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The failure of an Ethicon Physiomesh patch used during a laparoscopic hernia repair allegedly caused a California woman to suffer severe pain, recurrent hernia, adhesions and other complications, according to a product liability lawsuit filed last week.
Santa Amalia Alvarez filed the complaint (PDF) against Johnson & Johnson and it’s Ethicon subsidiary in the U.S. District Court for the Eastern District of California, indicating that the unique design of the Physiomesh hernia repair mesh was defective, and caused her injuries.
Ethicon Physiomesh is unlike other hernia repair products, as it involves five distinct layers, which the manufacturer claimed were designed to improve performance. However, Alvarez claims that the multi-layer Physiomesh coating prevents fluid escape, which leads to seroma formation, infections and other complications.
After receiving a higher-than-expected number of similar reports involving hernia mesh failures, an Ethicon Physiomesh recall was issued last year, withdrawing the product from the market worldwide.
Alvarez indicates that Ethicon Physiomesh was used during her laparoscopic hernia repair surgery in October 2014. However, less than a year later, in July 2015, she had to undergo another procedure after the hernia returned.
During the second procedure, doctors discovered that the Physiomesh had failed to incorporate, resulting in the edge slipping down into the hernia. She suffered several adhesions, and incarceration of the omentum and bowel. During the second procedure another Physiomesh was used, but again she later suffered hernia recurrence, pain, additional adhesions and scarification.
“Defendants’ Physiomesh was defectively designed, was not reasonably safe for its intended use in hernia repair and the risks of the design outweighed any potential benefits associated with the design,” the lawsuit states. “As a result of the defective design of Physiomesh, there was an unreasonable risk of severe adverse reactions to the mesh or mesh components including, chronic pain; recurrence of hernia; foreign body response; infection; rejection; inadequate or failure of incorporation/in-growth; migration; scarification; deformation of mesh; improper wound healing; excessive and chronic inflammation; adhesions to internal organs; erosion; abscess; fistula formation; granulomatous response; seroma formation; nerve damage; tissue damage and/or death; and other complication.”
The case joins a growing number of Ethicon Physiomesh lawsuits filed by individuals nationwide who have experienced complications following laparoscopic hernia repair in recent years.
Given the similar questions of fact and law presented in cases pending throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) decided last month to establish coordinated pretrial proceedings, centralizing all cases before U.S. District Judge Richard Story in the Northern District of Georgia to reduce duplicative discovery, avoid contradictory pretrial rulings and to serve the convenience of the parties, witnesses and the courts.
Alvarez’s lawsuit will be transferred to the federal multidistrict litigation (MDL), which currently includes nearly 100 other claims. However, as hernia mesh lawyers continuing to review and file additional cases in the coming weeks and months, it is expected that several thousand complaints will ultimately be included in the litigation.