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Physiomesh May Have Been Compared With Transvaginal Mesh to Receive FDA Fast-Track Approval

Physiomesh may have been given FDA approval based on its similarities to a device that has failed and pulled from the market

Tuesday, August 14, 2018 - Given the FDA's lax regulations in approving 99% of all medical devices with little if any human testing, it is possible Physiomesh may have been approved for its similarities to Novartis' other mesh device, the Transvaginal mesh.

An unusually high number of hernia repair patients complaining of being in more pain after having their hernia repaired as a result of Ethicon Physiomesh failures have prompted the company to issue an Urgent Field Safety Notice to voluntarily recall Physiomesh from the market. Physiomesh is made from a material called polypropylene, a durable and flexible plastic polymer that is more suited to wrap a sandwich than to be placed inside a person's body. As a foreign and toxic substance, polypropylene immediately triggers the body's natural immune response system causing Physiomesh to decompose and lose its strength. Physiomesh shrinks and pulls painfully away from the hernia site where it was once sutured in place. Surgery is required to remove the foreign matter from the body but often Physiomesh has so liquefied that its full removal is impossible. Fragments of Physiomesh that are left behind usually find their way down to the intestines where it causes painful blockages.

Johnson & Johnson rushed Physiomesh to market under the often abused 501 k approval FDA approval program. It has come to light that over 90% of all medical devices are approved, not by a panel of FDA scientists whose interests are in protecting the public, but by simply showing that the medical device is substantially similar to one that is already on the market. Consideration is given to the similarities between medical devices with no discretion as to whether or not a device malfunctioned and was later recalled; Physiomesh may have been compared with Ethicon's other mesh device, the transvaginal mesh which was used to support a woman's bladder after pregnancy. Johnson & Johnson has spent billions for legal costs to settle claims with wobeen who alleged that the transvaginal mesh failed and left them incontinent.

What is Physiomesh?

According to the medical website, "ETHICON PHYSIOMESH" 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. Because hernias have a high rate of reoccurring Physiomesh was designed to reinforce a hernia surgical site by being placed on top of it, internally within the abdominal wall and sutured in place. Over time, theoretically, scar tissue was intended to form to hold the device in place.

In the end, it appears very possible that Johnson & Johnson was looking to limit their legal costs by voluntarily withdrawing Physiomesh. Physiomesh patients requiring revision surgery are hiring Physiomesh lawyers to file a claim against the device's manufacturer Ethicon and their parent company Johnson & Johnson.

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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.