A new plaintiff has come forward with her spouse to file a lawsuit after exhibiting signs of hernia mesh failure almost immediately after surgery.

Plaintiff Robin M., together with her husband, Alton M., have registered a legal claim against Johnson & Johnson and Ethicon Inc. for their role in designing, manufacturing, distributing, and selling the hernia mesh product known as Proceed.

The couple are citizens of Natchitoches Parish, La. and are seeking reparations from the defendants through the U.S. District Court for the Western District of Louisiana. The action was initiated on Jan. 14, 2019.

The Complainant’s Experience

According to the lawsuit, Robin signed herself in to Natchitoches Regional Medical Center for repair of her hernia and underwent surgery approximately one year ago on Jan. 12, 2018.

Within 24 hours, Robin allegedly exhibited signs of hernia mesh failure and injury which required that the Proceed hernia mesh product be removed. The explantation of this device occurred on Jan. 13, 2018, the couple says.

What is Proceed Hernia Mesh?

According to Medline, Proceed surgical mesh by Ethicon is comprised of a nonabsorbable polypropylene mesh encapsulated by a polydioxanone polymer. The polypropylene mesh is covered on one side with oxidized regenerated cellulose (ORC) fabric.

This fabric is made to be placed inward toward the viscera of the body as it is bioabsorbable and theoretically provides a barrier of protection from the polypropylene which faces outward.

On Jan. 14, 2011, the U.S. Food and Drug Administration (FDA) issued a recall of Proceed surgical mesh that affected 87 products in global circulation. The states reason on the recall notice was because of a potential for delamination of the mesh, but it was only noted to affect one lot.

According to this lawsuit, the defendants expose the mesh—including the polypropylene–to radiation as part of its manufacturing process. The plaintiffs claim through their counsel that this “sterilization process” degrades the polypropylene and polymers significantly.

They note that the FDA has received numerous complaints about this degradation or delamination as previously noted.

Robin also claims that polypropylene is toxic to the human body and is often treated by the human immune system as a foreign body. Foreign body responses to the material can cause signs of hernia mesh failure like the complainant experienced.

Additionally, signs of hernia mesh failure from the Proceed product can involve high fever and other signs of infection. The multi-layers of the product allegedly provide a surface for bacteria to accumulate and multiply which can contribute to an extreme sepsis complication.

Robyn and Alton are suing the defendants based upon their willingness to present and promote an allegedly defective mesh product as safe for use. They are bringing additional causes of action against the companies for failing to warn, negligence, and for breach of express warranty and warranty for fitness of use.

They are asking for reasonable compensation through the court for physical pain and suffering, mental anguish, financial losses, and loss of spousal consortium.

The Hernia Mesh Lawsuit is Case No. 1:19-cv-00040 in U.S. District Court for the Western District of Louisiana, Alexandria Division.