Over
130,000 Americans received a DePuy Pinnacle metal-on-metal hip implant between
the years of 2005 and 2010. Although its counterpart, the DePuy ASR XL hip
replacement system was recalled in 2009, the Pinnacle, while employing the same
construction methods and materials, has not been recalled. Because of the
recall of the ASR, there is mounting concern that the Pinnacle may also expose
recipients to the dangers of metallosis or metal toxicity. The U.S. Drug
Watchdog has stated their goal of reaching each and every one of the recipients
of the Pinnacle implant to ensure none who have suffered harm are left behind.
Although
only about a thousand people have come forward to date, the U.S. Drug Watchdog
believes those numbers will grow rapidly, reaching well over 100,000. When the
victims are properly identified they will then be provided access to the most
knowledgeable attorneys who possess a thorough background in the intricacies of
the metal hip implant. The objective of the U.S. Drug Watchdog is to ensure
every person who had their health harmed because of a metal-on-metal hip
implant receives appropriate compensation for failure of the implant.
Metal Hip Implant Hazards
The
DePuy metal-on-metal hip implant system implements a metal femoral head and
metal acetabular cup, both constructed of cobalt and chromium. While most metal
hip implants of this type are expected to last a minimum of fifteen years, the
New York Times reported last December on the extremely high failure rate of the
Pinnacle. In many cases the metal hip implants are exhibiting signs of failure
within mere months of the original surgery. During physical activity the
femoral head and cup rub against one another leading to microscopic metal ions
shaving off and entering surrounding tissues or even the blood stream. Should
the small metal ions imbed into surrounding tissue they can lead to tissue
damage, extreme inflammation, tumors, severe and chronic pain in the groin and
back and elevated levels of toxic metals in the bloodstream. The toxic metals
in the bloodstream can lead to kidney and liver disease as well as certain
types of cancer.
The U.S. Drug Watchdog Questions
Officials
with The U.S. Drug Watchdog have questioned the necessity of the FDA based on
the fact that thousands of Americans have had a metal-on-metal hip implant
despite studies showing the implants had a high failure rate and could expose
recipients to toxic levels of chromium and cobalt. The question appears valid
when you consider the many innocent victims who are facing a lifetime of health
concerns due to a medical device which slid right through FDA approval under
the 510(k) process which requires neither human testing nor clinical trials. It
is hoped that all victims can be identified by the U.S. Drug Watchdog in an
effort to help them.