Ethicon Physiomesh Not Safe For Use in Hernia Repair, Lawsuit Alleges

A product liability lawsuit filed over complications linked to Ethicon Physiomesh indicates that the recalled hernia repair patch poses unreasonable health risks, causing a California man to develop chronic seroma and require multiple additional surgeries. 

John Guerra filed the complaint (PDF) in the U.S. District Court for the District of New Jersey on June 14, naming Johnson & Johnson and its Ethicon subsidiary as the defendants.

According to the lawsuit, Guerra underwent a procedure to repair an incisional hernia, which included the implanting of a 5 cm by 8 cm Physiomesh hernia patch. However, in January 2014, he underwent surgery again due to complications caused by the mesh.

The complaint indicates that Guerra suffered chronic seroma and had to undergo excision of the seroma cavity repeatedly. This reduced, but did not destroy the seroma.

Ethicon Physiomesh features a unique design, with two layers of polyglecaprone-25, also known as Monocryl, and two underlying layers of polydioxanone film. The coating was applied to the polypropylene mesh to minimize adhesion and inflammation and help the mesh incorporate into the body. However, the hernia mesh design has been associated with numerous reports of problems.

“The multi-layer coating of Defendants’ Physiomesh is cytotoxic, immunogenic, and not biocompatible, which causes or contributes to complications such as delayed wound healing, inflammation, foreign body response, rejection, infection, and other complications,” Guerra indicates in his lawsuit. “Defendants knew or should have known of the cytotoxic and immunogenic properties of the multi-layer coating of the Physiomesh prior to introducing it into the stream of commerce.”

As a result of the design defects, Guerra indicates that Ethicon Physiomesh was not safe for its intended purpose as a hernia repair mesh.

In June 2016, Ethicon recalled Physiomesh products from the market worldwide, due to a high rate of problems and revisions among individuals who had the patch implanted, since the manufacturer was unable to identify or correct the underlying cause of the complications.

Although the action was classified as a “market withdrawal” in the United States, Ethicon asked hospitals to return all unused implants and indicated that it does not intend to return the product to the market.

The case filed by Guerra joins a growing number of Ethicon Physiomesh lawsuits filed in recent months by individuals who suffered painful and debilitating problems following hernia repair surgery.

Given the similar questions of fact and law presented in cases pending throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) decided to establish coordinated pretrial proceedings in the federal court system earlier this week, which will result in the transfer of Guerra’s case, as well as future complaints filed nationwide, to U.S. District Judge Richard Story in the Northern District of Georgia to reduce duplicative discovery, avoid contradictory pretrial rulings and to serve the convenience of the parties, witnesses and the courts.

As hernia mesh lawyers continuing to review and file additional lawsuits in the coming weeks and months, it is expected that several thousand complaints will be included in the MDL proceedings.