The DePuy ASR
metal-on-metal hip implant has repeatedly made the news following a voluntary
recall on August 26, 2010. While DePuy’s Pinnacle metal hip implant has not
suffered under the recall stigma, many feel that it offers the same risks to
implant recipients as the ASR. And, in fact, many attorneys are constantly
asked by their clients about the differences between the ASR and the Pinnacle.
The primary distinction between the two metal hip devices lies in the fact that
the Pinnacle uses an insert liner between the acetabular cup and the femoral
head while the ASR does not. It has been theorized that the ASR cup was too
shallow for the head, leading to the ball hitting the edge of the cup and metal
shavings to shear off into the body, also know as edge-loading.
While the Pinnacle’s cup
was designed to give greater depth and allow the femoral head to move more
freely within the socket, in some cases it still has been know to cause
metallosis in implant recipients when the cobalt and chromium ions migrate
around the body. Metal poisoning can cause a wide variety of adverse medical
events. Many ASR recipients have had cardiovascular, renal, neurological and
thyroid issues although studies done in the 70’s do not definitively tie these
metals to cancer. Unfortunately, due to the lack of comprehensive studies on
safe levels of cobalt and chromium in the body and the effects of toxic levels,
nobody really knows just how dangerous these metals can be should they migrate
to the bloodstream. The metal shards can also lodge into the surrounding
tissues causing degeneration and destruction.
Many people who are not
even fully aware of the negative health risks that they have been exposed to
are shocked when their surgeon opens them up only to find grey and brown dead
tissue surrounding the hip implant. This is a serious medical problem because
muscle does not regenerate. Although the surrounding muscle tissue can be made
stronger, once tissue is gone, it’s gone for good. By DePuy’s own estimates one
in every eight ASR metal hip recipients will experience extreme levels of pain,
immobility and the necessity of a revision surgery. Some experts believe the
number of ASR patients who will require a revision surgery at some point is
closer to 50%, and, in and of themselves, the revision surgeries have been
known to cause serious and permanent disabilities. The Pinnacle has not been recalled and there are
presently over 150,000 recipients of the metal device in the United States
alone. Experts who have tracked recipients of both metal implants believe that
at least ten percent of Pinnacle
metal implants will fail within the next several years.
Both DePuy and Johnson and
Johnson (the parent company of DePuy) continue to forcefully deny any risk to
recipients of the Pinnacle metal-on-metal implant. In fact, DePuy states that
the Pinnacle metal hip implant is absolutely the best metal implant currently on
the market and that it performs as well or better than all other metal-on-metal
replacement hips. Because of these strong beliefs, the company is not rushing
to settle the rash of lawsuits alleging problems with the Pinnacle. Perhaps one reason DePuy is fighting so hard
to protect their Pinnacle line is that it encompasses not only the
metal-on-metal hip implant but the metal-on-polyethylene and metal-on-ceramic
implants as well. A recall or settlement of the suits already filed would
definitely cast a shadow on the other Pinnacle products in the line.
Although doctors began
monitoring their ASR patients once the device was recalled as far as measuring
the level of toxic metals in the body, Pinnacle patients are not receiving the
same level of preventative care simply because the device has not yet been
recalled.
A study done in March of
2011 reported the failure rate for the ASR to be nearly fifty percent six years
after surgery—a number which is four times as high as the failure rate claimed
by DePuy when the implant was recalled. It is believed this rate could be as
high as 80% eight years following the initial surgery. The Pinnacle failure
rate is predicted to climb from 8% to 16% at six and a half years. In the end,
while the Pinnacle is a slightly different science than the ASR, it still has a
good chance of releasing chromium and cobalt into the body.
Andrew
Sullo, Class Action Lead Counsel & Managing Partner of Sullo & Sullo
notes that “More
than 50% of our ASR hip recipient docket has already received revisions,”
and the expectation is that Pinnacle recipients with metal-on-metal hips will
soon follow suit. It is very important that you contact a Sullo & Sullo
attorney whether you have an ASR or a Pinnacle metal hip implant in your body
and even if you have not yet experienced adverse effects. Don’t
wait—call us now for invaluable information and assistance.
