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The multi-layered design of the Ethicon Proceed hernia patch is defective and unreasonably dangerous, according to allegations raised in a recently filed lawsuit, indicating that users face an increased risk of hernia mesh complications.
Robert Esbrandt filed the complaint (PDF) this month in New Jersey Superior Court against Johnson & Johnson, and it’s Ethicon subsidiary, indicating that he suffered damages and permanent injuries due to the defective nature of the Ethicon Proceed mesh.
According to the lawsuit, Esbrandt underwent a hernia repair surgery in December 2011, during which an Ethicon Proceed was implanted into his body. However, in February 2013 and again in April 2014, he required revision surgery to have the patch removed, and he had to undergo a third revision surgery in January.
Esbrandt alleges that the multi-layered hernia mesh design was defective, resulting in the need for the patch to be removed from his body.
“Defendants knew that the oxidized regenerated cellulose layer of the Ethicon Multi-Layered Hernia Mesh was ineffective at preventing adhesion formation to the underlying polypropylene of the Proceed before Defendants set out to design the Proceed Ventral Patch in 2006, and even before Defendants set out to design the Proceed Surgical Mesh predicate device in 2003,” the lawsuit states. “Defendants designed, manufactured, and marketed the Ethicon Multi-Layered Hernia Mesh, despite long-standing knowledge that the materials utilized in the Proceed would cause dense adhesions, chronic pain, mesh shrinkage, bowel obstructions, and early hernia recurrence.”
The lawsuit indicates that the manufacturers failed to warn Esbrandt and his doctors about the true risks of Ethicon Proceed hernia mesh complications, failed to perform any clinical trials or studies to properly evaluate the safety and effectiveness of the product, and continues to market the hernia mesh without warning of the potential health risks.
The case joins a growing number of similar Ethicon hernia mesh lawsuits pending in courts nationwide, most of which involve problems with the previously recalled Physiomesh product, which is another multi-layer polypropylene hernia patch that was removed from the market after it was linked to reports of problems.
Esbrant presents claims of defective design, failure to warn, manufacturing defect, negligence and breach of warranty. He seeks both compensatory and punitive damages.