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Ethicon Physiomesh Lawsuit News

Ethicon Fails To PinPoint the Reason for Physiomesh Failures

By failing to determine the exact reason Physiomesh fails, hernia mesh surgeons and their patients are left in the dark as to how to fix the problem

Tuesday, August 21, 2018 - Ethicon issued an Urgent Field Safety Notice alerting medical professionals to stop selling Physiomesh telling them "The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries. Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristic, operative and patient factors) but has not been able to fully characterize these factors. Consequently, Ethicon has not been able at this time to issue\further instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to recall ETHICON PHYSIOMESH Composite Mesh from the global market."

The Ethicon Physiomesh Composite Mesh is unique in the industry both in its design as well as in the materials used to build the device. According to the company, "ETHICON PHYSIOMESHTM Flexible Composite Mesh is a sterile, low profile, flexible composite mesh designed for the repair of hernias and other fascial deficiencies. The mesh product is composed of a nonabsorbable, macroporous polypropylene mesh laminated between 2 polyglecaprone-25 films." Although the product has been deemed "substantially similar" to other hernia mesh devices already on the market, one unique characteristic is that it is made from polypropylene, a substance never designed to be placed permanently inside the human body. Polypropylene is a petroleum-based plastic that is known as a food packaging product for its strength and durability. As a result of inadequate pre-market product testing regulators failed ascertain, as had the National Institute of Health earlier, that polypropylene degrades when attacked by the body's natural defensive mechanism and causes the device to buckle, shrink and pull out the sutures that were used to keep the mesh over the top of a hernia. As a result, Physiomesh has caused crippling pain, inflammation, infections, allergic reactions, organ perforation, and intestinal blockages. So complete is the breakdown of Physiomesh and polypropylene that a judge recently ordered all those intending to hire a Physiomesh lawyer and file a claim against Ethicon to instruct their revision surgeon to save and preserve the damaged Physiomesh when it is removed and to send it to a special medical storage company in Florida.

The huge financial success of the Ethicon Physiomesh hernia repair device makes it exceptionally suspicious when a company voluntarily and permanently pulls it from the market, especially when no reason for the recall is given. It is only natural to ask why the company is taking this action and what exactly the company is hiding. What do Ethicon and its parent company Johnson & Johnson know about the reasons Physiomesh does not work? Rather than attempt to correct the problem and advise surgeons as to how to safely implant and remove Physiomesh if need be at a later date, Ethicon and Johnson & Johnson have decided to keep quiet and just stop selling or servicing Physiomesh altogether. Such a callous disregard for the safety of their patients adds yet another level to the intrigue surrounding the market withdrawal.

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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.