New hip (Photo credit: okadots)
February 28, 2012
The British Medical Journal reported today that a million or more Americans have had metal on metal orthopedic implants installed since 2003. That number continues to climb as as manufacturers continue to promote metal on metal devices. This, despite the recall of devices (Depuy ASR), growing evidence of exposure to toxic and potentially carcinogenic metal ions, and the unprecedented requirement by the FDA that manufacturers conduct post-marketing studies.
Startling Highlights Contained in the Report Include the Following:
*Failure rates for all metal on metal hip implants is currently 13.6% as opposed to 3.3% for implants made of other materials.
*Multiple studies and research organizations have warned about the carcinogenic potential of metal-on-metal hip implants.
*Internal Depuy memos from July 2005 identify potential immune function changes and carcinogenic concern.
*Because of concerns, Depuy sales representatives were given paper entitled "Setting the record straight on metal hypersensitivity" written by Dr. Thomas Schmalzried (Depuy's hired consultant, stooge, or whatever you want to call him).
*In 2006, based on concerns, the MHRA (Medicines and Healthcare Products Regulatory Agency) committtee concluded that "there is evidence to suggest that some metal-on-metal hip replacements may be associated with increased DNA changes.
*Data showed raised metal ion levels in the Depuy Pinnacle were available since 2008, yet the device was promoted as the alternative for the subsequently recalled Depuy ASR.
*Speaking of the lax regulatory environment, one Depuy product manager responded to an email stating that "you could literally implant a tent rod if you wanted!"
Unfortunately for those with MOM implants, I fear that the news is only going to get worse. The revision rate on our Depuy ASR clients is currently 46% and climbing.
If you have a MOM hip implant, it is imperative that you have regular blood tests for cobalt and chromium.
For additional information, feel free to contact me at Chrish@PittmanDutton.com