Ethicon Prolene Hernia Mesh Created Unreasonable Risks, Lawsuit Claims

An Illinois woman indicates that design defects with the Ethicon Prolene Hernia System caused her to suffer severe pain and nerve entrapment, indicating that there are unreasonable risks with the hernia mesh sold by Johnson & Johnson and it’s Ethicon Inc. subsidiary. 

The complaint (PDF) was filed by Karen Hager on January 24, in the Superior Court of New Jersey for Middlesex County, joining a growing number of similar claims filed over risks associated with various different Ethicon hernia mesh products distributed in recent years.

Hager indicates that an Ethicon Prolene Hernia System was used during a hernia repair in March 2014. However, as a result of problems with the prosthetic mesh, Hager indicates that she has suffered severe and chronic pain, ultimately requiring revision surgery to remove the mesh in January 2017. At that time, it was discovered that the Ethicon Prolene mesh had entrapped her inguinal nerve.

The lawsuit indicates Johnson & Johnson and Ethicon sold a product that poses an unreasonable risk of injury, including pain, dense adhesion formation, organ complications, mesh shrinkage, hernia recurrence, seroma and fistula formation and infections, all of which made the product defective and unsafe for its intended use.

“The mechanism of failure in Plaintiff’s device was a mechanism of failure that Defendants had marketed and/or warranted would not occur because of the Prolene Hernia System’s design and composition,” the lawsuit states. “The implanted device that Defendants marketed and warranted (i.e., the Prolene Hernia System) would not have failed but for the defective design and composition thereof.”

The complaint raises allegations that are similar to those presented in other hernia mesh lawsuits filed over Ethicon products, which feature a multi-layer design that has been linked to thousands of reports involving painful complications.

Hagar also indicates that Ethicon and Johnson & Johnson failed to perform sufficient clinical trials or studies before marketing the multi-layered hernia mesh product line was introduced, which includes the Prolene Hernia System, as well as the recalled Ethicon Physiomesh product.

In addition to other Ethicon mesh lawsuits, there are also a number of Bard hernia mesh lawsuits and Atrium C-Qur lawsuits pending nationwide over complications associated with those other polypropylene designs sold by other companies.

As individuals who have experienced complications following a hernia repair continue to investigate and review potential cases with lawyers nationwide, it is expected that tens of thousands of complaints may be brought against manufacturers in the coming months.