after her surgery, she had a wound vac, which is a device that decreases air pressure around the wound to help it heal quicker. Her healing and subsequent treatments lasted through November 2017. Judy claims that the complications she suffered were due to the defective nature of the Bard mesh, an argument made in her ventral hernia repair lawsuit. 

“As a result of having the Product implanted, the Plaintiff has experienced significant mental and physical pain and suffering and mental anguish, has sustained permanent injury, has undergone medical treatment and will likely undergo further medical treatment and procedures, has suffered financial or economic loss, and/or lost income, and other damages,” the ventral hernia mesh lawsuit argues.

Judy filed her ventral hernia mesh lawsuit in an attempt to hold Bard accountable. Judy’s husband Don G. is also a plaintiff in the ventral hernia mesh lawsuit and brings a claim for loss of consortium.

Hernia mesh products are used in the repair of a hernia and the treatment of hernia organ prolapse. Not all mesh products are created equal and can be associated with complications. In April 2016, the U.S. Food and Drug Administration (FDA) published an article which identified “pain, infection, hernia recurrence, adhesion, and bowel obstruction” as the most common adverse events associated with hernia mesh implants. Other potential complications include mesh migration and mesh shrinkage.

Bard has several hernia mesh repair products which were allegedly cleared for use by the FDA through the 510(k) approval process. This approval process requires manufacturers to show that their products are substantially equivalent to an approved product already on the market. However, this allows manufacturers to skip clinical testing.

According to the ventral hernia mesh lawsuit, Bard has portrayed their Ventralight mesh as a safe product. However, the product is allegedly associated with a variety of complications, and some patients say it is not fit to be used during hernia repair surgery. Judy argues that clinical testing would have shown that the Ventralight mesh is defective and not a safe option for hernia mesh repair.

“The scientific evidence Defendant knew or should have known of demonstrates that the mesh is incompatible with human tissue and often causes a negative immune response in patients implanted with the Product, including Plaintiff,” the ventral hernia mesh lawsuit claims.

Judy and Don bring a variety of claims including negligence, design defect, manufacturing defect, failure to warn, breach of warranty, violation of consumer protection laws, and loss of consortium. The ventral hernia mesh lawsuit seeks damages in excess of $75,000 as well as interest, court costs, and attorneys’ fees.

The Ventral Hernia Mesh Lawsuit is Case No. 2:18-cv-16254-WHW-CLW in the U.S. District Court for the District of New Jersey.