A woman has filed a lawsuit alleging Ethicon hernia mesh complications led to her needing surgery to have the mesh removed.

Plaintiff Joan C. says in her hernia mesh lawsuit that she received an implantation of the Ethicon Proceed Surgical Mesh as part of a hernia repair in May 2015.

In late December 2016, Joan alleges she had the hernia mesh removed. A pocket of clear fluid called a seroma had formed in and around the mesh, which had been causing her irritation and pain. A seroma is a collection of the thin, watery serous fluid found in body cavities that provides lubrication between membranes.

Joan alleges that she still suffers from severe pain that impairs her daily activities.

Ethicon Hernia Mesh Complications

According to Joan’s complaint, the Ethicon Proceed Surgical Mesh used in her hernia repair was never subject to clinical testing because it was cleared by the Food and Drug Administration’s fast track program. The FDA allows medical devices that drug companies can show are similar enough to other devices skip some of the FDA’s regulatory steps for clearance.

The Proceed surgical mesh was one of Ethicon’s multi-layered hernia mesh products. According to the hernia mesh lawsuit, Ethicon allegedly knew the following faults of the product before 2003 that could result in serious Ethicon hernia mesh complications:

• A layer of oxidized regenerated cellulose allegedly was not effective at preventing adhesion formation to the underlying layer of polypropylene, a plastic/polyester material, because the pores in the cellulose were too large.
• Formation of adhesions would increase the mesh’s overall shrinkage.
• Polypropylene “elicits a chronic, life-long inflammatory response…”
• Gamma irradiation weakens the polypropylene layer and causes it to become brittle.

The Proceed multi-layer hernia mesh purportedly is made of:

• An Oxidized Regenerated Cellulose (ORC) barrier layer
• A Polydioxanone (PDS) film layer
• A large-pore polypropylene (Prolene soft mesh) layer

Polypropylene hernia mesh devices are often sterilized with ethylene oxide, the Ethicon hernia mesh complications lawsuit explains. The oxidized regenerated cellulose layer allegedly reacts by degrading when it comes into contact with ethylene oxide.

Ethicon also allegedly sterilizes the mesh with gamma irradiation, which weakens the polypropylene layer before it even enters a patient’s body. The embrittled polypropylene purportedly increases the risks of the material to tear away from sutures designed to hold it in place within the body.

“For decades, there were concerns in the medical community about severe complications if polypropylene was placed too close to the bowel or other underlying organs, due to the formation of dense adhesions to the polypropylene,” alleges the hernia mesh lawsuit.

Joan’s hernia mesh complaint goes on to allege the multiple layers increase the potential for an intense and lingering inflammatory response that gives rise to the formation of tough adhesions.

The multiple layers also trap and retain serous fluid, increasing the risks of infection and of seroma formation. According to the Ethicon hernia mesh directions, the polypropylene met side is supposed to “placed adjacent to those tissues where tissue ingrowth is desired.”

The Ethicon Hernia Mesh Complications Lawsuit is Case No. 3:18-cv-17746 in the Superior Court of New Jersey, Law Division, Middlesex County.