Martes, Hunyo 11, 2013

F.D.A.'s New Rules for Metal-On-Metal Hip Implant Makers

Studies have shown that people who have had metal-on-metal hip devices implanted are at risk for complications and may experience harm compared to conventional hip replacement devices made of plastic or ceramic.  In fact, according to legal experts, almost all hip replacement lawsuits have stemmed from using metal-on-metal hip replacement devices. It is expected that a lot of people will continue to file lawsuits for the side effects and complications they have experienced in using such products.

Reasons Why Metal-On-Metal Hip Replacement Devices Fail

Not all hip replacement devices fail. Actually, some of them work fairly well, designed for years of use without any adverse effect experienced by the patient.  However, some medical experts also note that there are times when some components of the device can be subjected to wear and tear, producing metal shedding that travels up into the system.  These metal components are usually being excreted from the body through urine.  The problem only occurs when these components aggregate in the hip joints.  This may cause an adverse reaction in the tissues surrounding the implant, as well as premature hip implant failure.  In worse cases, this may bring about significant damage to tissues and even lead to complications in the nerves, bones, muscles, and tendons leaving the patients even more disabled.

F.D.A. Becoming Strict with the Regulation of Metal-On-Metal Hip Implants

According to online news reports, due to many cases of premature hip implant failures in the U.S., the FDA is setting regulations that could inhibit manufacturers from merchandising defective implants.  Makers of metal-on-metal hip implants have to show that their devices are effective and safe before they could acquire consent or authorization to continue selling their existing products or obtain validation for their new metal-on-metal hip prosthetic designs. This means that the manufacturers have to present clinical data for safety and efficacy.

In the past, manufacturers only have to meet one requirement in order for them to gain approval to legally market a certain product.  This primarily involves demonstrating to the federal agency that the new device possesses a similar design to those already on the market.  The process, on the other hand, does not require manufacturers to conduct regulated testing prior to releasing the product to the public. The new rules being set by the FDA may not only help the consumers but also the manufacturers. This may save people from experiencing dangerous side effects and at the same time lessen the lawsuits against the manufacturers of hip replacement devices. More updated news and articles regarding hip implant lawsuits can be found on personal injury law firm sites like the Rottenstein Law Group’s

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