In a recent turn of events, consumer rights activists have blamed the U.S. Food and Drug Administration (FDA) for the introduction of several dangerous medical devices. Subsequently, these current FDA regulations have played a significant role in allowing dangerous metal-on-metal hip replacement systems to be sold to unsuspecting consumers. As a result, criticism regarding the current regulations for these devices, or lack thereof, has reached an all time high.
Of particular concern to consumer rights activists, is the current approval process for several metal-on-metal hip replacement systems. One activist group, Consumer Reports, has suggested that the current regulatory policies are not strict enough and therefore warrant revision. However, increased scrutiny has forced the FDA to take matters into their own hands. The agency says it will hold a two-day meeting, beginning June 27, to consider whether more rigorous testing standards are needed.
According to a recent Consumer Union report, there are several medical devices that have been given approval by the FDA without having been the subject of rigorous testing. The report acknowledges that manufacturers often are required to do nothing more than file paperwork and pay a user fee before bringing their products to market.
Consumer Reports emphasizes the fact that several devices, over recent years, have exhibited significant problems and demonstrated a propensity for failure. According to their recent report, metal-on-metal hip replacement systems are among those generating significant concern. These devices have become synonymous with failure and the development of severe complications.
The wear and tear generated by metallic components may lead to significant deterioration over a seemingly short period of time. This degeneration has a tendency to create minute metal shavings that have the potential to cause significant damage to an individual. As a result, these metal pieces may lead to the development of metallosis. Metallosis witnesses the leeching of hazardous metal shards into the fluid of surrounding tissue. The resulting damage may lead to severe pain and even the death of localized tissue.
Metal-on-metal hip replacement systems were given approval by the FDA’s 510K provision without having to partake in safety tests. A practice such as this has proven to be flawed, and in doing so, placed millions of consumers in harms way. According to activists, this 510K provision as the culprit for allowing these dangerous devices on the market.
“510K” refers to the Medical Device Amendment (MDA) of 1976 statutory provision from which FDA granted itself the authority to make exceptions for post-1976 medical devices that the Agency deemed “substantially equivalent” to older products. Essentially, the process works like this: if a manufacturer wants to market a new medical device that falls into a category FDA deems is of “low risk” (e.g., surgical mesh), that product can be marketed without the usual pre-market testing and without formal FDA approval so long as the manufacturer can show that the device is relatively close in design and intended use to a product that is already being marketed. That is so, even if the “old” product was itself never tested or approved by FDA.
What’s worse is that, as it happened, the vast majority of products introduced to the market since 1976 have fallen into this 510K “loophole,” so that most medical devices sold today have never been tested in compliance with the pre-market testing requirements of the MDA, nor have they been formally “approved” by FDA. As such, this lack of strict regulations has allowed dangerous devices to be placed into the U.S. market.
In response to the growing concern over metal-on-metal hip replacement systems, the FDA says it will hold a two-day meeting beginning June 27 to consider whether more rigorous testing standards are needed. The results of the meeting will have an overwhelming affect on the future of these devices and how they are regulated.
Do I Have a Defective Hip Replacement Lawsuit?
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