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The design problems with the Ethicon Prolene Hernia System increased the risk of hernia mesh complications and resulted in failure years after an Arizona man had the patch implanted, according to allegations raised in a recently filed product liability lawsuit.
The complaint (PDF) was filed by Dale Lind in the Superior Court of New Jersey on August 13, indicating that Johnson & Johnson and its Ethicon subsidiary sold a defective hernia repair system, which deviates from the standard single-layer mesh design by incorporating an additional layer of mesh that creates an unreasonable risk of harm.
Lind indicates he underwent a left inguinal hernia repair in January 2010, at which time he was implanted with an extended Ethicon Prolene Hernia Mesh product, which features a multi-layered design that has been linked to reports of mesh failure and the need for hernia revision surgery.
In October 2017, Lind indicates that he had to again undergo left inguinal hernia repair, along with revision surgery to remove the Ethicon Prolene mesh, because it had failed and had adhered to cord structures.
“The mechanism of failure in Plantiff’s device was a mechanism of failure that Defendants had marketed and/or warranted would not occur because of Ethicon Multi-Layered Hernia Mesh design and composition,” the lawsuit states. “The implanted device that Defendants marketed and warranted would not have failed but for the defective design and composition of Ethicon Multi-Layered Hernia Mesh.”
Lind’s lawsuit indicates that the mesh occupied two inguinal compartments instead of one, which resulted in “intense inflammatory and chronic foreign body response,” leading to the mesh stiffening, hardening, contracting, deforming, migrating and causing chronic and debilitating pain.
The mesh failure led to complications that were harder to treat and large amounts of tissue loss, according to the complaint.
Lind’s complaint raises allegations similar to those presented in other hernia mesh lawsuits filed in recent months against Ethicon over Prolene and other multi-layer hernia patch designs used in thousands of procedures nationwide.
In addition to claims involving Prolene mesh, Ethicon Physiomesh lawsuits have been filed over a similar product removed from the market in 2016, amid a large number of reports involving premature failure.
As individuals who have experienced complications following a hernia repair continue to investigate and review potential cases with lawyers nationwide, it is expected that tens of thousands of complaints may be brought against various hernia mesh manufacturers in the coming months.