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Complications following hernia repair with an Ethicon Proceed patch have resulted in a product liability lawsuit against the manufacturer, alleging that the hernia mesh is defective and presents an unreasonable health risk for patients.
The complaint (PDF) was filed by Jeannine Michaels in New Jersey Superior Court on October 9, naming Johnson & Johnson and its Ethicon subsidiary as defendants.
Michaels, of Pennsylvania, underwent hernia repair procedures in February 2010 and September 2014, both of which involved the use of a multi-layered hernia mesh product, known as the Ethicon Proceed. During the first procedure, she received a 30 x 15cm patch of Ethicon Proceed Surgical Mesh. However, during the second procedure, she received two additional Ethicon Proceed Patches; one of which was 20 x 30cm and the other was 10 x 15cm.
In October 2016, Michaels had to undergo additional surgery to remove the hernia mesh due to complications she was experiencing. During the removal surgery, it was discovered that she suffered mesh infection, chronic draining, and a possible small bowel fistula.
According to allegations raised in the lawsuit, the injury was caused by problems with the Ethicon Proceed mesh, indicating that she continues to suffer and that she is at higher risk of severe complications during abdominal surgeries in the future, to the extent that such surgeries, even if necessary, may not be possible.
The lawsuit indicates that the manufacturers failed to warn Michaels and her doctors about the true risks of Ethicon Proceed hernia mesh complications, failed to perform any clinical trials or studies on the device’s safety and effectiveness, and continues to market the mesh without warning of the potential health risks.
“The Ethicon Multi-Layered Hernia Mesh created an unreasonable risk of harm to Jeannine Michaels,” the lawsuit states. “The unreasonable risk of pain, dense adhesion formation, bowel complications, mesh shrinkage, hernia recurrence, seroma and fistula formation, and infection, whether from a prolonged and pronounced inflammatory response caused by the multiple layers, degradation of polymers due to exposure to gamma irradiation, non-conforming subcomponents, or some other mechanism, renders the Ethicon Multi-Layered Hernia Mesh a defective product.”
The case joins a growing number of Ethicon hernia mesh lawsuits pending in courts nationwide. In addition to the Ethicon Proceed and Prolene products, hundreds of cases have been filed over similar problems with Ethicon Physiomesh, which is another multi-layer polypropylene hernia patch that was recently recalled from the market worldwide amid reports of problems.