The FDA Failed to Adequately Test The DePuy Knee Replacement Device

Medical Devices like the DePuy Knee replacement may not have made it to the market had it not been for an FDA loophole called the 510 (k) fast-track approval process

Monday, November 26, 2018 - Given the high number of DePuy Knee replacement patients needing revision surgery the question of how thoroughly the device was FDA pre-market tested has come to the public's attention. Did the DePuy artificial knee device undergo the rigors of human testing and the review by a critical panel of non-biased government experts or was the medical device rushed to market solely on its economic merits? The latter appears to be the case as the DePuy knee replacement device received 510 (k) "Fast-Track" FDA premarket notification on December 12, 2010, a mere five months from its application. The 510 (k) approval process bypasses the scrutiny and potentially costly delays of regular FDA testing and rushes a medical device to market if company lawyers and scientists can make a case that the device is substantially similar to one that is already on the market. According to the FDA "Section 510(k) of the Food, Drug, and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of three classification categories."

The FDA approval fast-track approach to medical device approval has come under the scrutiny of medical experts and former government officials. Doctors rely on FDA approval of a medical device as the basis of their using the device as a surgical solution for a patient's condition. Surgeons are not in the medical device inspection business as is the FDA. According to the documentary film "The Bleeding Edge," orthopedic surgeons were shocked when they were told that in 2018, upwards of 98% of all medical devices are rushed to market using the fast track system and not subject to premarket human tests. The fast-track system was originally intended to be the exception but has now become the rule. A July 29, 2018 article on www.forbes.com called the FDA documentary "A Scathing Indictment Of FDA's Regulation Of Medical Devices." The article quotes William Kessler, the FDA Commissioner from 1990-1997 as saying "The problem we have is that when it comes to medical devices we built a system that doesn't work."

As a result of inadequate FDA testing many ineffective and dangerous medical devices like the DePuy Artificial knee have found their way to the market. As is often the case with this faulty approval system, the DePuy Knee replacement has proven to be a faulty device that should never have come to market in the first place. DePuy has used the pain and suffering of thousands of individuals as "human test data" to create a new and completely redesigned model called the DePuy Revision Knee Replacement System. DePuy knee recalls for particular DePuy knee components, including the meniscal bearing insert in the LCS knee system and the LPS Lower Extremity Dovetail component are some of the faulty side effects reported.

The FDA Failed to Adequately Test The DePuy Knee Replacement Device

Medical Devices like the DePuy Knee replacement may not have made it to the market had it not been for an FDA loophole called the 510 (k) fast-track approval process

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