The failure
rate of the DePuy ASR hip implant system was stated by the company at the time
of the August, 2010 recall as being 12%--high for hip implants under any
circumstances. A 2011 article in PubMed.gov, however, placed the failure rate
of the ASR resurfacing implant at 25% at six years and 48.8% at six years for
the ASR total hip replacement system.
Further, in this particular study, 26.1% of the ASR patients in this particular study had serum cobalt and chromium concentrations greater than 7 parts per billion. A normal person will have 0.5 parts per billion of cobalt and chromium in their bloodstream, occurring naturally, and most doctors consider any levels beyond 5 parts per billion to be excessive.
Further, in this particular study, 26.1% of the ASR patients in this particular study had serum cobalt and chromium concentrations greater than 7 parts per billion. A normal person will have 0.5 parts per billion of cobalt and chromium in their bloodstream, occurring naturally, and most doctors consider any levels beyond 5 parts per billion to be excessive.
When the metal
parts of the ASR rub against one another, metal ions are released which can
become lodged in the surrounding tissues or enter into the bloodstream. Those
that lodge into the hip tissue can cause pain for the implant recipient as
necrosis of the tissues occurs. In some cases ASR recipients will experience
total failure of the hip implant due in part to the manner in which it is
attached. The ASR uses no screws, rather depends on the bone to properly grow
around the implant through its porous surface. As of August, 2012, two years
following the recall, only about 8,000 ASR implant recipients had joined in the
lawsuits against DePuy and Johnson & Johnson. Should the failure rate of
the ASR actually reach the 48.8% estimate, this means that out of the
approximately 45,000 ASR’s implanted in the United States there are potentially
many more which can reasonably be expected to fail or cause serious health
issues in the future.
What this
means for recipients of the ASR who have not yet experienced pain or other
problems from the hip implant is that there is a very good chance they will
have problems in the future. In twenty six states the Statute of Limitations
for lawsuits against defective products is two years. For many, that SOL has
run, yet an attorney may be able to argue that the recipient was unaware of the
recall of the ASR. Those who have been implanted with an ASR could suffer
symptoms of metal toxicity in addition to tissue damage, inflammation and pain.
Excess amounts of cobalt and chromium in the body can lead to neurological,
cardiovascular, renal and thyroid disorders, vision and hearing loss,
gastrointestinal issues, skin disorders, balance disturbances, and mood
disorders such as anxiety, irritability and depression.
Whether you
have yet experienced pain or other problems as a result of your ASR hip
implant, it is important that you receive medical and legal advice. You will
want to speak with your physician and have blood work done to determine the
levels of cobalt and chromium in your body, and will likely also have a bone
scan, x-rays and MRI to check for inflammation, bone loss and tissue
degradation. Your attorney will look at the facts and circumstances surrounding
your ASR hip implant as well as your current state of health in order to
determine whether you are eligible to file a lawsuit against DePuy and its
parent company, Johnson & Johnson.
No comments:
Post a Comment