By Andrew Emett
A lawsuit was recently filed against Ethicon and Johnson & Johnson for manufacturing an allegedly defective product while failing to adequately inform the plaintiff and his physician of the severe health risks associated with his hernia mesh implant. Although the plaintiff continues to suffer complications due to the hernia mesh, he is currently at higher risk for further complications and might no longer be a candidate for future abdominal surgeries.
On June 22, 2015, Franklin C. Robinson was implanted with a 25 by 20 cm Ethicon multi-layered Physiomesh in order to repair an umbilical hernia. Suffering from complications caused by the implant, Robinson underwent revision surgery on February 29, 2016.
During the revision surgery, doctors were only able to remove part of the hernia mesh after discovering extensive adhesiolyses, which are bands of scar tissues. On June 20, 2016, Robinson underwent another revision surgery in which doctors removed part of his mesh and found more adhesiolyses.
According to the lawsuit filed by Robinson on April 25, in New Jersey Superior Court, he “experienced and/or continues to experience severe pain, nausea, diarrhea, chills, inflammation, loss of appetite, and extreme weight loss which have impaired his activities of daily living.” Because he is at higher risk of severe complications during abdominal surgery, future surgeries to fix complications caused by the Physiomesh may no longer be possible.
“Ethicon Multi-Layered Hernia Mesh created an unreasonable risk of harm to Plaintiff Franklin Robinson,” the lawsuit says. “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 Ethicon Multi-Layered Hernia Mesh a defective product.”
The lawsuit continues, “Reassurances of device safety were made through direct promotional contact by Defendants’ sales representatives and distributors, through word-of-mouth from Defendant’s physician/technical consultants, and/or through industry targeted promotional materials. Despite these reassurances, the defective design and manufacture of Ethicon MultiLayered Hernia Mesh continued to elicit severe and chronic inflammatory responses, resulting in adhesion formation, bowel injuries, mesh contracture, pain, hernia recurrence, infections, seromas, fistulas, erosion, extrusion, and additional complications.”
In 2016, Ethicon voluntarily issued a worldwide Physiomesh recall due to higher-than-average revision rates after use. According to data collected from two large independent hernia registries, the flexible composite mesh resulted in higher than average rates of recurrence after laparoscopic ventral hernia repair compared to other meshes.