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The Problem With The FDA's 501 (k) Fast-Track Approval Process Is That It Bypasses The Testing Usually Required Of A New Medical Device

Doctors that recommend the device to patients assume that rigorous pre-market testing has occurred however 99% of the time a new device like the Physiomesh Composite hernia device is not tested at all

Tuesday, September 18, 2018 - All a medical device like Physiomesh has to do is to demonstrate to an FDA panel that the new medical device is substantially similar to one already approved. It is irrelevant to the approval process whether or not the device the new one is compared to has failed and been taken off of the market. All that matters in this flawed FDA approval process is that the device was once approved. As a result, faulty medical devices like the failed and recalled Physiomesh make their way to consumers, fail and injure consumers, and after a period of years are pulled from the market. All the while, medical device companies make millions before public outcry forces the device off the market.

That may be what has happened in the case of Physiomesh. In May of 2016, Ethicon and Johnson & Johnson, responded to complaints and voluntarily and permanently withdrew Physiomesh from the market worldwide after years of making substantial profits. An abnormally high number of complaints were coming into European health watchdog Herniamed, claiming that Physiomesh had degraded within patient's bodies causing it to shrink, buckle, and painfully pull away from atop of a hernia that it was intended to support. Upon revision surgery, doctors found that Physiomesh migrated to the small intestines and perforated them causing life-threatening obstructions. Doctors also report that the original hernias have reoccurred and had to be repaired all over again.

Thousands of Physiomesh patients have hired Physiomesh lawyers and filed claims against Ethicon and their parent company Johnson & Johnson alleging that the company rushed a faulty medical device to market. Many point out that Physiomesh failure actually started at the FDA due to their flawed, outdated 501 (K) fast-track approval procedure. Former FDA chairman Dr. David Kessler has been quoted as saying that he considers the FDA, "the most important consumer protection agency in the world, (and that) Americans rightfully expect public health decisions to be made in their best interest, and to be based on the best science and medicine."

Medical devices were once required by the FDA to undergo human testing. FDA scientists and experts reviewed the results. A medical device could be offered to the public only upon their approval. The 501 (k) fast-track approval process was born when the proliferation of medical devices made premarket testing unworkable. According to Dr. Kessler "the 501 processes were 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." It has been speculated that Ethicon used its other failed mesh device, the transvaginal mesh, for comparison purposed in order to get Physiomesh quickly on the market.

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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.