Urgent Hernia Mesh Warning and Who Is Eligible to File a Physiomesh Lawsuit
Ethicon hernia mesh has been pulled from markets worldwide due to its high rate of failure. Unspecified product defects have resulted in serious internal injuries to a large number of patients. Ranging from pain and infection at the implantation site to internal organ damage and the need for one or more revision surgeries, Physiomesh problems can result in severe and long-term injuries. This page provides full details about the Ethicon hernia mesh warning and the full range of various hernia mesh side effects.
What is Physiomesh?
Physiomesh hernia mesh is a synthetic product developed and marketed by Ethicon, a division of Johnson & Johnson. Hernia mesh is used in laparoscopic hernia repair surgeries to patch weak sections of the abdominal wall. These hernia patches are comprised of non-absorbable polypropylene fibers which are woven into a pliable fabric. The mesh is intended to be physiologically compatible with the body's natural abdominal tissues. Implantation is considered permanent, meaning it cannot be readily removed. Physiomesh hernia patch kits were manufactured in a variety of shapes and sizes.
Ethicon Warns of Hernia Mesh Problems
In May of 2016, Johnson & Johnson's Ethicon unit issued an Urgent Field Safety Notice on the topic of side effects and defects traced to its Physiomesh Flexible Composite Mesh. Hernia mesh risks have been found to outweigh the product's potential benefits. Physiomesh problems include pain, infection, hernia recurrence, adhesion (scar-like tissues form, attaching the internal abdominal tissues together), intestinal blockage, bleeding, and perforation of internal tissues and organs.
The company was informed of hernia mesh defects by two large, unpublished studies originating in Denmark and Germany, respectively. These hernia registries, known as the Herniamed German Registry and the Danish Hernia Database, each showed evidence of an alarming trend: patients implanted with Ethicon hernia mesh for the laparoscopic repair of ventral hernia had far worse outcomes than patients implanted with a comparable product to repair the same malady.
Physiomesh Problems Not Found in Safety Testing
Ethicon hernia mesh was approved in 2010 through the FDA's 510k approval process for medical devices. This particular method is a fast track process intended to accelerate the approval of new medical devices that are substantially equivalent to a device that has already met market approval. The 510k process requires only animal testing; therefore, these hernia patch kits were not tested on humans prior to market release, nor were they tested for their specific application in the abdomen. In general, synthetic meshes are the preferred method of hernia repair as these medical devices typically promote rapid healing and result in fewer cases of pain and infection. Only after thousands of patients were implanted with hernia mesh and suffered severe Physiomesh side effects did the company discover the product's defects.
In this case, Physiomesh was fast-tracked on the basis of another hernia mesh from Ethicon known as Proceed. Proceed was recalled because of a defect that caused adhesion and bowel fistulas. Ethicon's hernia mesh causes adhesion and hernia recurrence due to its incompatibility with organic tissues in the abdominal wall.
Hernia Mesh Injury Lawsuits
Persons and the family members of persons who have experienced severe side effects related to the failure of Ethicon Physiomesh may be eligible for meaningful compensation through filing a hernia mesh injury lawsuit, the purpose of which is to hold Ethicon accountable for its disregard of product and consumer safety.
National Physiomesh Lawyers
These hernia mesh lawyers have extensive experience in the realm of product liability litigation, representing individuals and families against the interests of large corporate entities. Working on a contingency basis, these Physiomesh attorneys will charge no legal fees unless they win on your behalf.