DePuy Orthopaedics issued in August 2010 a global recall of
its ASR Hip Resurfacing System and ASR Acetabular System. The action resulted from the data provided by
the National Joint Registry of England and Wales. It showed that 1 in every 8 individuals
(about 12%-13%) whowere implanted with the devices needed revision surgery only
after five years of receiving it. Prior to the issuance of the recall, there
were about 93,000 defective ASR Hip Implants sold and implanted in individuals
in the U.S. and abroad.
The DePuy ASR Hip Implants were sold between 2005 and 2009. An
individual who received the metal-on-metal hip implant within this period, and
is suffering serious complications due to the implant’s failure requiring
corrective surgery, may have been a victim of DePuy ASR Hip Implant. Symptoms
usually occur as follows:
Swelling or pain
in the effected hip or surrounding areas
Difficulty walking
or pain in the hip when doing so
Grinding or
popping noises originating in the hip area
Inflammation or infection in the affected hip
area
Implant loosening
Dislocation of the
implant components
Bone fractures at
the hip
Metal poisoning, akametallosis, resulting from metal debris
shed by device components rubbing each other
Awareness of this recall by those who are not even yet
affected by these problems is necessary. The absence of these symptoms is not
an indication that the implant has not failed or is not affecting the health of
the user. Thus, it is imperative that every individual who have received a
DePuy ASR Hip Implant contact their physician for reevaluation, despite feeling
no problems with the device.
Though recall was issued in 2010, there is apparent reason
for DePuy Orthopaedics to know that its ASR Hip Implant devices pose dangers to
patients years before its recall. In fact, in March 2006, DePuy already wrote
to doctors to alert them of the ASR devices’ higher-than-expected failure rate
with the clarification that this only affects certain patients: women, patients
of short stature, and those with weak bones. Then, come December 2009, units of
ASR were withdrawn from the Australian market and released plans to do so
worldwide in 2010. In DePuy ASR hiplawsuit pre-trials, the company insists that the recall the ASR Hip Implant
in Australian was due to poor sales.
The DePuy ASR hip implant was approved by the U.S. Food &
Drug Administration (FDA) through its 510(k) approval process. This process of
streamlined clearance allowed medical devices such DePuy’s to gain approval
without human clinical trials by showing that the device is “substantially
equivalent” to existing products being distributed in the market. Nonetheless, a
report by the New England Journal of Medicine (NEJM) says that the DePuy ASR’s
approval by the FDA was based on the similarities to existing implants, though
the device has significant changes in material as it used a metal alloy cup
from a different hip device that retrofits to a standard hip implant. This
metal-on-metal design change was thought of as a major innovation despite lack
of test, the NEJM reported.
What are the dangers of a metal-on-metal hip implant?
The DePuy ASR Hip Replacement devices subjected to the recall
of August 2010 are metal-on-metal hip implants.
It is a class of devices that recently have been suspected of serious
complications and injuries. Individuals with metal-on-metal hip implants, these
include the DePuy ASR devices, suffered loss of bone, the demise of surrounding
tissue, the development of pseudo-tumors in the same area, and early failure
that requirescorrective surgery. There is the belief that these complications
are resulted from minutemetal shards being shed by the rubbing metals into the
blood stream. This leads to metallosis
and cobalt poisoning. Come 2011, the rising number of complications reported by
people with metal-on-metal hip implants prompted the FDA to direct DePuy Orthopaedics
and 20 more manufacturers of hip replacement to conduct post-market studies of
their devices to see if the metal shedding result to dangerous amounts of
metallic debris among its users. The
foregoing medical findings, combined with the FDA’s directives and consequent
recall, scores of individuals are now geared towards filing Depuy ASR hip lawsuits.