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Physiomesh Failures Could be Ongoing Nightmare

If the polypropylene component of Physiomesh turns out to be the cause of its malfunction, tens of thousands of patients could be at risk

Thursday, August 2, 2018 - When Ethicon Inc. and Johnson & Johnson decided to pull Physiomesh from the US market, the decision signaled something must be very wrong with the medical device. In most cases, companies voluntarily recall a medical device to further test it and then reintroduce a new and improved version of the product. It is estimated that Physiomesh made up a good portion of the Ethicon's $4.8 billion profit, and the decision to forgo all that money has raised eyebrows in the legal community and elsewhere. Why on June 13, 2016, would Ethicon Inc. issue an urgent field notice to Canadian healthcare professionals announcing a voluntary, worldwide, and permanent market withdrawal of Physiomesh Flexible Composite Hernia Mesh?

Ethicon has come out and said that the reason for the recall was in response to an opinion from their own internal medical safety unit that reviewed the data from independent unpublished hernia databases in Germany and Denmark that showed Physiomesh has experienced nearly double the rate of device failure than its nearest competitor and that the failures were so severe that a revision surgery was necessary to remove the device and re-repair the patient's hernia. Ethicon determined that there were potentially multiple reasons and not one specific one for Physiomesh's failure rate, however, scientists think the problem may be the Polypropylene component of the hernia mesh device.

The Physiomesh screen is interwoven with Polypropylene fibers in order to strengthen it. According to the Physiomesh homepage, Ethicon relies on the advice of scientists at the National Institute of health for their decision to incorporate Polypropylene into the hernia mesh repair screens, highlighting the plastic's strength and flexibility when used to make plastic bags, straws, condiment containers, and medicine bottles. The NIH, however, also questions the use of Polypropylene within the human body. The NIH said "The long-term consequences of implantable polypropylene prosthetics are not without concern. The body generates an intense inflammatory response to the prosthetic that results in scar plate formation, increased stiffness of the abdominal wall, and shrinkage of the biomaterial. Reducing the density of polypropylene and creating a ''lightweight'' mesh theoretically induces a less foreign-body response, results in improved abdominal wall compliance, causes less contraction or shrinkage of the mesh, and allows for better tissue incorporation. A review of the laboratory data and short-term clinical follow-up is reviewed to provide a strong basis or argument for the use of ''lightweight'' prosthetics in hernia surgery." (1)

It appears that a large portion of the revision surgeries required by Physiomesh patients is due to the body rejecting and attacking the Polypropylene plastic as a foreign object. As a result, Physiomesh buckles, shrinks, crumples and pulls loose from atop the surgically repaired hernia it was intended to support. The device is then free to migrate to other parts of the body, the intestines in particular and cause dangerous and painful blockages that can require emergency surgery. Attorneys handling Ethicon Physiomesh hernia lawsuits continue to fight against the makers of faulty medical device products that are proven to be harmful.

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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.