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A Michigan man alleges that the design of the Ethicon Prolene patch makes it unsafe for use during hernia repair, indicating in a recently filed lawsuit that he experienced numerous complications from the hernia mesh, including the entangling of his spermatic cord.
The complaint (PDF) was filed by Terrence Smith and his wife, Lucy, in New Jersey Superior Court on July 5, naming Johnson & Johnson and it’s Ethicon subsidiary as defendants.
Smith indicates that a 4.5cm by 10cm patch of the Ethicon Prolene Hernia System was implanted in February 2007, for repair of a right inguinal hernia. However, he had to have the patch removed in December 2009, during a hernia revision surgery.
According to the complaint, his surgeon discovered that the Prolene Hernia Mesh had become attached to the inguinal canal floor and had encircled his spermatic cord, as well as his ileal inguinal nerve. This resulted in severe pain, inflammation, chills, nausea, extreme weight loss, loss of appetite and will likely require additional surgeries in the future.
The complaint raises similar allegations to those presented in a growing number of hernia mesh lawsuits filed over Ethicon products, which maintain that multi-layer hernia patch design is defective and unfit for use in human beings. Smith also indicates that Ethicon and Johnson & Johnson never performed any clinical trials or studies before marketing the Ethicon multi-layered hernia mesh product line, which includes the Prolene Hernia System, as well as the recalled Physiomesh product.
“The Prolene Hernia System, which incorporates the Ethicon Multi-Layered Hernia Mesh design, created an unreasonable risk of harm to Terrence Smith,” the lawsuit states. “When implanted, the unreasonable risk of injury and harm, including pain, dense adhesion formation, organ complications, mesh shrinkage, hernia recurrence, seroma and fistula formation, and infection—whether due to a prolonged and pronounced inflammatory response caused by the multiple mesh layers, degradation of polymers, non-conforming subcomponents, or some other mechanism—renders Defendants’ Prolene Hernia System, an Ethicon Multi-Layered Hernia Mesh, a defective product, unsafe for its intended use.”
In addition to other Ethicon mesh lawsuits, such as Ethicon Physiomesh lawsuits, there are also a number of Bard hernia mesh lawsuits and Atrium C-Qur lawsuits pending nationwide over complications associated with those other polypropylene designs.
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 manufacturers in the coming weeks and months.