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According to allegations raised in a product liability lawsuit filed by a Georgia man, problems with Ethicon Physiomesh caused the hernia patch to erode into his intestines, leaving him with severe injuries and complications.
The complaint (PDF) was filed by Henry Lee Brown in the U.S. District Court for the Northern District of Georgia on February 24, indicating that Johnson & Johnson and it’s Ethicon subsidiary sold a defective and dangerous hernia mesh product, which was susceptible to erosion, perforation, adhesion, fistula formation and bowel strangulation or hernia incarceration, as well as other problems.
Brown indicates that a 15cm x 20cm patch of Ethicon Physiomesh was implanted in his abdomen for hernia repair. However, the patch subsequently failed and eroded into his intestines, resulting in the need for an invasive surgery to remove the Physiomesh. The complications required surgical resection of Brown’s small bowel to remove adhesions, and resulted in the need for another surgery to repair the hernia the Physiomesh patch was originally implanted to treat.
Ethicon Physiomesh was introduced in 2010, featuring a unique design not found in any other hernia patch, with a total of five distinct layers. The hernia patch contains two layers of polyglecaprone-25 (“Monocryl”) film covering two underlying layers of polydioxanone film (“PDS), which in turn coat a polypropylene mesh.
While the multi-layer coating was marketed and promoted as a means to prevent adhesion and inflammation, as well as facilitate incorporation of the mesh into the body, it has actually been linked to a high rate of intense inflammatory and chronic foreign body response, leading to issues.
An Ethicon Physiomesh recall was issued for certain products in May 2016, after the manufacturer failed to identify fix for the large number of adverse events reported worldwide. While the action was classified as a “market withdrawal” in the United States, the manufacturer asked that all hospitals return unused implants and indicated that it will not be returning the device to the market.
“The multi-layer coating provides a breading ground for bacteria in which the bacteria cannot be eliminated by the body’s immune response, which allows infection to proliferate,” according to the lawsuit filed by Brown. “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.”
Brown’s case joins a growing number of Ethicon Physiomesh lawsuits filed in recent months, each involving similar allegations on behalf of individuals who received the hernia patch in recent years. Over the coming weeks and months, it is widely expected that the manufacturer will face hundreds, if not thousands, of cases brought nationwide.