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Ethicon Pulls Physiomesh From the US Market

Ethicon will not admit the exact reason so many Physiomesh patients require additional surgery

Monday, May 21, 2018 - Doctors performing hernia repair surgery had used Physiomesh during laparoscopic surgery. During laparoscopy surgery for hernias is performed by creating a one-centimeter incision and inserting a camera and miniature surgical equipment into the abdomen. The procedure is preferred as there is no need for a large incision as in traditional surgery. Physiomesh is placed over the location of a hernia and polypropylene fibers create the necessary inflammation to cause scar tissue to develop, partially absorbing the mesh and holding it in place.

Ethicon Physiomesh, once thought of as a breakthrough medical device, is now known to cause more adverse side effects than was originally anticipated. Physiomesh lists adverse reactions on its website as "those typically associated with surgically implantable materials, including infection, inflammation, pain, adhesion formation, fistula formation, and extrusion." What is not mentioned is that when the Physiomesh Composite Hernia Mesh fails to adhere to a hernia it was intended to repair it can migrate to other organs, the intestines in particular, and block or perforate them. This can cause intestinal blockages, nausea and vomiting, and infections which may require surgery. In addition, revision surgery will be needed not only to repair an original hernia but also to locate Physiomesh, remove it, and also remove the tissue and internal organs it has damaged. Even when Physiomesh remains in place as it was intended, it may weaken resulting in an original hernia breaking through. By that time the device may have become so encased in scar tissue that it is impossible to remove without removing a major portion of the herniated abdomen with it.

As a result of the high number of necessary revision surgeries the US food and drug administration urged Ethicon to initiate a voluntary market withdrawal of Physiomesh to which the company immediately complied by issuing an "Urgent Field Safety Notice." The alert was sent to all medical personnel, operating room staff and chiefs of surgery stating in no uncertain terms:

EFFECTIVE IMMEDIATELY -- DO NOT USE OR DISTRIBUTE Ethicon® PHYSIOMESH®

Patients suffering from the pain caused by a defective Physiomesh device that required a revision surgery are hiring a Physiomesh attorney and filing a claim against Ethicon and their parent company Johnson and Johnson for rushing a faulty product to market. Rather than perform the FDA's battery of stringent pre-market testing, Ethicon chose to take advantage of the FDA's 501(k) "fast track" process. A product can bypass the significant cost and delays of field testing if the company can show that the product is substantially similar to others that are already approved and on the market.

While Ethicon has said that they cannot pinpoint the exact reason Physiomesh does not work as intended, a voluntary market withdrawal indicates the company may know there is a problem. Changes to the device's material may cause it to contract, buckle, and pull away from the point of a hernia leading to the need for a painful, dangerous, and expensive revision surgery. Hernia mesh lawsuits may ultimately uncover much more new information.

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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.