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Problems with the design of Ethicon Proceed mesh allegedly caused a Louisiana woman to suffer painful and debilitating hernia repair complications, including an infection and bowel perforation that resulted in the need for additional surgery to remove the mesh just a day after it was implanted, according allegations raised in a recently filed product liability lawsuit.
Robbin Mitchell and her husband, Alton, filed a complaint (PDF) against Johnson & Johnson and its Ethicon subsidiary earlier this week in the U.S. District Court for the Western District of Louisiana, indicating that the manufacturer knew that Ethicon Proceed mesh was unreasonably dangerous and defective, and likely to cause severe complications.
Mitchell underwent hernia repair surgery on January 12, 2018, at which time Ethicon Proceed Surgical Mesh was implanted. However, the complaint indicates that on January 13, just a day later, she underwent another surgery to have the mesh removed due to pain, infection and bowel perforation.
The lawsuit indicates that the manufacturers failed to warn Mitchell and her doctors about the true risks of Ethicon Proceed hernia mesh complications, failed to perform any clinical trials or studies to properly evaluate the safety and effectiveness of the product, and continues to market the hernia mesh without warning of the potential health risks.
One of the problems with Ethicon Proceed mesh appears to be how it is manufactured, according to the lawsuit. Ethicon Proceed mesh is composed of a layer of Oxidized Regenerated Cellulose (ORC), which is attached to a layer of light-weight polypropylene mesh with polydioxanone. It is a design not used in any other hernia mesh products, and Mitchell’s lawsuit claims the layered design allows bacterial contamination to proliferate. These design defects can lead to delamination of the two layers, resulting in seroma formation, according to the filing.
“When the ORC degrades and delaminates, the human body is exposed to the light-weight polypropylene mesh and polypropylene is toxic when inserted into the human body,” the lawsuit notes. “Polypropylene develops and promotes toxicity once placed in the human body because the cells attack polypropylene as a foreign substance, which promotes a foreign body response resulting in complications. Moreover, the light-weight polypropylene mesh used in Proceed Surgical Mesh is weak and more prone to tearing and blow outs.”
The case joins a growing number of similar Ethicon hernia mesh lawsuits pending in courts nationwide. In addition to complaints over Ethicon Proceed products, hundreds of Ethicon Physiomesh lawsuits have been filed over another multi-layer polypropylene hernia patch, which was subsequently recalled from the market worldwide amid reports of problems.