By Independent Staff Writer
In
2003, DePuy released the ASRTM XL Acetabular System, a hip implant that
was touted to last up to 20 years with a stronger, more durable
metal-on-metal design. Approximately 93,000 people around the world
weighed the risks of surgery against their current level of pain and
discomfort and chose to receive a hip implant that they believed would
give them 15 to 20 years of pain-free movement.
DePuy
issued a hip recall earlier this year, which means a disturbing number
of those patients will likely have to undergo a hip revision
surgery-years ahead of schedule.
With
a typical hip replacement, the patient is able to resume a normal life
after three to six months of recovery. There are a number of "common"
problems, such as loosening joints, fractures, and occasionally
dislocation. Hip implant recipients are informed beforehand that the
risk of these types of failure is .5-3%
The
admitted failure rate of the ASR XL Acetabular System is 13%-meaning,
this is the number acknowledged by DePuy. Mounting evidence suggests
that the failure rate is higher than that, especially if one doesn't
limit the definition of "failure" to DePuy's narrow view.
The major flaw, as we've said in other articles about the problems with the XL Acetabular System,
is the engineering. The two pieces of the implant rub together as the
patient moves, releasing microscopic particles of chromium and cobalt
into the bloodstream. Some patients experience pain when this happens;
others have no idea of the damage being done to the bone and tissue
surrounding the hip implant. Some patients and doctors have reported a
loosening of the joints in the hip implant, fracturing of the
surrounding bone, and full-out dislocation.
Every
hip implant releases small particles of the device's materials into the
bloodstream, but the quantities are so small that the body can release
them from the bloodstream as waste. In the ASR XL Acetabular System, the
quantities being released are sometimes so great that the body can't
get rid of them efficiently, causing metallosis.
According
to DePuy's website, "the patients who reported problems in the first
five years and had revision surgery reported a variety of symptoms." So
far, DePuy hasn't listed those symptoms on their website, but the
current evidence reveals metal poisoning, bone deterioration, and tissue necrosis, as well as metallosis.
Before
any surgery, the surgeon is required to meet with the patient and go
over the potential risks. Most people are familiar with the idea of
informed consent, which essentially states that patients should
understand the facts, implications, and future consequences of any
medical decision they're being asked to make.
With
hip implant surgery, the potential problems include malignant
hyperthermia, infections, respiratory issues, and blood clots that can
cause strokes. These are the basic risks for any major surgery; a hip
implant patient would've been informed of that fact. The recovery
process also has risks, as does refusing to have the surgery. Risks are
part of the decision to receive or not receive a hip implant.
However,
DePuy never informed the patients who were receiving the ASR XL
Acetabular System that their hip implant might have a number of risks
above and beyond those of major surgery. DePuy never informed the
surgeon performing the procedure that the hip implant's engineering hadn't been tested by the FDA-or that many patients, especially women, had already reported problems only a few years into the life of their hip implant.
DePuy
certainly failed to inform both the surgeons and the patients that
their product could mean a revision surgery in less than three years-a
fraction of the 15- to 20-year time frame their advertising campaign
promised.
The hip implants recall issued by DePuy
was voluntary-but it was too little too late. According to their
website, "DePuy intends to cover reasonable and customary costs of
testing and treatment associated with the ASR recall, including revision
surgery if it is necessary... This will allow DePuy to process other
reasonable out-of-pocket costs, such as lost work time and travel
expenses, which may be reimbursed. These costs will be more clearly
defined shortly and are subject to review on a case-by-case basis."
"Out-of-pocket
costs" means everything that's not covered by the insurance company-and
insurance companies haven't exactly developed a reputation for being
forthcoming with treatments that keep the patient's health at the
forefront of considering factors. They're more likely to choose the
least costly option, which means that many of these patients will find
themselves in a lawsuit over what is and is not a necessary medical
procedure.
This is the last thing any
of these patients with failing hip implants needs. They needed a hip
implant-not costly procedures and legal battles to make sure they get
the care they need to replace the damage that was done. They also need
full compensation for all their losses and damages, not just
out-of-pocket costs.
Every patient
who undergoes major surgery takes a risk. Those who received a DePuy ASR
XL Acetabular System weren't merely asked to take a risk,
however-they're being asked to take the fall.
