Patients report hernia mesh problems with Johnson & Johnson products, saying that the design of the mesh is defective.

In her hernia mesh lawsuit filed recently, plaintiff Sarah W. says that she had an Ethicon Proceed Ventral Patch hernia mesh made by Johnson & Johnson and Ethicon implanted in her body on Aug. 5, 2015. She says that the device caused her injury, and required her to undergo two additional surgeries to repair the damage done by the mesh.

The Renaissance School of Medicine at Stony Brook University notes that hernia mesh devices are a common medical device used to provide structural report to a muscle or organ that is experiencing an improper weakness or opening. 

According to Sarah, she experienced pain and suffering, physical injury, and finical injury from the device. She claims that she continues to suffer from the injury she suffered because of the device, saying that she “continues to experience severe pain, which has impaired her activities of daily living and relationships.”

She aims to hold Johnson & Johnson, the company that owns the device, and Ethicon, a company owned by Johnson & Johnson that produces the mesh liable for her injury. She claims that the companies knew or should have known that the device was defective and dangerous, but marketed it as safe and effective.

Sarah says that had she known that the device could cause injury, she would not have agreed to have the Proceed Ventral Patch and its related components device implanted in her body.

She says that on Oct. 5, 2016, she underwent another surgery to repair a recurrent hernia without a mesh, and then on July 14, 2017, underwent a repair of a recurrent hernia and had another mesh placed, replacing the mesh used in her 2015 surgery.

According to the hernia mesh problems lawsuit, the device caused her injury because its design was defective. She says this type of defect has been documented since around the 1990s, arguing that Johnson & Johnson and Ethicon knew or should have known that the design could be harmful, but produced and sold the devices nonetheless.

Allegedly, the device was not subjected to sufficient testing before it was sent onto the market. She says that it was approved via a “fast track” approval process that allowed devices that are “substantially equivalent” to other devices already on the market to be released onto the market without premarket testing.

However, the hernia mesh problems lawsuit argues that the Proceed Ventral Mesh is not substantially equivalent to other devices. Allegedly, the Proceed Ventral Mesh was not marketed as a resorbable adhesion barrier when its maker sought FDA approval, but then after it was approved, marketed it as such.

A resorbable adhesion barrier is used when applying a medical device to the body to prevent the device itself from adhering to the body in a harmful way. When the barrier adheres, this presents the device from doing so, and in the case of a resorbable adhesion barrier, the barrier absorbs into the body. 

To support the claim that the device was indeed marketed as a resorbable adhesion barrier, Sarah notes that the companies describe the device as having one side that “provides a bioresorbable layer that physically separates the polypropylene mesh from underlying tissue and organ surfaces during the wound-healing period to minimize tissue attachment to the mesh.”

Sarah argues the device possessed an inadequate design for hernia repair, and was not sufficiently tested before it was released onto the market.

The Hernia Mesh Problems Lawsuit is Case No. 3:19-cv-00303-FLW-DEA, in the U.S. District Court for the Superior Court of New Jersey Law Division, Middlesex County.