On the US market since the 1990’s, the largely successful Zimmerman NexGen knee replacements have recently come under fire amidst complaints that the latest knee replacements have become prematurely loose. The loosening of the NexGen Flex-CR knee replacement, which is designed to last up to 15 years and connects to the thighbone through natural in growth rather than an epoxy, is beginning to cause many of its recipients so much pain that even the straightening of the knee is painful. Those who have received these faulty replacements are starting to file Zimmer Knee Replacement Lawsuits.
There are those; however who scrutinize the United States Food and Drug Administration (FDA) for allowing the Zimmerman NexGen Flex-CR onto the market in the first place. The NexGen Flex-CR was able to get FDA approval through the 510(k) approval process which 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.
By the FDA claims this system allows companies to innovate and bring new products to market without having to deal with burdensome overregulation. Currently this is only one of the concerns the FDA is currently dealing with. There have been other concerns raised coming from 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.
Many medical device companies are placing their products onto the market without sufficient, if any, pre-market testing, makes one wonder why the FDA is not more involved with monitoring these devices. Over 21 million Americans suffer from osteoarthritis of the knee and the only corrective procedure would be knee replacement surgery, and with the lapse in monitoring on the FDA’s part, the health of millions could be dangerously at risk.
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