As
of this date the Pinnacle metal-on-metal hip implant device manufactured by
DePuy has not followed in the recall footsteps of DePuy’s other hip implant,
the ASR. While Johnson and Johnson and DePuy vigorously deny that the Pinnacle
has any problems—and, in fact, call it the best metal-on-metal hip implant on
the market today—many recipients of the device feel it has some of the same flaws
as the ASR. Both the Pinnacle and the ASR are manufactured by Johnson and
Johnson’s subsidiary company, DePuy. The Pinnacle made its debut in 2002 as the
predecessor of the ASR which followed in 2005. The ASR is strictly a
metal-on-metal hip implant device while the Pinnacle name includes
metal-on-ceramic and metal on polyethylene models as well.
Nearly
150,000 Pinnacle all-metal hip replacements have been implanted compared to
93,000 ASR’s worldwide—approximately half of those in the United States alone.
Both the Pinnacle and the ASR all-metal hip implants were approved under the
controversial 510(k) FDA approval process. This particular process allows the
majority of medical devices to get to market quickly by showing they are
substantially comparable to a device which has already gained approval. The
process also allows a product to get to market without expensive clinical
trials however in some cases the approval process has been predicated on a
device which is no longer marketed—even due to poor performance.
Between
the beginning of 2011 and September 30, 2011 some 1300 complaints have been
lodged with the FDA regarding the Pinnacle, and 500 for the ASR. While the
failure rate of the Pinnacle does not appear to be nearly the rate of the ASR,
it does share the same potential for metal toxicity as the ASR. When the metal
acetabular cup and ball—both made of cobalt and chromium—rub against one
another during the recipient’s activity the friction which results causes tiny
metal ions to shear off. These ions may either lodge in nearby muscle tissue,
eventually causing those muscles to decay, or could find their way to the
bloodstream where they can be responsible for a myriad of symptoms from
relatively minor to extremely severe.
Physicians
of ASR patients have documented serious negative health effects in the
cardiovascular, kidney, neurological and thyroid systems. While there has been
no hard data regarding cancer risk, patients with high levels of cobalt and
chromium in their bloodstream have noted extreme pain, degeneration of muscle
tissue, vision disturbances (and in some extreme cases, blindness) hearing
problems, balance and coordination issues, skin disorders, an inability to
distinguish between sweet and salty foods and memory loss. In the end the
Pinnacle has the same cobalt and chromium risks as the ASR even though it may
not be constructed with the exact same science.
Whether
a patient is implanted with an ASR or a Pinnacle device it is likely that
chromium and cobalt are shedding into the body causing metallosis, necrosis and
bone loss. Muscles behind the femoral head can be lost forever due to the
shedding metal ions and that muscle can never be regained. You can certainly
make the surrounding muscles stronger through exercise, but muscle does not
regenerate. This means that a recipient may begin to walk with a gait which
then turns into a limp, then soon they are using a cane, a walker, a
scooter—and finally they are left sitting in a chair, unable to walk and in
constant pain. DePuy claims their Pinnacle device has a smaller head which
minimizes the friction between the metal parts and are taking a hard line in
its defense.
DePuy
executives place the failure rate of the Pinnacle at 4-4.5% within five years
which is well within acceptable limits. Remember, however, that DePuy claimed
the ASR had a failure rate of approximately 12% when it was recalled, however
later studies show that the ASR has a 49% failure rate at 6 years and a
whopping 80% at eight years. Although the FDA ordered all metal-on-metal hip
implant manufacturers to conduct follow-up studies on all cases in which an
implant failure led to serious consequences, less than a quarter of the study
plans have been finalized—including DePuy’s.
Andrew
Sullo, Managing Partner and Class Action Lead Counsel of Sullo & Sullo, LLP
believes that the Pinnacle litigation will run approximately 12-18 months
behind the ASR litigation and that the hundreds of boxes off discovery provided
in the ASR lawsuits will be identical in many ways to the upcoming Pinnacle
discovery. Because Pinnacle recipients may well end up with many of the same
negative health effects as ASR recipients, those with either device should seek
qualified legal advice and assistance. Sullo wants all Pinnacle and ASR clients
to know that “Sullo & Sullo currently
has dozens of DePuy ASR and Pinnacle clients,” and that the highly
qualified Sullo attorneys will work hard to ensure all recipients of metal hip
implants are fully protected.
