A Pennsylvania woman has filed a lawsuit against a medical device manufacturer, alleging hernia surgery mesh failure lead to serious health consequences.

Plaintiff Patricia I. claims that a hernia mesh manufactured and marketed by defendant Ethicon caused a number of injuries that have left her permanently disabled, negatively impacting her quality of life. She has demanded a trial before a jury.

Case Background

Patricia says she underwent surgery in January 2016 for the treatment of an abdominal hernia. The product was manufactured and sold by Ethicon, Inc., a subsidiary of global health care conglomerate Johnson & Johnson. According to her complaint, her “surgeon, medical staff and other healthcare providers met or exceeded the standard of care applicable to the surgery.”

The product that was used in Patricia’s surgery was Ethicon’s Proceed Ventral Patch, one of a number of hernia meshes in the company’s product line. The lawsuit alleges that the hernia surgery mesh failure became apparent less than a year later when Patricia’s physician diagnosed her with a recurrent hernia. Revision surgery was recommended, according to Patricia.

Hernia Surgery Mesh Failure Injuries Remain

Despite revision surgery, Patricia says the damage had been done. She says she has continued to suffer recurring hernias in addition to nausea, vomiting and diarrhea caused by intestinal blockage. Her injuries have allegedly led to weight loss and stress and anxiety related problems that have prevented her from engaging in many ordinary day-to-day activities.

Patricia alleges that had it not been for manufacturing defects resulting in hernia surgery mesh failure, she would not be suffering from the effects of these injuries today.

The Cause of Action

Ethicon advertises the Proceed Ventral Patch as a “sterile, self-expanding, partially absorbable, flexible laminate mesh device designed for the repair of hernias” that offers “[s]trong repair with potential for low recurrence.”

The device is made from polypropylene, an inert substance that is known to be incompatible with human tissues, alleges the lawsuit.

In order to address this problem, Ethicon applied a layer of oxidized regenerated cellulose (ORC), a material derived from plants used in gauze and surgical sponges — a material that is very inexpensive to produce. The manufacturing process employs radiation in order to sterilize the device. However, polypropylene weakens when exposed to radiation, causing it to degrade over time. The lawsuit alleges that this degradation rate has been known since 1996. This degradation is allegedly the cause cause of hernia surgery mesh failure as the device comes apart inside the body.

What Did the Defendants Know?

The Proceed Ventral Patch was given FDA approval in May 2006, through the increasingly infamous 510(k) Premarket Notification process. This essentially means that, because Ethicon claimed the mesh was “substantially equivalent” to an older device, it was able to dispense with clinical studies and rigorous (and expensive) testing normally required of new products.

Problems became apparent almost immediately, alleges the lawsuit. Adverse event reports of hernia surgery mesh failure started coming in less than a year after the Proceed Ventral Patch was approved. Since its introduction, the Proceed Ventral Patch has been the subject of no less than three recalls.

Patricia’s Hernia Surgery Mesh Failure Lawsuit is Case No. 3:18-cv-17143-FLW-DEA, Superior Court of New Jersey, Law Division, Middlesex County.