June 26, 2012 — The U.S. Food and Drug Administration (FDA) will begin a two-day meeting tomorrow regarding the safety of metal-on-metal hip implants. More than 500,000 Americans have already been implanted with the devices, although their popularity is declining as scientific evidence accumulates linking the products to severe side effects. The FDA must now decide what to do about a medical device that was expected to be superior to existing devices, but could actually be more dangerous.
If the FDA decides to require manufacturers to conduct safety studies, it could take up to eight years before they have clear evidence regarding the risks, benefits, safety, and effectiveness of metal-on-metal hip implants. Unlike most other countries, the U.S. government does not have a system for tracking side effects of medical devices. The manufacturers also do not keep track of these side effects.
The FDA is currently attempting to collect data from around the world to determine which patients may have the highest risk of side effects from the hip implants. In the FDA meeting later this week, experts will discuss best practices for monitoring current patients with the devices.
It is possible that the FDA panel will recommend blood tests, routine imaging, or laboratory tests. British health regulators have already recommended routine blood tests to check for dangerous levels of metals in the bloodstream. Some British researchers are calling for an outright ban of the devices, saying that the risks outweigh the benefits when compared to plastic and ceramic hip implants. These researchers found that 6% of metal-on-metal devices failed within the first five years — triple the 2% failure rate of plastic and ceramic devices.
The metal-on-metal hip implants were fast-tracked through the 510(k) loophole in the FDA’s approval process, which allows “similar” devices to be approved without conducting well-controlled safety studies. Since the metal-on-metal design was “similar” to plastic and ceramic hip replacements on the market since the 1950s, manufacturers were allowed to sell the products without conducting safety studies.
The manufacturers claimed that the metal-on-metal design would last longer than other devices, making it ideal for younger, physically active hip implant recipients.
Unfortunately, after hundreds of thousands of people were implanted with the devices, researchers noted some severe side effects that were unique to the metal-on-metal design. The metal parts grinding together could shed toxic ionic particles of chromium and cobalt into the person’s bloodstream and surrounding tissue, causing metal poisoning (metallosis or cobalt poisoning). Studies also linked the metal-on-metal design to higher rates of pain, swelling, corrosion, pseudotumors, bone loss, and tissue damage.
Do I have a Metal-on-Metal Hip Implant Lawsuit?
The Schmidt Firm, PLLC is currently accepting metal-on-metal hip implant induced injury cases in all 50 states. If you or somebody you know has been injured by a metal-on-metal hip implant, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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