Parietex Lawsuit Filed Over Hernia Recurrence and Mesh Migration
A defectively designed Covidien Parietex patch caused a hernia recurrence, after the mesh migrated out of position, resulting in severe pain and permanent injuries, according to allegations raised in a recently filed lawsuit.
Tracy Matthews filed the complaint (PDF) in the U.S. District Court for the District of Massachusetts on July 22, naming Covidien Inc, its parent company, Medtronic, as well as Tyco International and Sofradim Corp. as defendants.
Covidien Parietex is a two-sided hernia patch, which has been commonly used in recent years during certain ventral hernia repair surgeries. 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, including the use of polyester, actually result in a high rate of failure and complications with the hernia patch.
Matthews indicates she underwent left inguinal hernia repair surgery in August 2020, at which time she was implanted with a Parietex Pro Grip hernia mesh. However, when she went to undergo another surgery in July 2021, due to groin pain, surgeons discovered the Parietex mesh had migrated upwards, creating a gap which led to a hernia recurrence.
The mesh migration and hernia recurrence surgery has left Matthews with chronic and debilitating pain, according to the lawsuit. She alleges the manufacturers knew about similar problems and the risk of mesh migration, yet failed to warn patients and the medical community, and failed to take actions to change the design to mitigate those risks.
“Defendants omitted mention of the Device’s risks, dangers, defects, and disadvantages when they advertised, promoted, marketed, sold and distributed them as safe to regulatory agencies, health care providers, Plaintiff and other consumers,” the lawsuit states. “But Defendants knew or should have known that the Hernia Mesh Device was not safe for its intended purposes, and that it would and did cause serious medical problems, including severe and permanent injuries and damages—and in some Plaintiff, catastrophic injuries and death.”
The complaint joins a growing number of similar hernia mesh lawsuits being filed over problems with the Covidien Parietex hernia patch, which were recently centralized in the federal court system as part of a multidistrict litigation (MDL) before U.S. District Judge Patti B. Saris in the District of Massachusetts, for coordinated discovery and pretrial proceedings.
At least three separate MDLs have also been established for problems with other hernia mesh products sold over the past decade, including Bard hernia mesh lawsuits, Atrium C-Qur lawsuits and Ethicon Physiomesh lawsuits.
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