Johnson & Johnson’s Ethicon unit initiated a voluntary recall of their Ethicon Physiomesh Composite Mesh product line following an analysis of unpublished date from two hernia registries that demonstrated higher than average recurrence/reoperation rates.
According to the U.S. Food and Drug Administration (FDA), some of the most common complications from the use of physiomesh for hernia surgery repair were:
Physiomesh is made from polypropylene, which studies revealed breaks down in structure, causing the hernia to return or resulting in bacterial infections and other complications that often require another surgery. The FDA did not require clinical trials to prove its safety since it was approved under the 510(k) process, which fast-tracks approval, in April 2010.
In May 2016, Ethicon issued an Urgent Field Safety Notice, which encouraged healthcare personnel not to use some of their Physiomesh hernia patch products. Several lawsuits have been filed against Ethicon, alleging that the products were defectively designed due to its choice of plastic materials, which react to human tissues, and that it fails to actually fulfill its intended purpose.
Fibich, Leebron, Copeland & Briggs are experienced litigators who have prosecuted claims involving polypropylene mesh.
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