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Physiomesh Withdrawn From Market to Limit Ethicon's Liability

When a medical device manufacturer voluntarily pulls a billion-dollar product from the market you know that something must be very, very wrong

Saturday, June 30, 2018 - Physiomesh is a flexible composite mesh used during minimally invasive hernia repair surgery, but the adverse side effects are anything but minimal. Ethicon apparently viewed the Physiomesh failure situation so seriously that the Johnson & Johnson subsidiary issued a total global market withdrawal of the Ethicon Physiomesh hernia repair device in May of 2016, permanently pulling the product from the market rather than attempting to revise and improve the product. Ethicon sent an "Urgent Field Safety Notification" to all US medical personnel requiring them to discontinue the use of Physiomesh and return all unused portions immediately.

Although the voluntary market withdrawal of Physiomesh mentions no specific reason why the product was taken off the market, plaintiffs suing Ethicon point to the failure of the Polypropylene element of physiomesh. Plaintiffs allege that the plastic is "biologically incompatible" with human tissue and that Polypropylene triggers the body's natural auto-immune response to reject the foreign substance. Such a rejection results in Physiomesh shrinking and degrade causing it to pull free and drift from the intended spot. Physiomesh has been found in a patient's abdominal cavity embedded in the intestines where it causes blockages. When the Physiomesh graft is rejected, symptoms can include severe pain, puncturing organs, infections, seroma, sepsis, fistula and potentially death. Ethicon has gone on record as stating that the total market withdrawal was in response to European studies pointing to an unusually high number of revision surgeries Physiomesh patients were forced to undergo to remove the device, repair their hernia properly, and end their devastating pain.

Ethicon may have cut their losses short with Physiomesh, however, the company still faces thousands of lawsuits as Physiomesh disintegrates within patients, crumples, buckles pulls away from a hernia it was intended to support and migrates to other parts of the abdominal cavity. Ethicon and Johnson & Johnson were forced to pay millions of dollars in fines and settlements years earlier when their other mesh medical device, the transvaginal mesh, failed and left women with permanent incontinence and sterility. Ethicon was forced to recall its gynecological mesh that had already been implanted in more than 2 million women and as a result of the transvaginal mesh failure over 100,000 women filed suit claiming the company brought a faulty medical device to market. The staggering number of transvaginal mesh lawsuits ranks second only to asbestos in terms of the number of patients adversely affected. Rather than push forward and defend and improve Physiomesh, Ethicon and Johnson and Johnson pulled the medical device and must now face the consequences of bringing yet another faulty medical device to market without adequately testing it first.

If you have had Physiomesh hernia repair surgery and have required a second revision surgery to remove the device and repair the original hernia you may consider consulting an experienced Physiomesh attorney to see if you qualify to file a claim against the company and be compensated for your medical expenses, lost income, pain and suffering and all other related expenses.

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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.