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Ethicon Physiomesh Lawsuit News

Johnson & Johnson Could Have Been More Forthcoming in Withdrawing Physiomesh

Ethicon Inc., maker of Physiomesh Flexible Composite Hernia Mesh, and parent company Johnson & Johnson dragged their feet before eventually pulling the defective product from the market

Friday, September 14, 2018 - Physiomesh received its initial FDA approval in April of 2010 a mere 4 months from its initial application. Rushing the product to market using the flawed FDA "fast-track" approval process is likely responsible for failing to adequately test the device on humans before launching the product. Ethicon was aware of the complaints patients were making yet did nothing to warn consumers. Instead, Johnson & Johnson may have put profits ahead of patient safety.

Physiomesh is made from the same material, polypropylene, that has proven to fail when placed within the human body. Such findings were readily available to Ethicon and Johnson & Johnson years ago when The National Institute of Health (NIH) conducted animal research that concluded polypropylene corrodes rapidly when placed inside an animal. "New Zealand White female breeder rabbits were implanted with polypropylene mesh, ADSC-fixed polypropylene mesh in the abdomen. After 4 weeks, adhesion was performed and the erosion of the mesh was evaluated. It was found that polypropylene mesh, ADSC-fixed polypropylene mesh all had different degrees of corrosion and adhesion, but polypropylene mesh was more corroded." It is inconceivable the Ethicon and Johnson & Johnson could have ignored this vital information.

Physiomesh Flexible Composite Mesh was removed from the market globally on May 25, 2016, due to higher than acceptable revision surgeries associated with the product as reported to the German hernia registry, Herniamed. Physiomesh patients experienced chronic, recurring pain, infections, inflammation, and the recurrence of their hernia as the reasons forcing them to need revision surgery. The National Institute of Health noted that greater than 10% of Physiomesh patients need revision surgery, an unacceptably high percentage. Ethicon voluntarily recalled Physiomesh in the US prompting other countries to follow suit and force a Physiomesh recall. In addition to the worldwide voluntary recall, Canadian health ministry Health Canada issued a mandatory recall of Physiomesh shortly afterward. In Australia, Physiomesh was recalled by the Australian Therapeutic Goods Administration on June 9th. Surgeons were required to immediately stop using the device and to return all unused items.

Physiomesh pulls away from a hernia that it was intended to support, stabbing the underlying tissue, and causing sharp pain. Physiomesh is made from flexible yet firm polypropylene plastic due to substances initial strength. The problem is that the body aggressively attacks this foreign substance and is very good at degrading it. When that happens the device tends to shrink and buckle and pull away from a hernia it was intended to support. It is then free to travel within the abdomen, often landing on and puncturing the intestines. When Physiomesh pulls away from its original location the hernia usually reoccurs. In instances of severe pain, revision surgery is required to locate and remove Physiomesh as well as the underlying tissue that it has randomly reattached itself to with scar tissue formation.

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Lawyers for Ethicon Physiomesh Lawsuits

OnderLaw, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others. The Onder Law Firm has won more than $300 million in four talcum powder ovarian cancer lawsuits in St. Louis. Law firms throughout the nation often seek its experience and expertise on complex litigation.