Ethicon Physiomesh is “not safe”according to lawsuit. John Guerra, from Torrance California claims that the Ethicon Physiomesh patch used in his hernia repair causes severe health risks and complications. According to Guerra, he developed a chronic seroma and required many additional surgeries.
A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery. This fluid is composed of blood plasma that has seeped out of ruptured small blood vessels and inflammatory fluid produced by the injured and dying cells.
Seromas are different from hematomas, which contain red blood cells, and different from abscesses, which contain pus and result from an infection.
Guerra filed his product liability and personal injury claim in the U.S. District Court for the District of New Jersey, naming Johnson & Johnson and its Ethicon subsidiary as the defendants.
Guerra underwent a hernia repair to fix an incisional hernia with the Physiomesh hernia patch. Guerra developed severe complications caused by the mesh, developing a chronic seroma and had to undergo removal of the seroma cavity on many occasions.
What is Ethicon Physiomesh?
Ethicon Physiomesh has a sandwich design, with two layers of polyglecaprone-25, and two layers of polydioxanone film. The coating was applied to the polypropylene mesh to reduce adhesion, inflammation and help the mesh fix into the body.
According to Guerra’s complaint “The multi-layer coating of Defendants’ Physiomesh is cytotoxic, immunogenic, and not biocompatible, which causes or contributes to complications such as delayed wound healing, inflammation, foreign body response, rejection, infection, and other complications.”
As a result of the design defects, Guerra alleges that Ethicon Physiomesh was not safe for its intended purpose as a hernia repair mesh.
Ethicon Physiomesh 2016 Recall
In June 2016, Ethicon recalled Physiomesh hernia mesh products worldwide, due to a high rate of injuries and revisions among patients who had the patch implanted. According to Ethicon, they have unable to identify or correct the underlying cause of the complications and side effects.
Ethicon termed the recall as a “market withdrawal” in the United States. Ethicon asked hospitals to return all unused implants and announced that it does not intend to return the product to the market.
Ethicon Physiomesh Federal Multidistrict Litigation
Recently, the U.S. Judicial Panel on Multidistrict Litigation (JPML) agreed to establish coordinated pretrial proceedings in the federal court system to U.S. District Judge Richard Story in the Northern District of Georgia.
This centralization and consolidation of federally filed cases is called Multidistrict Litigation or MDL and is a common practice in complex pharmaceutical and medical device litigation where similar injury facts have been alleged.
Dr. Shezad Malik law firm continues to investigate Ethicon Physiomesh personal injury claims from across the country. If you or a loved have been injured by Ethicon Physiomesh, including perforation, pain, infections and re-do surgery, please contact our office at 214-390-3189 immediately for your free consultation.