A man has filed a hernia mesh lawsuit against Johnson & Johnson and its subsidiary, Ethicon, Inc., a medical device company, alleging that they falsely misrepresented and inaccurately labeled the safety and effectiveness of its Physiomesh hernia mesh product.

The man, plaintiff Daniel R., an Arizona resident, says he had the hernia mesh implanted in June 2011.

An abdominal hernia occurs when intestines bulge through a weakened area in the abdominal wall. The purpose of the hernia mesh is for use in surgical hernia repair.

Using a hernia mesh instead of stitches when repairing abdominal hernias is thought to reduce the chances for recurrence. It has also been argued to allegedly have the best long-term outcomes in most situations.

Using a hernia mesh allows a patient to possess normal movement after hernia repair. The mesh allows the tension brought about by the repair to be distributed across the wall of the abdomen.

However, after having the hernia mesh implanted, Daniel says he had to undergo a surgical intervention after having an infected prosthetic hernia mesh implanted into his abdominal wall, the hernia mesh lawsuit alleges.

According to the hernia mesh lawsuit, the plaintiff had some or all the hernia mesh removed, but he was advised that he would need additional hernia repair surgery. The plaintiff alleges that he suffers and will continue to suffer from pain and complications.

The infected prosthetic hernia mesh was allegedly due to an actual compatibility between the mesh and human tissue.

The mesh is made of polypropylene and is moreover coated with a monocryl (polyglecaprone 25) layer on each side of the mesh. There is also an undyed polydioxanone film that provides the adherence between the film and mesh.

Due to the polypropylene, coating, and film, the hernia mesh lawsuit alleges that the hernia mesh is “comprised of inelastic properties, and clinical scientific data suggests that inelasticity created the biological incompatibility with human tissue.” According to the hernia mesh lawsuit, “the multi-layer coating of the product is cytotoxic, immunogenic, and not biocompatible.”

Some of the severe adverse effects reported in association with an implantation of a hernia mesh include: deformation of mesh, adhesions to internal organs, tissue damage and/or death, and excessive and chronic inflammation.

According to the hernia mesh lawsuit, the plaintiff alleges that the defendants allegedly knew of the aforementioned adverse effects of the hernia mesh product all along.

The hernia mesh lawsuit cites that the defendants had withdrawn the product from the global market in May 2016 and that data from “two large independent hernia registries in Europe” reported that hernia recurrence was significantly higher in patients having had implanted a polypropylene hernia mesh than other sets of meshes.

According to Daniel’s hernia mesh lawsuit, scientific studies have found that “the inelastic mesh may break down in its structure and allow the hernia to recur.” Moreover, although the layering and coating of the mesh was allegedly promoted by the defendants to prevent inflammation and adhesion, the lawsuit alleges that the multi-layering coating, “prevented adequate incorporation of the mesh into the body and caused or contributed to an intense inflammatory and chronic foreign body response and complications therefrom.”

The known risks of the product were not adequately reported and represented to either the implanting physician or plaintiff, the hernia mesh lawsuit contends.

This Hernia Mesh Lawsuit is Case No. 2:17-cv-01374, in the U.S. District Court for the District of Arizona, Maricopa Division.