By Independent Staff Writer
In a previous article we wrote on bone deterioration,
we discussed how the bones of your hip are constructed and how a hip
implant strives to mimic the qualities so that you can maintain a normal
range of movement and a fairly active life.
In
this article, we'd like to show you how the ASR XL Acetabular System
was constructed - and why it fell so short of what hip implant patients
needed to give them back their previous quality of life.
What a Hip Implant is Up Against
Any
hip implant is going head-to-head against the natural construction of
your body, which is no easy feat. What we think of as our hip is
actually two bones: the acetabulum (also called the hip socket) and the
femoral head, which is the rounded top of your femur (the main bone that
runs the length of your thigh).
As
you can see, the two bones of your hip are actually attached to each
other securely by two ligaments. The shorter ligament at the center of
the femur head is the transverse acetabular ligament, while the longer
ligament that runs from the ilium down to the femur itself is the
iliofemoral ligament.
These ligaments,
along with the cartilage surrounding the hip joint, are the reason your
hip doesn't dislocate on a regular basis. The iliofemoral ligament in
particular is extraordinarily strong - in fact, the strongest ligament
in the human body - and when you are standing or sitting, this ligament
flexes or releases to allow a range of movement without letting the hip
move out of the socket.
For its part,
the transverse acetabular ligament and the surrounding cartilage make up
the acetabular labrum, whose purpose is to deepen the hip socket so
that the head of the femur can't slip out. The deeper the hip socket,
the more secure the femur bone becomes and the less likely your hip will
dislocate.
When your natural hip is
removed to make way for a hip implant, neither of those ligaments is in
place, and the cushion of cartilage is removed to make way for an
artificial replacement. Removing the labrum means that your hip is 92% more likely to suffer contact stresses and 40% more likely to allow the femur and acetabulum to touch.
As
you can see, your hip is a sophisticated and well-constructed
mechanism, and it is extremely difficult to create a man-made
replacement for it. Let's take a look at some of the best attempts
available in the form of conventional hip replacement and total hip
replacement systems, including the ASR Acetabular System.
Conventional Hip Replacement (also called Conventional Hip Arthroplasty)
In
a conventional hip replacement, the acetabulum is resurfaced with a new
socket, replacing the ring of cartilage as pictured above with an
artificial cup made of plastic, ceramic, or metal. The head of the femur
is then removed and replaced with a long stem capped with a ball meant
to mimic the femur head, as shown below:
In
the conventional hip replacement, the plastic cup above is meant to act
as the bearing surface, which means that it is the location where the
ball and socket contact each other. The liner cushions the point of
contact, but it also makes the socket more shallow, which can mean less
range of movement and a higher likelihood of dislocation.
The
creators of the total hip replacement system hoped to eliminate the
problems associated with conventional hip replacement by boldly doing
away with a piece of the original design.
Total Hip Replacement
The
socket on a conventional hip replacement was technically composed of
two pieces: the acetabular cup and the plastic liner, the latter fitting
snugly into the former. In a total hip replacement, the design simply
eliminated the plastic liner, fitting the femoral head directly into the
acetabular cup.
You can see the
difference in the image below. The top implant [Fig. 3] is a
conventional hip replacement system, with an acetabular cup, a poly
(plastic) liner, and a femoral head. The lower implant [Fig. 4] is a
total hip replacement system, with only an acetabular cup and femoral
head.
This
design allowed the femoral head to be much larger, which made it more
stable and less likely to dislocate. It also meant, however, that there
was no cushion between the two hard surfaces of the acetabular cup and
the femoral head.
Many total hip
replacement systems are extremely successful, and many surgeons prefer
them over the two-piece conventional hip replacement systems,
particularly for younger patients who are more active and more likely to
dislocate their hip implant by testing the limits of its range of
movement.
However, the one-piece
system made meticulous design engineering absolutely essential to avoid
friction between the acetabular cup and the femoral head.
Which is where DePuy's ASR Acetabular System went wrong.
ASR XL Acetabular Total Hip Replacement System
The
ASR XL Acetabular System is a total hip replacement system that uses
the model in Fig. 4 above. It uses a traditional femoral ball and stem,
and has a 1-piece metal bearing socket placed in the acetabulum. The
"ASR" in the title is simply DePuy's trademark designation for this
class of single-piece sockets, while the "XL" refers to the fact that
DePuy made their implant available in larger sizes for patients whose
bodies could accommodate them.
As
we've already explained, much of the cushioning and connecting tissue
that would normally keep your hip bones properly in place have been
removed to accommodate a hip implant. Much of the cartilage is missing, which studies have shown
decreases the amount of synovial fluid available to lubricate the
joint. The synovial fluid will have an even more difficult time
lubricating the joint if the implant has been poorly designed,
restricting the flow of fluid between the pieces of the hip implant.
Poor
lubrication can cause patients a great deal of pain, but it can also
cause friction between the femoral head and socket, encouraging
particles of the implant to detach and enter the bloodstream. If the
friction is sufficient, the accumulation of metal ions in the
bloodstream and the surrounding tissue can cause metallosis, heavy metal poisoning, metal sensitivity, bone deterioration and tissue damage.
The
evidence is mounting to show that the DePuy ASR XL Acetabular system
was so poorly designed that the friction between ball and socket is far
beyond normal, and in fact may be causing all of the problems above in
an inordinate percentage of patients.
Furthermore,
several doctors who have analyzed the case say that even without the
medical consequences to patients' overall health, the ASR XL Acetabular
System is still failing at catastrophic rates purely because the design
is not made to wear well over time. DePuy has acknowledged a failure rate of 13%, which is astronomically higher than the usual failure rate for hip implants overall at .5-3%.
A
hip implant is the only option for many people who have suffered
extreme trauma or have arthritis, osteoporosis, or other debilitating
diseases. It is unconscionable that any company allowed an
insufficiently tested hip implant to get to market and be placed in
thousands of people.DePuy compounded this error
with their decision to keep the ASR Acetabular System on the market for
three years after it had received notification of high revision rates
in Australia.
If you believe you have
an ASR Acetabular System and would like more information on your legal
rights and your medical health, we'd like to help. Please give us a call
at 800-730-7607 or fill out our contact form, and we'll do everything we can to make sure you have the information you need to move forward.
