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Doctors Are Surprised With Lax FDA Approval Requirements

Surgically implanted medical devices have the potential to cause serious injury and death to patients but little is required of them by the US Food and Drug Administration before going to market

Monday, August 27, 2018 - With what we now know about the faulty logic behind the FDA's 501 (k) fast-track medical device approval program, it is almost a certainty that Physiomesh took advantage of the legal loopholes. Ethicon Inc's Physiomesh circumvented pre-market human testing along with the scrutiny of a panel of FDA scientists when the medical device was deemed to be "substantially similar" to other mesh surgical devices already on the market and was granted immediate approval.

Doctors implanting Physiomesh in their patients assumed that rigorous testing had been performed on Physiomesh and that their patients would be safe if they used the mesh screening to reinforce their hernia-repair patients. What they were not aware of is that the device may have only been compared to and deemed similar to the company's other failed polypropylene screen device, the transvaginal mesh, a failed medical device that has been pulled from the market due to thousands of patients suffering and filing multi-million dollar lawsuits. When the same problems started to occur with Physiomesh, Ethicon and Johnson & Johnson decided to voluntarily withdraw Physiomesh from the US market rather than encourage what was sure to be a similar spate of lawsuits. Doctors were surprised when thousands of Physiomesh patients complained of painful side effects from their hernia repair and required revision surgery to remove the decomposed polypropylene Physiomesh. Physicians were also shocked when they were told that the FDA's medical device approval process requires a medical device company to show a mere similarity to another device that at one time was on the market, regardless of whether or not the device has failed and been recalled, and that 98% of all medical device approvals are "fast-tracked" in that fashion.

When Ethicon pulled Physiomesh from the market they failed to give a specific reason for the failure of the device, admitting, however, that there were multifactorial reasons behind Physiomesh's malfunctioning and that product design could be one of those reasons. Studies published by the National Institute of Health point to Physiomesh's polypropylene composition as a potential reason the device is attacked by the body's natural immune response mechanisms and deteriorates, buckles, crumples and pulls free from the intend spot overtop of the repaired hernia. Rather than give support to a surgically repaired hernia, Physiomesh can cause a hernia to re-rupture and require a second surgery. Those who chose to have Physiomesh removed are required to advise their surgeons to save the device and to ship it to a medical storage facility in Florida to be used by both sides as evidence should the patient decide to hire a Physiomesh lawyer and file a claim against Ethicon and its parent company Johnson & Johnson. Physiomesh was taken off of the US market as of May of 2016.

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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.