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The US National Institute of Health's Physiomesh Polypropylene Warning

Ethicon and Johnson & Johnson ignored warnings from the US National Institute of Health stating polypropylene does not belong within the human body

Monday, July 30, 2018 - In an attempt to capture a share of the billion-dollar hernia repair market, Ethicon introduced Physiomesh to surgeons in the US. Given the high number of revision surgeries that Physiomesh patients have required Johnson & Johnson may have rushed the device to market without adequate pre-market testing. The FDA approved Physiomesh based on its 501 (c) fast-track program which permits sales in the US if the manufacturer can prove that the medical device is substantially similar to other devices that have already been approved.

Unfortunately for Ethicon Physiomesh patients who are suffering from the pain that Physiomesh causes, more should have been done to analyze the polypropylene (plastic) component of the device before giving the device its approval. The US Institute of Health recently concluded that polypropylene degrades when placed inside animals including human beings. The studies concluded, "It was found that polypropylene mesh, ADSC-fixed polypropylene mesh all had different degrees of corrosion and adhesion, but polypropylene mesh was more corroded."

The US National Institute of Health's Polypropylene Warning

Polypropylene is used primarily in food packaging such as single-use plastic bags as well as in straws, plastic condiment containers, and pill and liquid medicine bottles. Polypropylene is in demand as an industrial packaging product due to its ability to withstand high temperatures as well as its strength and flexibility. Ethicon defends the usage of polypropylene in its hernia repair mesh device based on scientific studies of the material published by the US National Institute of Health (NIH). While the study reflects the strength and flexibility of polypropylene to repair hernias that were previously thought of as unrepairable, the study goes on to warn of polypropylene's deficiencies that have led to its failure and the need for the revision surgeries. The NIH abstract states: "The long-term consequences of implantable polypropylene prosthetics are not without concern. The body generates an intense inflammatory response to the prosthetic that results in scar plate formation, increased stiffness of the abdominal wall, and shrinkage of the biomaterial. Reducing the density of polypropylene and creating a ''lightweight'' mesh theoretically induces a less foreign-body response, results in improved abdominal wall compliance, causes less contraction or shrinkage of the mesh, and allows for better tissue incorporation. A review of the laboratory data and short-term clinical follow-up is reviewed to provide a strong basis or argument for the use of ''lightweight'' prosthetics in hernia surgery." (1)

Ethicon Physiomesh patients that have suffered through painful and dangerous hernia revision surgery may consider speaking with an attorney to see if they qualify to file a Physiomesh hernia lawsuit against the company for reimbursement of their expenses and loss of income as well as their pain and suffering. The polypropylene component of Physiomesh has been shown to degrade and shrink and buckle causing the hernia to require revision surgery.

Source: (1)

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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.