Physiomesh Substantially Similar to Other Failed Medical Devices

The FDA's fast-track approval process allows dangerous medical devices like Physiomesh on the market

Monday, October 1, 2018 - Johnson & Johnson subsidiary Ethicon Inc. permanently withdrew Physiomesh, the world's leading hernia repair device, from the market worldwide due to an abnormal number of complaints. Complaints were varied and included the hernia repair mesh shrinking, crumbling, buckling, and pulling the sutures from the tissue surrounding the surgically-repaired hernia it was intended to support. The hernia mesh is then free to migrate to other areas in the abdominal cavity and usually winds up down in the lower intestines where it can create dangerous blockages. Over 1200 individuals who have suffered from having to a second surgery to remove the failed medical device have hired a Physiomesh attorney and are suing Ethicon and their parent company, health-care conglomerate Johnson & Johnson. Plaintiffs claim that the company rushed a faulty, inadequately tested medical device to market without first performing human tests. Ethicon took advantage of the FDA's 501 (k) fast-track approval process to rush Physiomesh to market. The fast-track program permits faulty, life-threatening medical devices on the market quickly and without pre-market human testing and is now coming under increased criticism.

The FDA's 501 (k) fast-track approval process was originally intended to be an exception and not the rule. Today, "over 98% of all medical device approvals are as a result of the FDA's fast-track process," according to former FDA chairman Dr. David Kestler. In addition to permitting the device to be sold too quickly, the fast-track program allows a medical device to be compared with a previously approved medical device without taking into consideration whether or not the device worked as intended, was the subject to a high number of lawsuits, or whether or not the device itself had been recalled or withdrawn. Physiomesh was likely compared to another Johnson & Johnson mesh product, the transvaginal mesh, which failed, was recalled, and cost Johnson & Johnson hundreds of millions of dollars in legal fees and punitive jury awards. What we do know for sure is that Physiomesh is "substantially similar" to the transvaginal mesh in the high number of the implanted devices that have caused pain and suffering, have failed, and have had to be removed. Not only that, but the transvaginal mesh could have also been linked to another failed mesh, and that mesh to another in a fashion called a "daisy-chain." The movie documentary "The Bleeding Edge" claims that it would not be unusual for a medical device to be daisy chained to ten or more failed medical device, all of which escaped the rigors of FDA monitored human pre-market testing.

Like its predecessor, the transvaginal mesh, Physiomesh uses Polypropylene as its core component. Polypropylene is used extensively for its strength, flexibility, and durability, however, clinical testing has shown that the material breaks down and degrades when placed inside the human body. The National Institute of Health has conducted a study that indicates polypropylene may not be a suitable material for medical devices since polypropylene corrodes quickly when placed inside test animals. According to the study "New Zealand White female breeder rabbits were implanted with polypropylene mesh, ADSC-fixed polypropylene mesh in the abdomen. After 4 weeks, adhesion was performed and the erosion of the mesh was evaluated. It was found that polypropylene mesh, ADSC-fixed polypropylene mesh all had different degrees of corrosion and adhesion, but polypropylene mesh was more corroded."

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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.

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Physiomesh Substantially Similar to Other Failed Medical Devices

The FDA's fast-track approval process allows dangerous medical devices like Physiomesh on the market

More Recent Ethicon Physiomesh Lawsuit News:

Lawyers for Ethicon Physiomesh Lawsuits