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Ethicon's Physiomesh Composite Mesh Joins the Transvaginal Mesh as Recalled Failures

All that is required for a medical device to receive FDA approval is that it is substantially similar to another medical device that has already received approval

Saturday, September 22, 2018 - No pre-market testing on humans is required. Once reviewed by an expert panel of scientists, the device can be offered to the public. The problem with the FDA's fast-track approval process is that 99% of new medical devices today circumvent the rigorous scientific testing and are merely compared with another medical device without consideration as to whether or not the device has malfunctioned, been recalled, or the subject of successful litigation. All that matters is that it at one time received FDA approval.

Physiomesh may have been compared with the transvaginal mesh when the device received its fast-track approval. The problem lies not only in Physiomesh's malfunctioning but also in its comparison to another faulty medical device. The Ethicon transvaginal mesh is one of the most heavily litigated medical devices and one of the greatest medical device failures in history. How many other medical devices are on the brink of failure given the FDA's faulty fast-track approval logic?

The Ethicon Transvaginal mesh is used to support a woman urinary tract in patients suffering from pelvic organ prolapse a.k.a. urinary incontinence. Like Physiomesh, the transvaginal mesh was intended to be a permanent support for a woman's bladder. Respected internet medical website cites a 2011 report to the US Food and Drug Administration when it listed the serious side effects the device has been reported to have caused including, the device protruding com the soft tissue it was intended to support, painful intercourse, infection and bleeding. In addition, the device rarely prevented a woman's urinary leaking when coughing, laughing or exercising. Consumer highlighted the side effects of the transvaginal mesh as pain, bleeding, bruising, erosion through the vaginal wall, organ perforation, painful intercourses, and vaginal scarring.

Like the transvaginal mesh, Physiomesh was removed from the market following an unusually high number of revision surgeries were required to remove the failed device and to repair a hernia a second time. The National Institute of health has shown that polypropylene, the main component of Physiomesh and the transvaginal mesh is likely to decompose when placed within the human body. As a result of being attacked by the body's immune system, Physiomesh shrinks and painfully pulls away from atop of a hernia that it was intended to support. The device crumpled and often breaks into pieces and travels to other parts of the abdominal cavity where it can perforate any vital organ it comes into contact with. Patients suffering from having to undergo revision surgery for what is considered routine hernia surgery, are encouraged to speak with a knowledgeable Physiomesh hernia attorney to determine if they qualify to file a claim against Ethicon and their parent company Johnson & Johnson for rushing the faulty medical device to market without adequately testing it first.

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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.