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Ethicon Will Not Reintroduce Physiomesh

Something must be seriously wrong for an industry leader like Johnson & Johnson to forgo billions in revenue and take a medical device off of the market

Monday, September 10, 2018 - Companies that issue voluntary recalls of a best-selling medical device usually do so to test the product further and to make changes to correct a problem. The company then reintroduces the product as a new and improved version. That is why it seemed so unusual when on June 13, 2016, Ethicon Inc., issued a voluntary worldwide market withdrawal of Physiomesh Flexible Composite Hernia Mesh through Health Canada along with the statement that the recall was permanent. According to, the reason for the recall was that after reviewing the data from independent unpublished hernia databases in Germany and Denmark, hernia recurrences severe enough to require revision surgery were above average. Ethicon failed to cite a reason why Physiomesh had such a high failure rate but scientists have surmised that the problem may lie in the Polypropylene fibers that are woven throughout the hernia repair screen. A few days earlier the market withdrawal of Physiomesh Flexible Composite Mesh was issued through the Australian health ministry. The market withdrawal specifies that the product being recalled was the Ethicon Physiomesh used to reinforce hernia repair used in laparoscopic surgery.

During laparoscopic surgery, surgical equipment and micro cameras are inserted into an incision less than a centimeter in length. Physiomesh is then inserted over the top of the site of a hernia and below the muscle, fat and abdominal wall in order to reinforce the area. Physiomesh is sutured minimally in place as the interwoven Polypropylene fibers are designed to create microscopic abrasions that cause scar tissue to develop and hold the device in place. Unfortunately, in an unacceptably high number of patients, the body's own immune system attacks the Polypropylene and other elements that comprise Physiomesh causing the device to shrink, crumple, buckle, deteriorate and painfully pull loose from the site of the surgery. Physiomesh or pieces thereof are then free to migrate to other parts of the body, often to the lowest part of the abdominal cavity and clife-threatening intestinal blockages.

As previously noted, voluntarily removing a medical device from the market and losing the billions in revenue that it generates is unusual, to say the least. One can speculate on the reasons this was done but in all likelihood, Johnson & Johnson acted based on the billions in lawsuits they were faced with when their other similar medical device, the transvaginal mesh, also failed and women became permanently incontinent. More than 700 women have sued the company claiming that the transvaginal mesh ruined their lives with permanent incontinence and debilitating pain. Ethicon Physiomesh hernia patient that require revision surgery to locate and remove Physiomesh are urged to consult a knowledgeable Physiomesh attorney to see if they qualify to file a claim against Ethicon and its parent company Johnson & Johnson for rushing an untested medical device to market.

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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.