Ethicon Physiomesh blamed for injuries following Hernia Surgery according to a lawsuit. Amy Flood from Texas recently filed a product liability and personal injury claim in the U.S. District Court for the Eastern District of Texas over injuries caused by an Ethicon Physiomesh hernia mesh.
According to Flood, the Ethicon Physiomesh mesh is defective leading to increased risk of adhesions, bowel perforations, erosions, fistula formation, bowel strangulation and hernia incarceration.
Ethicon Physiomesh blamed for injuries following Hernia Surgery
Flood filed her injury claim against Johnson & Johnson the world’s largest pharmaceutical and medical device maker and its Ethicon subsidiary. The Ethicon Physiomesh hernia mesh device which was initially implanted laparoscopically caused a recurring hernia and severe adhesion injuries, and Flood had to undergo additional risky abdominal surgery.
Flood claimed that “the Defendants’ Physiomesh was defectively designed and/or manufactured, 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.”
Johnson & Johnson, Ethicon under fire over Hernia Mesh Devices
Johnson & Johnson makes many types of hernia mesh devices including the Proceed and Physiomesh. The Physiomesh device is exposed to many lawsuits alleging similar types of injuries as claimed by Flood.
Johnson & Johnson issued a worldwide Ethicon Physiomesh recall in 2016, after many reports of serious and catastrophic injuries from the device.
What is the problem with the Ethicon Physiomesh?
Ethicon released its Physiomesh products in 2010, utilizing the U.S. Food & Drug Administration’s (FDA) 510(K) program. This “fast track” loophole allows a medical device to come to market without any human clinical trials, as long as a manufacturer can show that it is “substantially equivalent” to another product previously approved by the agency.
Ethicon Physiomesh has a unique design with five distinct layers, that the company claims improves function. 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 experts, the design is defective in that the sandwich design and the Physiomesh coating blocks fluid to escape, causing seroma formation, infections, and other side effects.
Ethicon Physiomesh Hernia Mesh Multidistrict Litigation
The U.S. Judicial Panel on Multidistrict Litigation (JPML) approved a Multidistrict Litigation or MDL to coordinate pretrial proceedings and centralizing all cases before U.S. District Judge Richard Story in the Northern District of Georgia. The federal multidistrict litigation currently has over 100 Physiomesh injury claims according to the latest court data.
Dr. Shezad Malik law firm based in Dallas, Texas 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 redo surgery, please contact our office at 214-390-3189 immediately for your free consultation.