Updated recommendations re the decision: Depuy hip revision or not.

I received a key recommendation from one of my consults yesterday.  Recall that not all of my consults are in agreement as to how I should proceed. The recommendation:  Strong consideration should be given to revise this hip.  Why?

1)      High levels of cobalt

2)      High levels of chromium

3)      Osteolyis present

4)      Soft tissue damage present

5)      Known issues with the Depuy hip.

The really important points to take away from this:

1)      There is no one thing that should drive the decision to revise or not but rather, consider the big picture with your physcians

2)      I AM CURRENTLY ASYMPTOMATIC that is, I am experiencing no pain.....yet I have strong indications now to revise this hip.

Comments on Postmortem study of femoral osteolysis associated with metal-on-metal articulation in total hip replacement: an analysis of nine cases.

I found this study to be very interesting.  It shows that of the 7 revision  patients reviewed in autopsy  who  died between three and ten years after arthroplasty,  six of the seven were asymptomatic at the time of death!  I have no idea how old these people were nor what the other presenting issues were at time of death but I have repeatedly pointed out on this blog that I think there are many patients out there with the MOM hip who have not been tested for anything because they are asymptomatic.

 

The study suggests there may be frequent, unappreciated femoral bone loss and local immunological response in patients with second-generation metal-on-metal hip implants.   Note the words:  frequent and unappreciated......

 

Connie

 

 

J Bone Joint Surg Am. 2010 Jul 21;92(8):1720-31.

Huber M, Reinisch G, Zenz P, Zweymüller K, Lintner F.

Institute of Pathology and Bacteriology, SMZ Otto Wagner Spital, Baumgartner Hoehe 1, 1145 Vienna, Austria. Monika.Huber@wienkav.at

Abstract

BACKGROUND: Improved metal-on-metal articulations were reintroduced in total hip replacement to avoid the osteolysis sometimes seen with conventional ultra-high molecular weight polyethylene bearings. Osteolysis and local lymphocytic infiltration have been reported at revision of some metal-on-metal devices. We report similar and additional results in a study of second-generation metal-on-metal hip implants retrieved post mortem.

METHODS: Components and surrounding tissues were collected post mortem from seven patients with nine total hip replacements (Zweymüller SL stem with an Alloclassic cup) with Metasul metal-on-metal articulations. All available patient information was recorded. Radiographs of the hips were evaluated for osteolysis. Sections of joint capsule as well as of the femoral implant with surrounding bone were reviewed, and energy-dispersive x-ray analysis was used to evaluate the composition of wear products. The amount of wear was measured for each component (nine femoral heads and eight cup inserts), when possible, by a coordinate measurement machine with use of the dimensional method.

RESULTS: The patients died between three and ten years after arthroplasty, and six of the seven were asymptomatic at the time of death. One patient, with the highest rate of total wear (i.e., wear of femoral head and acetabular cup; 7.6 microm/yr), had increasing hip pain for one year, and histological analysis confirmed the radiographic findings of osteolysis. For two other patients, histological analysis confirmed the radiographic findings of asymptomatic osteolysis. For three patients, histological analysis revealed osteolysis that had escaped conventional radiographic analysis. Joint capsule tissue showed evidence of metallosis in all hips and local lymphocytic infiltration in eight hips. Energy-dispersive x-ray analysis revealed elements attributable to CoCrMo alloy in all hips and traces of corrosion products in three hips.

CONCLUSIONS: The postmortem findings of osteolysis and/or lymphocytic infiltration associated with eight clinically well-functioning, low wear devices (a total wear rate of <4 microm/yr) suggest there may be frequent, unappreciated femoral bone loss and local immunological response in patients with second-generation metal-on-metal hip implants. Compared with previous postmortem studies, our findings showed the extent of osteolysis was similar to that with metal-on-polyethylene articulations.

Who says Depuy won’t reimburse for reasonable medical expenses?

There seem to be lots of criticism (filed by lawyers not patients) discussing what Depuy will and will not reimburse and what exactly has to be signed in order to obtain that reimbursement. First I can tell you as a patient, Depuy and Broadspire, their clam’s agent, have been nothing but helpful and responsive to my submissions of medical claims.  In fact, Broadspire has reimbursed me within a week of the first set of claims I sent to them. That is for direct out of pocket expense incurred by me, they provide rapid reimbursement.  They reimburse considerably faster than Blue Cross does I can surely tell you that!

Second, just as in any medical reimbursement situation, Broadspire will insist on one thing prior to reimbursement: some type of proof that you have the Depuy hip implant.  I find that request reasonable and necessary.  I don’t know of any company that will reimburse you for issues with a product if they don’t have proof that you have the product.  Makes complete sense to me. 

Third, you don’t have to sign away anything in order to get reimbursed.  You do have to provide proof that you have the depuy hip implant and you can do that by just sending in the OR (operating room) report.  That report is a summary of what was done during the surgery and the report contains the name of the implant that the surgeon used.  Your other option is to have the orthopedic surgeon release the information by signing a release form with your physcians.  I don’t care for that option because I want my physicians to come back and get my permission any time they are requested to release medical records on my behalf.

If you have had any other experiences with the Depuy claims process, please let me know. 

The only thing I find  to be annoying is the manner in which Blue Cross handles the routine submission of the Depuy claims.  The process as I understand it, is that your insurance company (in this case my insurance company is Blue Cross) is suppose to pay the claim and subrogate to Depuy.  In theory this sounds great however, Blue cross has no procedure in place to identify which incoming claims are related to Depuy so they pay everything and then send me a summary of what they paid and  what I am responsible for paying.  I then receive a bill from the provider.   When I call Blue Cross to notify them that the expenses are all to be subrogated to Depuy, I wait on the phone for 10 minutes each time until the customer service rep du jour reads my records to then confirm they have a note in my policy to submit the claims to Depuy.  It is a very, very inefficient process.

In January for example, I had 3 radiology appointments, 6 lab tests and 3-4 physician appointments all related to Depuy. Given I have not reached the deductibles; I am responsible for the payments. Now I will be taking a different tact which is to just send the invoices to Depuy myself in those cases rather than going back to the insurance company.  It’s faster than going back to the insurance company and then waiting for them to subrogate to Depuy. 

If the insurance company has in fact made the reimbursement though, you have to go back through them.

Interesting tidbits from the 12 videos on Depuy hip/metal ion issues by Dr. Michael McCabe, Toxicologist.

(1)   Dr. McCabe seems to be well qualified to comment on the metal ion issues.  While he is not a medical doctor, he is a Phd and Toxicologist.  His specialty is the effects of heavy metal on the Immune response, aka Immunotoxicology.

a.       The first time I heard about the potential relationship between this hip and the Immune issues is from the Toxicologist I went to see last week.

(2)   He claims that it has been shown in the literature that chromium 3 (the non toxic trivalent form) can produce carcinogenic mechanisms by stimulating the immune response through   inflammation.   If the inflammation goes unchecked, then this can contribute to the development of the cancer etc. The literature is all environmental evidence and not evidence that shows a link between the hip and cancer.  The one fact is that inflammation is known as a progressive factor in causing cancers environmentally.  (from video number 8 of 12)

Interesting because this suggests to me that if the MRI shows any level of inflammation regardless of whether you are experiencing pain, this is yet one additional piece of critical information that should be considered in combination of other issues in making a revision decision.

(3)   He reiterates that the three things to look at for cobalt toxicity with the hip are:

a.       Cardiomyopathy-swelling of the heart

b.      Hypothyroidism

c.       Some neurotoxic issues (not sure what these are but will look into it.)

(4)   He reiterates that if you are exposed to over 5 parts per billion of cobalt, the environmental FDA regulations are such that you should be removed from the exposure.  No one knows what it means re the hip however, I like his approach which is to say:  how might the environmental observations inform us as to how we might view the hip.  I think that is a good way to look at this.  Many physicians seem to dismiss the environmental observations (inhalation, dermatitis) and I don’t know that this is a reasonable thing to do.  I think it is a data point that should not be dismissed out of hand but rather considered in the big picture.

(5)   Elevated cobalt level is not cumulative but is coming from an active source which is from wear debris from the hip.  If the hip is removed, cobalt will decrease over time…red blood cells will turn over every 3 months.  In approximately 3 months those levels should decrease if the hip is removed.   You are not completely out of the woods however,  even after revision because you have the potential to stimulate immune response..  long term immunological issues still exist post revision.

(6)   Do high Co and Cr levels cause cancer?  Both in vitro and in vivo studies suggest there is imunogenisis in the DNA etc.  There are no epidemiological studies to close that loop and solidify the claim that the changes in DNA (chromosomal changes) cause cancer.    Given there are health consequences (heart/hypothyroidism/ neurotoxic issues), there are potentially carcinogenic issues that might surface.

He is quite sympathetic with the position the orthopedic surgeons are in as the symptom complex is complicated and we seem to have no direct data that proves anything.  The physicians are left in a really bad position as are the patients to have to interpret things without a lot of information.  My orthopedic surgeon summarized this whole thing in 3 words:  It’s all murky!

12 Wonderful short YouTube Videos by a medical toxicologist on Depuy hip toxicity issues

I highly, highly, highly recommend viewing this series of  2-3 minute each youtube videos if you want to understand the metal toxicology issues surrounding the Depuy hip.  They are really, really, great! I will summarize the key points in them over the next few days.  Enjoy!  They are in easy to understand videos....nicely done and I found them to be quite factual despite the fact that  some litigation firm paid for them!


 Metal Toxicologist Part 1: Background & Expertise of toxicology expert Dr. Michael McCabe

Metal Toxicology Expert Part 2:DePuy ASR Hip Replacement Recall

Metal Toxicology Expert Part 3: Effects of elevated cobalt & chromium levels

Metal Toxicology Expert Part 4: Testing blood for cobalt and chromium - "Trace ...

Metal Toxicology Expert Part 5: What studies have been conducted regarding cobalt exposure?

Metal Toxicology Expert Part 6: What are the effects of elevated blood cobalt levels ...

Metal Toxicology Expert Part 7: Symptoms of Cobaltism

Metal Toxicology Expert Part 8: Effects of high levels of chromium

Metal Toxicology Expert Part 9: Effects of metal wear debris from metal hip implants

Metal Toxicologist Part 10: Cobalt blood levels after hip replacement revision surgery

Metal Toxicologist Part 11: Should all metal-on-metal hip implants be ...

Metal Toxicology Expert Part 12: Do high cobalt and chromium blood levels cause cancer ...

Thanks to Twitter, I found these videos!

 I signed up the mydepuyhip URL on twitter so these posts are now appearing on twitter automatically when I post them on the blog.

Connie

Is there a casual relationship between metal hypersensitivity and osteolyis with Depuy hip?

Could there be a link between osteolyis and metal hypersensitivity potentially from a parathyroid issue?  Bone resorption (aka osteolyis) is the process by which osteoclasts break down bone^[1] and release the minerals, resulting in a transfer of calcium from bone fluid to the blood.  Osteoclasts are also prominent in the tissue destruction.

Calcium-sensing membrane receptors in the parathyroid gland monitor calcium levels in the extracellular fluid.  Low levels of calcium stimulate the release of parathyroid hormone (PTH) from chief cells of the parathyroid gland. In addition to its effects on kidney and intestine, PTH also increases the number and activity of osteoclasts to release calcium from bone, and thus stimulates bone resorption.

High levels of calcium in the blood, on the other hand, leads to decreased PTH release from the parathyroid gland, decreasing the number and activity of osteoclasts, resulting in less bone resorption.

If you are asymptomatic with a depuy hip, on your next vist to your physcian, I would ask to see  your calcium levels and PTH levels since you had the hip implant.  Ask your physcian if the levels are high or low consistantly since the implant?   Low calcium levels might contribute to higher bone resporption.

Connie

….. While awaiting a decision from my team: Depuy hip Revision or not?

I have been thinking a lot about the process I have gone through since the announcement of the Depuy hip recall last year in an attempt to assemble the requisite information to make the decision: revise or not. I have sought information from the people who are “experts” in this field because I was unable to make this decision due to the lack of information available to guide a decision. In retrospect, my personal thoughts:

 The overriding observation: the overall approach to this problem seems to be somewhat problematic to me.

o   Symptomatic vs non symptomatic should not be an issue in proceeding with testing for underlying problems that may be present.  If we know that the soft tissue and bone damage is progressive and we don’t know how often it occurs with MOM asymptomatic patients, appropriate medical protocol should be undertaken: “Do no harm”.  Up holding that oath should be the key defining the procedures. Simple, albeit expensive tests, can be done to uncover any harm/issues if the tests are conducted by the right people with the right protocols and equipment.

o   The tests used should be those that are KNOWN to provide the optimum ability to detect any damage that has occurred and the severity of that damage and  then assessed in concert with all information.

§  The sonogram on the hip recommendation- The sonogram provides a very different resolution on the hip vs a MRI Mavrick protocol. In my case, had I based my decision based on that sonogram, I would have likely done nothing.

·         My sonogram indicated “the soft tissues are grossly unremarkable.”

·         The MRI did not indicate that all.  There was instances of both soft tissue damage and bone damage (osteolysis), albeit no infection was evident  which is likely why I have no pain at the moment.

§  The toxicity tests should be conducted with the appropriate reporting data in order that the test results are put in a meaningful perspective. What does it mean to have “high” levels if the levels are being compared to toxicity derived from the environment (skin, inhalation etc?.)  The answer could be something or nothing.  Who knows? 

o    Don’t wait to seek testing until you have pain.  Pain is something that develops over time and exposure to problem situations.  If there is evidence of something that might cause progressive deterioration, should that evidence not be surfaced prior to it causing pain and irreparable damage?

o   Don’t make decisions based on one piece of information but rather look at the big picture.  I don’t think any one of these items listed below alone, would make me replace this hip other than perhaps the pain.  Pain however, is not the only determinant for replacing this hip. These are the 4 things that one of my consults recommended reviewing:

§  Bone damage surfaced through the appropriate MRIs.

§  Soft tissue damage surfaced through the appropriate MRI

§  Metal ion levels associated with  chromium and cobalt

§  Track record of the hip implant (in this case the depuy implant)

·         Understand that there is not a lot of information out there on the progressive nature of the ions on the hip because baseline MRIs and toxicity levels are not run routinely in order to measure anything pre or post surgery.  You should also know that hospitals don’t run routine toxicity levels post mortem so we don’t have a lot of information surrounding the long term effects of this MOM hip on anything.  Pain is the first thing that would draw attention from the medical community but my question:  Are the patients experiencing pain just the initial tip of an iceberg?  If we know that the metal can cause progressive deterioration, how long does it take to surface that pain and once it does, it a bit late in the process?  Is there something that could have been done earlier to detect the start of the deterioration?

·         Make sure you steer your own ship of consultants to a decision that is informed on all sides with input from your team.  A decision rendered from any member of your team is uninformed absent collaboration between specialists.  Does it really matter what the radiologist says if that person doesn’t understand the toxicology issues?  NO. Does it matter what the lone surgeon says absent clear radiological evidence describing the situation that has occurred? NO.  I learned a lot from one of my consults that you must look at the big picture and put all of the puzzle pieces together before you make a decision. 

       My team consists of:

o   My orthopedic surgeon who initially performed the surgery

o   My internist (coordinating and serving as a quarterback who will collect all of the evidence and render her decision along with your orthopedic surgeon.)

o   A radiologist skilled at using the right protocol to provide optimum visibility into the soft tissue and bone ramifications.  These protocols are available by the leaders in the field so make sure you ask about the radiological protocol used before you do the MRI.  Is it MARS or MAVRICK protocal.  If it is neither, I would look elsewhere or ask about the most current methods to adequately uncover soft tissue and bone damage with this problem.

o   A toxicologist who “gets” the implication of these metals and who can ask appropriate questions about other symptoms or issues that you may not have linked to this problem.

o   A second orthopedic surgeon, experienced in revision surgery who can verify that the original hip was placed properly.  I surely wouldn’t use the same surgeon you used initially if the original surgery had placement issues. The exact angles of placement can be measured with the right equipment. Further/make sure you ask the surgeon doing the revision how many he/she has done and what the results were of them. (A general rule of thumb.  A normal orthopedic surgeon conducts about 500 surgeons per year…yep, about 10 a week. I would want to work with one who has 10-15% of his practice in revisions…Revisions are not simple procedures!  They are NOT!   They are not routine.  If you are dealing with someone who has only done a few of these, seek another surgeon who has the experience and understand thoroughly their track record before you move ahead.)

o   An orthopedic specialist who is very familiar with the research underlying the ions and the hip.  These are few and far between.  You have to do your homework to find them. This person may not be the best person to conduct a revision surgery by the way.

o   In my case, I added a nephrologists’ opinion due to my having only one kidney remaining knowing that the kidney is a “targeted” organ for one of the metals.

o   The toxicologist is recommending that I consult with an endocrinologist due to my diagnosis of something related to the thyroid.

Is it necessary to have so many opinions?  Absolutely not as most people dealing with this issue are symptomatic with pain. It is likely that if you are experiencing pain, this decision is quite a bit easier to make since you are in the category of being symptomatic.  Getting rid of the pain is the most important focus at that point.  I would however consider having the MRI and the toxicity tests prior to removing that hip and I believe this is the recommendation of Depuy.  If you are asymptomatic, assembling the pieces of the puzzel is more difficult.  The answers are not as obvious.  You have to collect the requisite information from your team of specialists.

The American Orthopedic Association assembled a panel of experts which I reported on at the end of January in a 5 part series. You can look at those panelists.  They all have active practices and are informed on all of the issues.

 Hope this all helps provide at least one perspective, a non medical perspective or patient perspective at that! Now that I have seen all of the consults, hoping to have a decision from my team in the next few weeks.

Best,

Connie

Do vitamins affect the cobalt and chromium toxicity tests?

After having spoken to Depuy, and two of my consults (orthopedic surgeon and toxicologist), I think this is a good summary of what I learned:

(1)   Depuy rep who takes patient questions recommended suspending vitamin intake 3 days prior to the test.

(2)   The blood lab for the orthopedic surgeon who focuses in ion testing  had no recommendation to patients to suspend vitamins prior to testing

(3)   The toxicologist said you just look at the vitamins to ensure that there is no cobalt in any of the vitamins especially B12.  He did not seem to recommend suspending vitamin intake prior the tests unless they have the metals in them you are being tested for.

Carcinogens and their relationship to the Depuy hip

The press and the lawyers are very much involved with publicizing the relationship between Chromium from the Depuy hip and cancer.  A few things to remember:

(1)   Most (not all) cancers associated with Chromium are found with Chromium 6

(2)   The Depuy hip contains Chromium 3 which is not typically associated with cancer.

(3)   Most of the studies I published were environmentally based, that is to say, the patients who developed toxicities did so environmentally.

(4)   Most toxicity cases involving chromium are local in that they involve the respiratory tract (inhaled) or the skin where a factory worker my come into contact with it.

(5)   What I find to be most interesting about Chromium is its ability to oxidize in some manner from 3 to 6 or 6 to 3.  That implies that the non carcinogen can oxidize to the carcinogen and vise a versa. 

(6)   The reported cases of this so called oxidation have occurred under specific industrial conditions.  I understand from the toxicologist that the juices in the stomach can cause that oxidation.

(7)   I am unaware of the other situations that can cause this especially systemically.

The uncertainty surrounding this oxidation process (what are all of the situations in the body that can cause the trivalent-non toxic form- to morph into the hexavalent form) is a big question in my mind.

connie

Hip revision and monitoring recommendations from the FDA site: Poppycock!

I was made aware of these recomendations by one of my consults a few days ago.  Last nite as I was reading these and  I concluded that these recommendations are preposterous!

I am one of these asymptomatic patients and speaking from only my experience,   anyone who has this  depuy hip should get two basic tests:

·         MRI with the appropriate MAVRICK or MARS protocol to enable high resolution of the soft tissue and bone associated with the implant  AND

·         Cobalt and Ion Toxicity test to view your levels.

Why?  Simple. Corrective action can be taken on two fronts if there are problems brewing below the surface while the  patient is asymptomatic:

(1)    You can stop the bone and tissue damage from progressing by removing the hip even if you have no pain

(2)   You can lower the cobalt and chromium levels in your blood at least (not sure about the organs) and given no one knows the long term effects of these metal levles on the organs, it can’t be a bad thing to lower them.  The levels will go down when the implant is removed so my consults tell me.

All of this has to be weighed of course against the risk of surgery with your medical team but for goodness sakes, you can’t just buy into an argument that states, no symptoms=no problems.

 Once I was tested (in an asymptomatic state) I found four things: (1) very high ion levels of both chromium and cobalt, (2) bone damage (aka ostyeolysis), (3) soft tissue damage and (4) a potential systemic link between my thyroid issue and the lead in this metal.    Bone and tissue damage will continue to occur unless the implant is removed. So advised one of my consults.

While each of these individually may not be enough to merit revision surgery, what happens when you are asymptomatic and you have all of these things?

While the FDA seems to recommend that asymptomatic patients should be followed up with a “careful exam”, I don’t see what merit can be found in doing that.  There is no harm in having the appropriate MRI done and certainly no harm in getting a baseline on your ion toxicity levels. The risks are likely higher if you simply do nothing.  Am I missing something here?

I have been writing this blog now for almost 4 months and I have never commented on anything being so preposterous as the recommendations below from the FDA.  Good Grief.  Is it better to be walking around with bone damage, soft tissue damage, high levels of metal ions and potential systemic toxicity and not know because a patient is asymptomatic and didn’t bother to get tested?  If the FDA is reading this site, please advise what kind of thinking lead to this conclusion.  If I am missing something, I would be happy to retract this!

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241667.htm

Copied from the FDA site verbatium:

Device Revisions

• At this time, there is insufficient scientific data to provide a rigorous science-based recommendation for a threshold value of metal ion levels in the blood that would serve as a trigger for intervention or revision.

[Comment by Connie:  I agree with the above statement but when the levels are taken into account with a complex of issues such as soft tissue damage, and osteolysis, this statement is highly suspect.  The big picture needs to be investigated symptomatic or not.  If I had all of these problems in an asymptomatic state, how many other people have these same issues going on?  I will send a note to Depuy about this.

Follow-Up for Asymptomatic Patients (From the FDA site verbatium)

Clinical Evaluation

• Follow-up of asymptomatic metal-on-metal (MoM) patients should occur periodically.
• Patients, including the following, are at risk for increased device wear and/or adverse reactions to metal debris and should be monitored closely:
• Female patients
• Patients with increased activity
• Patients with malpositioned components
• Patients with bilateral implants
• Patients with evidence of renal insufficiency
• Patient follow-up visits should include:
• Careful exam which includes a functional assessment
• Physical examination for asymptomatic local swelling or masses
• Careful review of systems for general health changes and evidence of systemic effects (particularly as pertains to the cardiovascular, neurological, and thyroid systems)
• At this time, the utility of routine screening of asymptomatic patients using diagnostic soft tissue imaging and/or blood metal ion testing has not been established. Moreover, findings of lesions on soft tissue imaging, or of elevated blood metal ions, in the absence of symptoms, though reported in a limited number of research studies for some MoM hip implant patients, are difficult to interpret because:
• The exact incidence or prevalence of asymptomatic lesions and their natural history is not known
• The correlation between elevated blood metal ions and development of future local or systemic system adverse reactions is not well established

Interesting findings from my final two consults-will share in sequence over the next 4 days.

My final consultations yesterday resulted in some interesting findings from my perspective in five ways:

(1)    Some solid criteria for making the decision to have a revision surgery was suggested by the consults.  I was very happy to receive the feedback.  That summary appears below.

(will cover the rest below in subsequent posts.)

(2)    What I uncovered re the FDA’s perspective of the issues from one of the consults

(3)    My understanding from the  toxicology consult with respect to a number of issues we have discussed previously in the blog re chromium and cobalt toxicity.

(4)    Testing for chromium and cobalt toxicity.

(5)    Vitamin abstinence prior to taking the chromium and cobalt tests

I spent the day with the last two consults with whom I wanted to touch base prior to my making a decision as to whether I should get the revision surgery.  For those of you who are just joining this blog, I am one of the patients who for the most part, is asymptomatic but I have very high ion levels of chromium and cobalt. So, we as patients face a conundrum right?  Should I do this or should I wait until I have painful symptoms?

 The first consult I met with was an Orthopedic  Surgeon specializing in ion toxicity.  He is a rare bird as I am sure most of you will agree, most orthopedic surgeons seem to know very little about this problem and rightfully so.  Most experts have very little information on the toxicity problem with this hip.  I told him I really had very little confidence in the process of making this decision and could he provide some key points that he would use to consider the process of seeking or not seeking a revision surgery when you are exhibiting no outward symptoms.  Here were his top 4 considerations (as a complex of considerations):

·         Track record of the implant irrespective of the patient-the current implant seems to have  issues.

·         High Metal ion levels-he considered my levels to be very high.  He said if the test levels I have are correct, he said that combined with the other three points would indicate strong consideration be given to a revision surgery (I revised this from yesterday as I didn't look at my notes prior to writing this bullet). He felt the deterioration of the tissue and the bone would continue unless the hip was removed and  my MRI indicated damage to both even though I don’t experience consistent pain.

·         Presence of osteolysis- The MRI confirmed that loss of bone has occurred.  He again felt that the deterioration would likely continue unless the hip was  removed.

·         Soft tissue damage-Tthe MRI confirmed that as well.

No decision was rendered because he wanted to review the tests from his own lab.   I repeated the blood tests with his own research lab since they have been running these tests with for 20 years and have the appropriate data to put the results in context.  He said unless you had the correct data, the test interpretation has little validity.  Apparently, most labs provide the context of chromium and cobalt results against the environmental exposure to these metals.  Gee, that was news to me!  I guess that seems reasonable though, given we have little information on the hips.

The second consult was a toxicologist and MD by training.  His mission is to look not for localized problems around the bone and tissue but rather, to search for systemic issues whereby the metal has caused problems in your body away from the hip.  He uses the FDA’s recommendation as to what to look for in hip toxicity cases:

·         Heart (chest pain, shortness of breath)

·         Nerves (numbness, weakness, changes in vision or hearing

·         Thyroid (fatigue, feeling cold, weight gain)

·         Kidney (change in urination habits.)

 It came as a surprise to me that both consults seem to latch onto a diagnosis I had been given about  5-6 years ago called Hashimoto Thyroiditis; coincidently, right around the time of this surgery.  They both seemed to think that there may be some kind of relation between high cobalt levels and thyroid issues.   I need to research this further.

  Connie