Johnson & Johnson and its subsidiary Ethicon Inc. face a new Proceed hernia mesh lawsuit filed by a Louisiana woman alleging she suffered severe injuries after undergoing hernia mesh repair surgery.

Plaintiff Shawanna S.  filed the lawsuit on Dec 11, 2017, in Louisiana federal court.

According to the Proceed hernia mesh lawsuit, Shawanna says she was implanted with the Proceed hernia mesh, a product that utilizes a light-weight polypropylene, in December 2015.

As a result of the Proceed hernia mesh implant, she suffered from injuries including pain, hernia mesh recurrence, and having to undergo another surgery, the Proceed hernia mesh lawsuit states.

The Proceed hernia mesh lawsuit is filed on multiple counts including breach of express warranty, negligence, redhibition, breach of warranty of fitness for ordinary use, and breach of implied warranty.

Shawanna demands a trial by jury.

Proceed Hernia Mesh Basics

According to the Proceed hernia mesh lawsuit, the Proceed hernia mesh utilizes a light-weight polypropylene. Allegations against the companies state that they knew that polypropylene was unsuitable for use in the human body but chose to continue with its use regardless.

Allegations contend that to reduce the adverse effects caused by the polypropylene, the company decided to add a protective layer to the Proceed hernia mesh.

However, the Proceed hernia mesh with the added layer was allegedly deemed completely useless. Following implantation of the added protective layer, the layer is said to completely wear away, leaving behind the polypropylene.

The added protective layer of the Proceed hernia mesh is an added coating composed of Oxidized Regenerated Cellulose (ORC). Cellulose, a polysaccharide organic compound, is well known as a component in the cell wall of plants.

The added protective layer is made of an oxidized cellulose, which, along with the polypropylene layer, is hit with radiation through a sterilization method. Allegedly, once the polypropylene is sterilized and exposed to radiation, it weakens and begins to degrade over time through a chain reaction.

Studies have examined the effects of sterilization methods on polypropylene such as one published in 2003 titled Sterilization Effects on Polypropylene: Technology and Polymer Type Effects.

The study discovered that radiation results in a degradation effect which causes severe embrittlement and reduced melt viscosity. The radiation also causes the material to turn yellow and these effects last for a long period of time after the sterilization method.

The Proceed hernia mesh was recalled by Ethicon in 2011 and 2014, but the recall was never issued in the United States. Instead, the company voluntarily pulled the Proceed hernia mesh off the market in May 2016 in what is termed a “market withdrawal.”

Complications reported with the Proceed hernia mesh include hernia recurrence, abdominal pain, wound issues, and the need for removal surgery.

Several hernia mesh products have been linked to severe complications and adverse effects, including Ethicon’s Proceed and Physiomesh hernia mesh, Covidien’s Parietex, Atrium’s C-Qur, and C.R. Bard Inc.’s 3DMax, Perfix, and Sepramesh.

The Proceed Hernia Mesh Lawsuit is Case No. 5:17-cv-01604-RGJ-MLH, in the U.S. District Court for the Western District of Louisiana, Shreveport Division.