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The FDA Should Take Another Look At Their Hernia Mesh Classification

Reports of patients requiring multiple, dangerous surgeries to attempt to retrieve sections of hernia mesh should alert health officials that hernia mesh is more dangerous than they originally thought

Monday, October 7, 2019 - Hernia mesh implants have been rushed to market without sufficient testing, having been approved mainly via the FDA's flawed 510 (k) approval process where a company is only required to prove that the device is substantially similar to one that has already been approved. The FDA's system fails to take into consideration whether or not the previous device has failed, been recalled, or the subject of multiple lawsuits. The 510 (k) fast-track bypasses the rigorous and time-consuming clinical trials and human testing which is postponed and left to the aftermarket. Companies that use the fast-track process to speed their product to market are required to monitor their patients, post-hernia mesh implants, and the results and experiences are to report back to the FDA. The problem with this system is that it often takes years to gather the data of patient experiences and pass them back to the FDA in which time millions of people can suffer and even die. Also, many hernia complaints go unreported as most doctors will not admit that hernia mesh failure could be the cause of their patient's pain and suffering for obvious legal reasons. Physiomesh hernia lawsuits are experienced products liability litigators and pursuing justice on behalf of American families harmed by Ethicon hernia mesh.

The FDA may not be able to keep up with the sheer volume of medical devices that come to market, everything from artificial hearts to the smallest paper clip and rely on the 510 (k) fast-track system. The FDA does not have the time or resources to test every new medical device and relies on the previous testing of similar devices. As a result, many substandard medical devices slip through the crack and a 510 (k)- approved device is 10 times more likely to be recalled than one that was subject to scrutiny. Hernia mesh has been incorrectly classified, in my opinion, as a Class II medical device by the FDA. Class II medical devices have a moderate to high risk to the user, and half of all medical devices fall under this category. When hernia repair mesh dissolves into multiple pieces and migrates throughout the body, it makes it impossible to retrieve without multiple major surgeries. That alone should cause the FDA to elevate it to a Class III medical device, one where the device itself could cause bodily injury or death.

If the FDA ever decides to reevaluate the status of hernia repair mesh it needs to look to Europe where health authorities think that around one in every three hernia repair mesh patients will require at least one additional surgery. From a post-market review perspective, Johnson & Johnson voluntarily withdrew their Physiomesh Composite hernia repair mesh from the market worldwide when they received the data that their mesh failed in so many of their patients requiring revision surgeries.

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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. OnderLaw 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. OnderLaw 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.