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Polypropylene Could be The Cause of Physiomesh Failure

Physiomesh is not the only mesh repair product made from Polypropylene that had to be recalled due to unforeseen complications

Thursday, May 24, 2018 - When the FDA receives an unusually large number of complaints that a particular make of medical device is causing unforeseen side effects, one of the first thing they do is to notify the manufacturer that there is a problem. That is exactly what has happened and Ethicon immediately and voluntarily pulled its hernia mesh product, Physiomesh from the global market rather than try to defend their hernia repair product. Ethicon, a subsidiary of Johnson & Johnson, issued an Urgent Field Safety Notification to all administrative, medical, and surgical personnel in the United States, urging them to cease and desist using all batches of Physiomesh. Physiomesh is a flexible composite mesh used during minimally invasive hernia repair laparoscopic surgery.

Physiomesh is not the first mesh repair product that has been found to be problematic for Ethicon's patients. Years earlier, Ethicon along with a host of other companies, was forced to recall its gynecological mesh that had already been implanted in more than 2 million women. Over 100,000 women filed suit against a range of mesh manufacturers including a large number against Ethicon. According to CBS news "the lawsuits were gathered in what turned out to be the largest multi-district litigation since asbestos." Plaintiffs suing a host of companies including Ethicon were awarded billions of dollars in compensation for medical expenses, lost wages, pain, and suffering as well as considerable punitive damages to hold companies responsible for their negligence. Ethicon Physiomesh problems come with a multitude of side effects warnings for patients implanted with the hernia mesh.

At the core of the findings against gynecological mesh products was its Polypropylene composition, the same material used in Ethicon's Pyhsiomesh. Plastics experts have testified that Polypropylene is unstable and its intended use is for packaging, not for implantation in the human body where is shrinks, buckles and disintegrates into multiple pieces. Doctors have had to remove thousands of transvaginal meshes and have testified that the device disintegrates, shrinks and breaks into pieces. As a result, pieces of Physiomesh can migrate to other parts of the body causing organ damage and intestinal blockages. Other unexpected side effects caused by Physiomesh include allergic and autoimmune reactions as well as constant pain.

It is suspected that Johnson & Johnson may have used its considerable influence and clout to rush Physiomesh to market and sidestep the costs and delays of human testing normally required by the FDA for other medical devices. The company was able to convince government regulators that Physiomesh was substantially similar to other hernia repair mesh products on the market and its approval was fast-tracked using the 501 (k) process. Thousands of reports made to the FDA and European studies indicate that an unacceptably high number of Physiomesh patients have had to have revision surgery to try and locate and then remove the device, and then repair an original hernia using traditional methods. If you or a loved one have had hernia mesh surgery you should consult a Physiomesh attorney to seek the compensation you deserve.

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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.