FDA investigating hip replacement medical device safety

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The Food and Drug Administration (FDA) held a two-day meeting beginning on Wednesday, June 27th to study the safety of metal-on-metal hip replacement medical devices.  The investigation was prompted by thousands of reports of pain, swelling, and replacement of implants. 

For many years, most orthopedic implants, including hip implants, were made of plastic or ceramic.  In the last decade, many surgeons used implants made with metal stems and sockets.  Laboratory tests had indicated that the metal-on-metal implants would wear better, last longer, and be less prone to dislocation. However, recent data amassed by British orthopedic surgeons suggests the opposite is true.

In March 2012, experts at the world’s largest artificial joint data registry instructed surgeons to stop using metal-on-metal medical devices for the reason that they needed to be replaced more frequently than other implants.  While the metal-on-metal implants were marketed as lasting from 10 to 15 years, more than 6 percent of recipients required replacement after less than 5 years.

British experts recommend annual blood tests for individuals with metal-on-metal implants to check for higher than normal concentrations of metals such as cobalt and chromium.  As the metal components of the implants rub against each other, metal particles can slough off into the bloodstream.  Currently, no similar recommendations have been made for American patients.  FDA scientists have stated they will consider all available information and not rely solely on the British data.

Some American orthopedic surgeons have already concluded that better options than metal-on-metal implants exist. Dr. Art Sedrakyan, professor of public health at Weill Cornell Medical College in New York, stated “[i]n my personal opinion there is very little room, if any, for metal-on-metal implants because the alternatives we have on the market are likely safer and as effective.”

Between 2000 and 2011, the FDA received nearly 17,000 adverse event reports concerning metal hip implants.  Experts state that this number is not an accurate indication of the scope of the problem because many doctors do not report problems to the FDA.

To date, an estimated 500,000 Americans have received metal-on-metal hip implants.

For more information on litigation surrounding these medical devices, contact the Ohio hip replacement lawyers at Clark, Perdue & List.

Source: MSNBC “FDA probes safety issues with metal hip replacements,” Matthew Perrone, AP, June 25, 2012.