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Physiomesh Failure Started at the FDA

Medical Devices Such As The Ethicon Physiomesh Were Brought To Market Using The FDA's Flawed, Outdated 501 (K) Fast Track Approval Procedure

Monday, August 13, 2018 - Dr. David Kessler was appointed by President Bush as the chairman of the food and drug administration (FDA) and considers the agency to be "the most important consumer protection agency in the world". According to Dr. Kessler, "Americans rightfully expect public health decisions to be made in their best interest, and to be based on the best science and medicine." (Netflix documentary "The Bleeding Edge")

It was the original charter of the medical devices branch of the FDA to require all medical devices to go through a process called pre-market approval (PMA), a regiment of human testing of medical devices the results of which must be approved by a panel of FDA scientists before a medical device can be offered to the public. As medical technology progressed and medical devices flooded the market the PMA process became untenable. In order to speed up approval, the FDA created the 501 (k) fast-track approval process. Under the 501 process, a medical device can bypass PMA if the manufacturer can show that the new device is substantially similar to one already approved and on the market, even if the device was itself fast-tracked, to begin with. In addition, a device can pass the fast-track process by being similar to a device that has malfunctioned and taken off the market. The only criteria are that the device was once approved. According to Dr. Kessler "the 501 process was designed to be the exception, not the rule." Today approximately 98% of all medical devices seeking approval bypass PMA by using the 501K fast-track process.

What has resulted is that medical devices such as Ethicon Physiomesh may have been approved by being similar to the company's other mesh devices, the transvaginal mesh which, has proven to be an abject failure and cost tens of thousands of women immeasurable pain and suffering. Ethicon and its Parent company Johnson and Johnson voluntarily withdrew Physiomesh due to an exceptionally high failure rate requiring revision surgeries. Surgeons performing revision surgery are now required to preserve Physiomesh as evidence to demonstrate the device's deterioration. Expert's site the body's rejection of Physiomesh's polypropylene component as the root cause of the device's failure, similar to that of the Transvaginal mesh.

Hernia repair patients suffering from the symptoms requiring revision surgery can consult with an experienced and knowledgeable Physiomesh attorney to see if they qualify to seek compensation for their medical expenses, lost wages, and pain and suffering. Physiomesh patients are holding Ethicon and Johnson and Johnson accountable for their negligence in rushing a faulty medical device to market without sufficient human test.

The FDA needs to do more to crack down on medical device manufacturers like Ethicon and Johnson & Johnson that abuse the 501 (k) fast-track approval process given the higher than expected rate of failure of Physiomesh and other medical devices.

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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.