LARGE SCALE MECHANISMS TO MONITOR JOINT IMPLANTATION
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One of your patients undergoes routine hip replacement
surgery. Months later you learn that they are now suffering with significant
pain that appears to be secondary to the procedure. What is next for this
patient? Is there a bona fide mechanism through which we can report both
positive and negative procedural outcomes?
You are listening to ReachMD XM 157, the channel for
Welcome to a special segment focused on healthcare
I am your host, Dr. Mark Nolan Hill, professor of surgery
and practicing general surgeon and our guest is Dr. William Jiranek, Associate
Professor of Orthopedics and Chief of the Adult Reconstruction Section of
Orthopedic Surgery at the Virginia Commonwealth University School of Medicine.
Dr. Jiranek. currently leads a campaign across the State of Virginia to create
a statewide joint registry.
Welcome Dr. Jiranek.
Thanks for having me, Mark, great to be with you.
Dr. Jiranek, you hear about these incidences where patients
are in agony months after a hip replacement. What are your thoughts about
this? Why do they have pain?
I think there are a lot of reasons that people have pain and
not all of them have to do with the implants. Some of them have to do with the
patients; some of them have to do with the surgeon, I am sure. The reason that
we are interested in this is there is not a good mechanism to track those
problems in aggregate and so people hear about an isolated problem that patient
A has, but they do not see how all the patients in the state or a country are
doing and that's where we think that picking up on those trends in certain
types of surgery and certain implants may help us protect patients. That's why
we are trying to put this thing together.
When you look at a patient and they have certain symptoms,
how can you differentiate between a defective implant or some other process
going on that has nothing to do with the prosthetic itself?
Well, I think that's why people go to medical school and why
they train the orthopedist and they are fairly straightforward algorithms that
we use to help diagnose a patient’s pain. Certainly, history has always been
the first thing you do, we all know that, and then physical exam and then
radiographic studies. So certainly we learn a lot just from the history and
the physical exam and that's often corroborated just by plain x-rays. We
occasionally use more advanced studies CT, MRI, or nuclear studies.
When we talk about a defective device, what is the defect we
are referring to?
Well, I think there can be many manifestations of defective
devices and what our registry hopes to collect is people who end up having to
have repeat surgery as a result of some problem with their replacement and that
can be everything from an infection to recurrent dislocations to an actual
problem with the implant that causes failure of the implant become fixed to the
bone or premature loosening or an allergic reaction to some of the materials.
There are lots of things that can happen to implants.
You know I can only speak from the general surgery
perspective, but when we are learning and training about new prosthetic devices
that we use in general surgery, the training we receive is actually from the
manufacturer. Is this the same way in orthopedics and is this the best way to
Yeah! I don't think that, the training is largely what we
learn as residents and fellows and then from our patients; I would say that
industry-sponsored training programs are part of an orthopedic surgeon’s
learning process, but I would not say that they are the most important and in
some cases, they are not very important at all.
How common are prosthetic device problems?
Well, that's a very good question, and I think without a
registry it's hard to know. You know our reporting system thus far has been
reporting adverse outcomes to the FDA and I think both the FDA and most
surgeons agree that the process by which we report that is not a good one and
consequently the adverse responses are under reported.
What about when you talk to other orthopedic surgeons?
Well, when we look in other registries and other countries,
Australia, England, Sweden, for example; I can't give you a specific percentage
like 5% of all joint implants are defective and are bad, but they have been
able to identify implants that don't work as well as our Gold Standard Implants
and therefore questioned whether those implants should be on the market and
have induced changes from manufacturers of those implants.
Doctor, what if we need a widespread device review. Who
would lead the review? Would it be the manufacturer or would there be other
organizations that lead this and guide us?
It's my personal feeling that it should be led by the
patient’s advocate and I think the patient’s advocate is foremost their
physician. So I strongly feel that review of registry data should be done by
Is there a database for this?
There isn't currently, which is why we are trying to get one
started in the State of Virginia and hopefully in other states across the US.
There are databases that exist in other countries.
Well how does this information then get transmitted from
orthopedic surgeon to orthopedic surgeon?
The idea is that the way it is transmitted in other
countries, it is posted on a website available for the general public as well
as other surgeons and that's what we envision happening in this country as
How do the manufacturers feel about this national registry?
Well, I think that manufacturers have had some interest in
supporting this kind of initiative, but it has not been well organized thus
far. I wouldn't say that they have taken steps to try and avoid the
development of a registry at all, but they have not developed internal
registries within their companies.
How did you personally deal with the first time or multiple
times that you have had defective devices with respect to your communications
with the manufacturer?
The current process is to report it to the FDA and we have
done that. We have given feedback when there is not a gross adverse response
to the manufacturer of things that are not working well and I think that
generally they are quite responsive.
They do not try to fight you and say that it's indeed not
the device itself?
Well, in some cases, and we could run through a litany of
products that the manufacturer felt that perhaps the problem was not with the
product, but with the surgeon and how it was implanted and that is the impasse
that we often find ourselves and that delay while that is figured out causes
lots of the other patients to have the same device and potentially with the
What do you tell to the patients?
About a device that we think is abnormal; it depends if it's
a patient who has that device and is not doing well, we give them the diagnosis
and talk about a solution problem and what we think caused the problem and I
think then it's up to the patient to decide what they are doing from there?
Now Medicare has recently released what they call “never
events,” is this a “never event?”
I kind of disagree with the current Medicare “never
events.” For example, two of the things that they say are “never events” are
infection of a hip prosthesis and deep vein thrombosis, both of which we know
even in the best of circumstances or best of hospitals still exist and will
continue to exist, so never does it really make sense. How do you apply
'never' to a prosthesis. A prosthesis would never ingrow, or if a prosthesis
didn't ingrow, didn't become fixed to the bone is that a “never event?” Well,
there are a lot of things that can lead to a bone not fixing to a prosthesis
other than a defect in the manufacturing and that's where it gets sticky. So I
don't think they could really say that an adverse response to a prosthesis is a
“never event.” I think there would be too many individual differing
circumstances to be able to come up with a blanket "never" rule. I
think the whole concept of a "never" is pretty crazy in medicine
because both you and I and everybody else listening have seen everything that
can happen, does happen.
I think everyone listening agrees with you 100% on that, but
when we talk about the times when patients have to have their prosthetics
changed because of a defect, who covers this cost of surgery?
Well, it's interesting if a manufacturer has issued a
recall, the manufacturer covers the problem or a settlement is developed. If
the problem is not identified, then the insurer covers the problem, which is
why a lot of insurers including HIPAA are very interested in this problem and
how big a problem it actually is.
Now, do we have plaintiff lawyers breathing down the neck of
the patients who might require this type of surgery?
Well, it's interesting. There was an article in the New
York Times about registries that mentioned specific companies, specific product
and that week after that article I googled the name of the product and the
first four pages were attorney websites. So I think it's a real problem and it
highlights how we deal with this data. If we do identify a problem that is
more common with the specific prosthesis, how do we induce a change without
driving everybody into bankruptcy?
In general surgery, one of the most common procedures that I
do obviously are hernias, and as you are well aware, there was a prosthetic
that had significant problems. I received, when this became public, many, many
calls from patients over the ensuing months asking if they had this type of
mesh implanted and I could tell by their demeanor and their tone that they were
potentially very, very worried. When you have had a device that has been made
public as one that has been recalled and such like that, do you get calls like
that from the patients and you implanted them?
Oh, very commonly a lot of those calls and lot of it is
reassurance, but you are right, it's something that induces a lot of
Well, what do you say to the patient who has one of these
devices, but not having a problem?
Well, exactly that. I tell them that it is the prosthesis
under question, but not all of these prostheses have had problems and that we
would continue to monitor their status.
I want to thank our guest, Dr. William Jiranek.
We have been discussing large scale mechanisms to monitor
joint implantation outcomes.
I am Dr. Mark Nolan Hill and you have been listening to a
special segment focused on healthcare policy on ReachMD XM 157, the channel for
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