Covidien Parietex Lawsuit Filed Over Hernia Mesh Failure, Need For Revision Surgery

The Covidien Parietex lawsuit indicates a defective collagen film can lead to adhesions and other hernia mesh complications.

A product liability lawsuit filed against Covidien and its parent company, Medtronic, claims that the Parietex Composite hernia mesh is defective and prone to failure, resulting in hernia complications and the need for revision surgery.

The complaint (PDF) was filed by Deborah Luzey in the U.S. District Court for the District of Massachusetts on January 19. In addition to Covidien and Medtronic, the lawsuit also names Tyco International, Surgical Solutions Group, and Sofradim Corp. as defendants, for their role in manufacturing, selling and distributing Covidien Parietex mesh for use during hernia repair surgery.

Covidien Parietex is a two-sided surgical mesh, which has been commonly used in recent years during certain ventral hernia repairs. The composite mesh is coated with a protective, absorbable collagen barrier that is intended to prevent tissue attachment. However, the lawsuit alleges this barrier and other design elements actually result in a high rate of failure and hernia mesh complications.

According to allegations raised in the Covidien Parietex lawsuit, the manufacturers designed and sold a defective and unreasonably dangerous product, which has also been linked to reports of painful and debilitating hernia mesh complications by individuals throughout the U.S.

Luzey indicates that she received a Covidien 15cm Parietex Composite mesh in April 2018m when she underwent ventral hernia repair surgery. However, later that year, in August 2018 while undergoing surgery for a chronic umbilical wound, Luzey’s surgeon discovered a purulent draining wound near the ventral repair site. The surgeon also found adhesions and subcutaneous tissue going into the mesh, which indicated the mesh’s collagen film barrier did not last long enough for the body to heal. The doctor decided to explant the defective mesh.

“Although Defendants represented to health care providers that the collagen film would prevent or reduce adhesions, they failed to warn health care providers that adhesions would still form long after the collagen film resorbs, and therefore at best would provide only temporary adhesion reduction,” Luzey’s lawsuit states. “Further, Defendants did not warn health care providers that when the collagen film inevitably degraded, the exposed polyester or polypropylene would become adhered to the bowel or visceral tissue.”

The complaint raises claims similar to those presented in a number of other Covidien Parietex hernia mesh lawsuits being pursued by individuals who have experienced problems associated with the design.

In addition to claims over problems with Parietex mesh, there are also a number of similar allegations being raised in complaints filed over other hernia repair products sold over the past decade, including Bard hernia mesh lawsuits, Atrium C-Qur lawsuits and Ethicon Physiomesh lawsuits.

Claims involving each of those hernia mesh products have since been consolidated in the federal court system, as part of different multidistrict litigations (MDLs). However, there are currently no consolidated pretrial proceedings established for the Covidien Parietex lawsuits.