Two new hernia mesh lawsuits have been filed on behalf of plaintiffs who allegedly suffered serious complications following implantation of Ethicon, Inc.’s Physiomesh product and C.R. Bard, Inc.’s Ventralex ST device.
According to a complaint filed in the U.S. District Court, Eastern District of Louisiana, on September 29th, Richard Stipelcovich was implanted with C.R. Bard’s Ventralex ST implant in October 2016.
By April 2017, he was forced to undergo hernia revision surgery, due to excruciating abdominal pain and hernia recurrence.
The complaint alleges that Stipelcovich continues to suffer permanent injures due to the defective nature of Ventralex ST hernia mesh.
“Before Plaintiff suffered the injuries complained of herein, Defendants were on notice of numerous bodily injuries caused by the Product, and based thereon, Defendants knew or should have known that the Product caused an unreasonably high rate of infection, extrusion, perforation, chronic pain and/or abscess in people implanted with the Product,” the complaint states.
“Even through Defendants had known or should have known that the Product created a foreseeable, unreasonable risk of harm to those patients into whom they were implanted, Defendants continued to market the Product in the United States. Defendants have sold thousands of Product in the United States.”
Amy Flood’s Ethicon hernia mesh lawsuit was filed October 9th in the U.S. District Court, Eastern District of Texas, just two years after she was laparoscopically implanted with Physiomesh Composite mesh, catalog number PHY1015V, to treat an incisional hernia.
According to Flood’s complaint, the allegedly defective nature of that device resulted in hernia recurrence, as well as severe physical pain and mental anguish that continues to this day. Flood further claims that her complications were the result of Physiomesh’s unique multi-layer design, as well as the polypropylene used in the hernia mesh.
“The degradation of this multi-layer coating caused or exacerbated an intense inflammatory and foreign body reaction. Once exposed to the viscera, the polypropylene mesh will inevitably adhere to the viscera, initiating a cascade of adverse consequences,” the complaint states. “Any purported beneficial purpose of the multi-layer coating (to prevent adhesion to the internal viscera and organs) was non-existent; the product provided no benefit while substantially increasing the risks to the patient.”
Flood also points out that Ethicon conducted a worldwide market withdrawal of all Physiomesh Flexible Composite products in May 2016, after data suggested that the devices were associated with high rates of recurrence and revision surgery, issuing an “Urgent Field Safety Notice” overseas that characterized the action as a “voluntary product recall.”
“However, in the United States, Defendants failed to issue a nationwide recall, opting instead to simply remove the product from shelves and cease further sales within the United States,” the lawsuit states. “This notice was not sent to patients implanted with the device, nor were physicians instructed to immediately remove the device. Instead, the recall instructed health care practitioners to “continue to follow those patients in the usual manner.”