FDA Oversight Insufficient for Medical Device Patients

FDA Oversight Insufficient for Medical Device Patients

Zimmer first developed the NexGen line of knee replacement systems in 1994 and has largely enjoyed success with product releases. However, there have been some rumblings lately that one of the most recent product releases in the NexGen line is failing prematurely in patients. There have been reports of patients experiencing loosening, pain, or even requiring revision surgery just a few years after receiving the device, which is supposed to last upwards of 15 years. The culprit is the cementless NexGen CR-Flex, which is designed to connect to the thighbone through natural ingrowth rather than an epoxy.

Fingers are being pointed everywhere for the alleged failure of the device, including at the U.S. Food and Drug Administration (FDA). The 510(k) approval process, which is the method through which the NexGen CR-Flex was approved for sale to the public, automatically clears for sale devices that are "substantially similar" to an already approved device. The criticism of this system is that it allows companies to release products to market without adequate pre-market testing.

Though the policy behind such a lack of scrutiny is that it allows companies to innovate and bring new products to market without having to deal with burdensome overregulation. Even if the FDA is given the benefit of the doubt for its reasoning with regard to the approval process, there are other alarming issues with its oversight of the medical device industry. According to a report by the United States Government Accountability Office, the FDA's post-market surveillance of the device industry is insufficient to protect consumers. Additionally, it has not regularly conducted the proper inspections of medical device manufacturing facilities.

Given the ease that companies can bring products to market without conducting pre-market testing, it is inexcusable for the FDA to not sufficiently monitor the industry. Over 21 million people in the United States suffer from osteoarthritis of the knees, which is the condition that typically precedes knee replacement surgery. The health of each and every one of those people is what hangs in the balance.

If you underwent knee replacement surgery with a NexGen CR-Flex knee replacement system and have suffered loosening, pain, or required premature revision surgery, then your circumstances could dictate a successful Zimmer knee lawsuit. The first step in determining whether or not you have a valid claim is to consult with an experienced legal professional. The attorneys at the Rottenstein Law Group have a track record of helping clients get the restitution they deserve spanning a total of over two decades.

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