Atrium Prolite Mesh Lawsuit Filed Over Hernia Repair Failure, Revision Surgery

After experiencing severe complications following a hernia repair, a Kentucky man has filed a product liability lawsuit alleging that design problems with the Atrium ProLite hernia mesh resulted in premature failure and the need for additional surgery to remove the mesh from his body.

The complaint (PDF) was filed by Joseph J. Sims in the U.S. District Court for the Western District of Kentucky on December 14, indicating that Atrium Medical sold the Prolite surgical mesh in a defective and unreasonably dangerous condition, since it is prone to result in adhesions even when it has not come into contact with the intestines and even if it is implanted correctly.

Sims received the Atrium Prolite mesh in May 2015, during a bilateral laparoscopic inguinal hernia repair procedure. Following the surgery, Sims indicates that he began to suffer severe pain and other health problems, which ultimately resulted in the need for hernia revision surgery to remove the mesh in February 2017.

The surgeon overseeing the operation found that Sims was suffering from significant adhesions from the hernia mesh, and was unable to separate the peritoneum from the Prolite. As a result the hernia revision resulted in the need to cauterize the mesh from Sims’ pubic tubercle, finding more adhesions to the pubis and iliac joint.

Sims underwent a second revision surgery in September 2017 to remove more of the mesh. However, the Atrium hernia mesh removal has not alleviated his constant pain, the lawsuit notes.

“Plaintiff suffered chronic pain both before and after his hernia repair surgeries to remove the defective ProLite hernia mesh,” Sims’ lawsuit states. “He was unable to continue working at his job due to recurrent hernia problems, and remains unable to work today.”

The Atrium ProLite is a flat sheet, knitted, polypropylene hernia mesh approved by the FDA in 2009, through the agency’s controversial 510(k) fast-track approval process. The lawsuit indicates that Atrium failed to perform adequate testing on the mesh to determine its risks and benefits before it was placed on the market.

Similar allegations have been raised against the manufacturer in other claims over the Atrium C-Qur hernia mesh. Several hundred Atrium C-Qur lawsuits are pending in the federal court system, each raising allegations that the surgical mesh used during hernia repair procedures was defectively designed and unreasonably dangerous, causing individuals to experience painful and debilitating complications, often resulting in the need for complex surgery to remove the device.

The Atrium C-Qur, pronounced “Secure”, was approved by the FDA in March 2006, featuring a polypropylene mesh with an outer coating of gel made from 3 fatty acids. However, this design has been linked to reports of severe infections, allergic reactions and other problems.

Given similar questions of fact and law raised in the cases, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established consolidated pretrial proceedings for all Atrium C-Qur cases in December 2016, centralizing all claims before U.S. District Judge Landya McCafferty in the District of New Hampshire to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and the judicial system.

The Atrium Prolite mesh lawsuits are not currently centralized as part of the MDL proceedings, so Sims’ case will proceed as a separate claim through pretrial discovery and litigation.