My name is Hanna Viner, I am 61 years old and I live in Sydney, Australia. I had recently a left hip revision surgery from MoM BHR to ceramic THR. After subscribing to your blog and reading your very interesting articles and stories I have decided to share my experience with you. I have bilateral artificial hips. Left is ceramic THR, MoM BHR on the right side.

In October 2000 I had my first right hip MoM BHR put in due to severe osteoarthritis and 3 months after had developed a limp in the left leg and pain in the left hip. My surgeon, who was trained in BHR 6 months before my first operation, had gone to Birmingham to learn how to use Derek McMinn‘s BHR prosthesis and I was one of the first patient to receive this BHR prosthesis in Australia. Anyhow this operation was successful and help me enormously with the pain, which I had suffered for at least 3 years, I was 48 years old when I had my first operation.

Two years later in September 2002 I went and had left hip BHR inserted and this operation was not as successful as the first one. My surgeon has told me that the damage in the left acetabulum and femur head was not as great as in the right one therefore they have to insert a bigger socket and force it into the acetabulum, I think they maybe did not have the right size of the socket for damage I had there. The future CT Scan had showed an old healed fracture in my pelvis next to the left prosthesis. Anyhow i was happy to have the new hip resurfacing in and did not pay much attention to the details then.

From the beginning the left prosthesis was squeaking and made all sorts of noises while I was moving or bending, but I had a little pain and considered that ok. When I attended numerous check up visits with my surgeon I have told him about the problems but he dismissed them as normal. Over the years the noises and occasional pain were more disturbing and in 2007 my X-ray showed the lucency next to the left BHR, which again my doctor has dismissed and said that there is nothing to worry about.

So life was going on and I started having gait problem and developed excessive pronation in my feet, more severe on the left foot. I also developed bunions on both feet and I had to do something because due mainly to left foot drop I was falling while walking even on leveled ground and my feet were killing me, being very painful while walking or standing for prolonged periods.

After numerous fallings I have researched the cause for it and decided to go and see podiatrist, which of course diagnosed me with severe pronation of my feet, especially the left one. I was given orthotics and felt better immediately. I also stared to notice that the left leg was kind of weaker than the right one, but I did not pay too much attention and was living my life as normal.

Mean while this leg problems had affected my thoracic skoliosis and my shoulders were very uneven, more than ever before, the right one was now much lower than the left one. So I started paying attention to my posture. I work in the office and had to be aware the way I was sitting and using computer. My right knee developed Bakers cyst and was and is quite painful especially when I walk up the hill or up and down the stairs.

I also started being very fatigued and developed some chronic aches and pains all over my body, I had digestive problems, loss of vision especially at night and could not hear so well with my left ear. I also have done a comprehensive stool analysis test learning from it that i had some bacterias, amoebas and parasites, my immune system was already compromised and i did not know why. I was a healthy eater, non smoker and non drinker, I use to do lots of sport activities and i was very miserable, irritable and unhappy, thinking that all of this is due to menopause.

In 2009 I had an Idiopathic hemorrage in the back of my left eye,which disappeared after 4 months. My blood pressure was playing up, hot flushes and night sweets were there even I had finished menopause few years before (by the way that period of my life was a miserable one too) and I felt overall very sick. I started Chinese herbs and acupuncture treatment which somehow helped because it made my body stronger but many of my symptoms had never disappear.

Than in June 2012 I went to see my orthopedic surgeon for a check up, which was 5.5 years overdue, i should attend this check up 4 years after my las check up, it was 1.5 years overdue due to some family commitments in Poland, had to look after my elderly mother for 15 months there.

In winter 2011 in Poland I already realize that my left leg is getting weaker and weaker as I was not able to do long walks on the snow the way I was able to do it in winter 2010, but did not worry too much about it blaming the old age, I also developed thyroid problems, my TSH was climbing up and overall I looked terrible, I was swollen especially my face at the chin and neck and my hands and feet and started putting lots of weight.

When I came back to Australia I went and had all necessary blood tests including thyroid tests and tests showed a Hashimoto disease, all thyroid tests were at the normal range, but my thyroid antibodies were elevated to 208IU/mL and my cholesterol was slightly elevated and some of the liver functions as ALT GGT and ALP were elevated. This started to worry me a bit. I did hip X-rays and went for a check up. I have already read the description written by radiologist, which showed that I have some overgrowth on the femur near the left prosthesis. I had showed that o my surgeon and he decided that we need to investigate this further, he had send me for a CT scan and a nuclear bone scan and I had also requested the metal ions blood test.

We did all of that and, o boy, I had a big pseudo tumor next to my left hip, bone and surrounding tissues eaten away by metal debris and metal ions in thousands in my blood, I had no option but to have surgery ASAP so we have scheduled this surgery for hip revision for 25 October 2012. I was speechless and angry and I had no option but to go for this operation.

The operation was successfull but it was done at the lasy moment as the damage to my bone and surrounded tissue was so extensive that if I would left it unattended for a bit longer I wouldn’t have any hip left there.

My surgeon had to remove about a litter of fluid with metal debris and repair all surrounded tissue damage. I was given THR made out of ceramic with ceramic liner to last longer and with titanium stem, also he did a bone graft from my own bone scraps from the femur onto acetabulum and fix the socket there with 2 titanium screws. I was doing pretty ok after the op and after 5 days in hospital I went to rehab hospital for 2 weeks for further rehabilitation ( isometric exercises in the morning and hydrotherapy in the afternoon), this was a great help. When I got back home I have continued hydrotherapy every day of the week and it felt great.  It has been over 5 months now after the operation, I do continue hydrotherapy attending sessions at least twice a week.

I went back to work 2.5 months after the operation and I am taking systemic enzymes which are helping enormously with my scar tissue and swelling, they are great, I also detox with chlorella and am taking lots of supplements to keep me going, but I am still tired and the left leg is not fully healed yet, still getting a bit painful if I will overuse it. But the range of movement is great.

I have been back to see my surgeon with new xrays on 8/3/2013, the bone has healed terrifically well and my metal ions are substantially down: chromium from 1200 nmol/l to 574 nmol/l and cobalt from 1860 to 68, still high but much, much better. During this check up I have requested a removal of my right BHR prosthesis and my surgeon was surprised by my decision asking me – why do you want to remove a perfectly good device, I had answered that this is a ticking bomb an it could be blowing up at any rime, he answered yes potentially it can. We had scheduled another revision surgery for 26/6/13. Since then I had enough time to think about it and considering the fact that my left leg is still quite weak I have realized that I may not be well enough to perform the second revision so soon, besides my lower back is playing up since the last operation which is quite normal. I have requested an MRI scan for hips and lower back and measurement of metal ions in blood every three months and if all will be good and metal ions will gradually come down (I know it is a long process, sometimes up to 2 years) than I won’t rush to have another revision surgery. So this is my story.

Dear Earl, what do you think about my decision, do you think I have to do some other checking ups in regards to my problem. I will be glad to sue Smith and Nephew for producing such a horrible device, I have made enquiries in Australia and in one law firm in America but they refused to help me because there is not class action against S&N. So I will wait until many people will come forward and do the same as I want to do. If you know about any possible law suit against Smith and Nephew please let me know.

Looking forward to hear from you soon

Kind regards

Hanna Viner

Mr Robathan, 61 – who has been told he will have to have a double hip replacement, said that although the implants he was fitted with have been recalled, it is ‘more tricky’ to simply recall something that is ‘stuck inside you.’

Table 1: Membership of 2013 panel, their arthroprosthetic company allegiances and their intrarelationships.

Panelist	Arthroprosthetic Company	Nature of compensation	Notes
AV Lombardi (moderator)	Biomet	Royalties, employee or consultant, speaker’s bureau.	President of the Hip Society, metal-­‐on-­‐metal modular hip advocate. Chair of the annual meeting hip program committee. Has collaborated with the other members of the panel on publications and AAOS CME activities related to metal-­‐ metal hips.
MA Mont	Stryker, Wright Medical	Royalties, employee or consultant.	Hip Resurfacing Advocate has resurfaced 1600 hips. Hired gun by Stryker to promote the Corin metal-­‐metal hip resurfacing. Has collaborated with the other members of the panel on publications and AAOS CME activities related to metal-­‐metal hips.
TP Schmalzried	DePuy, Stryker, Wright Medical	Royalties, employee or consultant.	Hip Resurfacing Advocate and design surgeon of the ASR. Has collaborated with the other members of the panel on publications and AAOS CME activities related to metal-­‐metal hips.
JJ Jacobs	Zimmer, Medtronic, Implant Protection	Stock options, employee or consultant.	Wrote some of the foundational literature supporting metal-­‐on-­‐ metal technology with Dr. Schmalzried. President of the AAOS. Has collaborated with the other members of the panel on publications and AAOS CME activities related to metal-­‐metal hips.
Young Min Kwon	None declared.	Past research work supported by multiple arthroprosthetic companies.	Foundational researcher on the periprosthetic complications of chrome cobalt metallosis. Has collaborated with the other members of the panel on publications and AAOS CME activities related to metal-­‐metal hips. Least conXlicted of the faculty.
SJ MacDonald	DePuy, Stryker	Royalties, employee or consultant, research support.	Wrote some of the foundational literature supporting metal-­‐on-­‐ metal technology with JJ Jacobs.

I sincerely apologize for mistaking Dr. Fehring’s arthroprosthetic company allegiance as being Biomet rather than DePuy. DePuy as well as Biomet has a large metal-metal hip liability. DePuy’s ASR has been formally recalled from the market and was implanted in 92,000 patients. DePuy’s Ultramet modular metal-on-metal product is still on the market and is part of DePuy’s popular “Pinnacle” acetabular system. Dr. Fehring has likely assisted DePuy with the development of this product line although he is not the “thought leader” on the metal- metal bearing option. His work with DePuy has likely brought him into close collaboration with Dr. Schmalzried who also consulted on the “Pinnacle” system and was the primary design surgeon of the ill fated ASR. DePuy has already placed a 5 billion dollar down payment on the ASR remediation.The metal-metal option for the “Pinnacle” system appears to have the same problems as the “ASR” and many more have likely been implanted.

I appreciate that Dr. Fehring has recognized and published on the complications of the “ASR” and has also contributed to publications addressing monitoring protocols for patients implanted with metal-metal hips.The Alaskan experience indicates that monitoring criteria developed by Dr. Fehring in collaboration with the other symposium panel members may be more protective of the arthroprosthetic companies from which these surgeons have received millions of dollars than the patients that been implanted with those companies metal-metal hip products.

Experts on Conflict of Interest (COI) in the professions might conclude that only Dr. Kwon is qualified to objectively address the complications of metal-metal hips. He is but one of six, his influence is likely to be muted by the “group-think” of the five more conflicted members.

The weakness of the proposed monitoring criteria of the publications that you reference is that blood cobalt determinations are recommended only for patients with notable symptoms at the hip and the possiblity of the systemic complications of unidentified cobaltemia is minimized. Our experience indicates that all patients with metal-metal hips should be contacted and their blood cobalt levels determined. Patients with blood cobalt levels above10 mcg/L merit a through neurologic and cardiac evaluation. The neurologic and cardiac complications of cobaltemia are insidious, progressive, and potentially disabling. Patients can develop these complications without sentinel hip symptoms.

Most of our severely cobaltemic patients, incuding five with disabling neurologic toxicity, had minimal symptoms at the hip. Two of our toxic patients had no hip symptoms although both had severe periprosthetic tissue damage.

I am concerned that the 2013 symposium on metal-metal hip complications will be a repeat of last year’s. I witnessed that event and found the panel to be hopelessly entangled with industry and unable to adequately recognize or disclose those entanglements.

Table 2: Membership of 2012 panel, their arthroprosthetic company allegiances.

Panelist	Arthroprosthetic Company	Nature of compensation	Notes
WJ Maloney (moderator)	Wright Medical, Zimmer	Royalties from Wright Medical Received $423,412 from Zimmer in 2007	Also does medical legal surgeon and industry defense work.
JJ Jacobs	Zimmer, Medtronic, Implant Protection	Stock options, consulting fees.	Wrote some of the foundational literature supporting metal-­‐on-­‐ metal technology, Vice President of the AAOS.
CA Engh	DePuy	Royalty income in 2010-­‐11 > $ 350,00 Consulting income 2010-­‐11 > $ 27,000	Has resurfaced > 500 hips and did studies initially supportive of DePuy’s modular metal-­‐on-­‐ metal hip.
TP Schmalzried	Design Surgeon ASR, DePuy, Stryker	Royalties from ASR 2010-­‐11 $3.4 million	Has resurfaced > 600 hips. Wrote some of the foundational literature supporting metal-­‐on-­‐ metal technology with JJ Jacobs.
DW Murray	Biomet, DePuy, Smith & Nephew, Stryker, Wright Medical, Zimmer	Royalties from Biomet and Smith &Nephew Research support from all listed	Believes that metal levels are of academic interest and only indicates revision of metal-­‐on-­‐ metal hips for those with major symptoms at the hip.
BL Penenberg	Wright Medical	Consulting fees and Royalties	Involved in the design of Wright Medical’s modular metal-­‐on-­‐ metal

 

I must disagree with your statement that the present process for determining the CME content at the annual meeting is acceptable. The choice of such a commercially conflicted panel to address the largest medical device failure in history points to the contrary. The inclusion of Dr. Schmalzried on multiple panels at this year’s and last year’s meetings seems inappropriate. He is the design surgeon of the ASR and continues to promote and perform metal-metal hip resurfacing. It is extraordinarily unlikely that Dr. Schmalzried could either recognize or reconcile the true frequency, severity, and cost of the periprosthetic and systemic complications of chrome-cobalt metallosis. Placing Dr. Schmalzried on any panel at an orthopedic meeting is akin to a mariners convention featuring the captain of the Costa Concordia as the keynote speaker on the topic of inter-island navigation.

I have similar concerns about the inclusion of Dr. Mont. It seems that much of the purpose of the symposia at the 2012 and 2013 meetings is to reassure surgeons that hip resurfacing remains a viable and safe arthroplasty option. There is no Level 1 evidence that hip resurfacing has advantage over a stemmed metal-on-plastic one that is proven safer, more durable, and less expensive. For the hip program committee to continue to place hip resurfacing advocates at the podium of AAOS CME events is a disservice to marketable surgeons, arthroplasty candidate patients, society, and the million patients already implanted with metal-on-metal hip arthroplasties.

Why would the hip program commitee place commercially conflicted hip resurfacing advocates at the podiums of the world’s most influential orthopedic meeting where they are likely to minimize the periprosthetic and systemic complications of chrome-cobalt metallosis?

Table 3: Membership of 2013 hip program commitee and their arthroprosthetic company allegiances.

Surgeon Committee Member	Arthroprosthetic Company	Nature of compensation	Notes
AV Lombardi (chair)	Biomet	Consulting fees, royalties, and speaker’s bureau.	Also President of the Hip Society, Fellow of GA Engh and TH Mallory. Has published studied supportive of modular metal-­‐on-­‐metal hips with large heads.
KL Garvin	Biomet	Royalties
DW Manning	Biomet	Consulting fees and royalties.
JB Meding	Biomet	Royalties
JW Mesko	Stryker	Consulting fees
DE Padgett	Stryker, Mako	Royalties, consulting fees, stock or stock options.
JC Kudrna	DePuy, Innomed, Convatex	Royalties, consulting fees, stock or stock options.
WB Macaulay	Wright Medical	Research Support	Vocal hip resurfacing advocate has performed > 100 hip resurfacing.
AH Glassman	Zimmer, Stryker, Exatech, Innomed	Royalties, consulting fees, stock or stock options, speakers bureau	Has coauthored multiple papers with CA Engh.
MJ Archibeck	Zimmer		Not declared but DOJ disclosure notes he received 14K from Zimmer in 2006 trained by or is colleague of JJ Jacobs
PE DiCesare			None declared but is on the faculty at HSS and a colleague of Dr. Su a major advocate for Smith and Nephew’s BHR resurfacing.
AJ Ayers
JF Fetto
RH Gonzales
JM Passick

 

It is notable that two-thirds of the hip program committee panel members are financially entangled with arthroprosthetic companies with huge metal-metal hip liabilities.

This committe not only controls the content at hip replacement related symposia and instructional course lectures, it also controls the content of the hip replacement related scientific program.

I submitted applications for the symposium on metal-metal hip complications, an instructional course lecture of the management of the metal-metal hip implanted patient, and three scientific papers on the systemic complications of chrome-cobalt metallosis, the histopathology about failed metal-metal hips, and on the explant analysis of failed metal-metal bearings. These submissions were rejected

by a hip program committee rife with Surgeon Industry Conflict of Interest. I wonder how many other submissions addressing the underappreciated complications of the metal-metal hips might have also be excluded from the program of the 2013 meeting.

I spoke with Dr. David Langton at last years annual meeting. He is arguably the World’s foremost authority on the periprosthetic complications of metal-metal hips. He has also had great difficulty in getting any of his many submissions on metal-metal hip complications accepted for presentation at AAOS annual meetings.

I am worried as much about what will not be presented at this year’s meeting as what will be presented. I agree that not all the members of the selected symposium are dyed in the wool metal-metal hip advocates but they are all entangled with surgeons that are, or with arthroprosthetic companies that might be bankrupted by their metal-metal hip liabilities.

Please forgive my passion in attempting to advocate for the million patients implanted with metal-metal hips and those that might unwittingly be placed at risk due to ongoing hip resurfacing. I am troubled that the million metal-on-metal hip implanted patients that are at risk for asymptomatic periprosthetic tissue loss and an insidious, reversible, and potentially disabling neurologic illness are not being appropriately monitored by their surgeons. This equates to patient abandonment.

Please accept my sincere apology for misindentifing Dr. Fehring’s commercial arthroprosthetic affiliation. It is difficult to keep straight who works for who.

Dr. Jacob’s has generously offered to present my work on arthroprosthetic cobaltism in my stead in two weeks. If this communication seems rushed or contains minor inaccuracies, I apologize, I am preoccupied with interviewing the 24 patients of my series to assertain their present status so that I can supply Dr. Jacobs with a current manuscript on the incidence of cobaltemia and cobaltism in 24 Alaskan patients with 26 revised metal-on- metal hip arthroplasties.

Sincerely,

 

Stephen S. Tower, MD

Fellow AAOS, Affiliate Professor, UAA, WWAMI School or Medicine

Letter from Dr Frick

Dear Dr. Tower,

As Central Program Committee Chair for this year’s AAOS Annual Meeting, I have appreciated your concerns about the processes used to construct our program. Our committee and organization are taking your concerns seriously to strengthen and improve what I believe is already an excellent system, one that produces an annual meeting that provides the best educational experiences in the world for orthopaedic surgeons.

While President Tongue and the Presidential Line speak for the organization, I am responding personally and on behalf of the Program Committee about some of the inaccuracies in your recent letters. Like many passionate individuals trying to effect change, if your message contains information stated as fact that is not true, the rest of your message loses its intended effect.

1.         Beaver WB, Jr., Fehring TK. Abductor dysfunction and related sciatic nerve palsy, a new complication of metal-on-metal arthroplasty. The Journal of arthroplasty. Aug 2012;27(7):1414 e1413-1415.

2.         Kwon YM, Jacobs JJ, MacDonald SJ, Potter HG, Fehring TK, Lombardi AV. Evidence- based understanding of management perils for metal-on-metal hip arthroplasty patients. The Journal of arthroplasty. Sep 2012;27(8 Suppl):20-25.

3.         Steele GD, Fehring TK, Odum SM, Dennos AC, Nadaud MC. Early failure of articular surface replacement XL total hip arthroplasty. The Journal of arthroplasty. Sep 2011;26(6 Suppl):14-18.

4.         Fehring TK, Fehring K, Springer BD, Masonis JL, Dennos AC. Comparative analysis of periarticular osteolysis in modern total hip bearings: a minimum 5-year study. The Orthopedic clinics of North America. Nov 2012;43(5):e14-16.

5.         Griffin WL, Fehring TK, Kudrna JC, et al. Are metal ion levels a useful trigger for surgical intervention? The Journal of arthroplasty. Sep 2012;27(8 Suppl):32-36.

The third surgeon you questioned in your letter is Dr Lombardi.       I do not know Dr. Lombardi personally, but see that he is listed as a coauthor on a paper on the “perils” of metal-metal THA (article #2 above)

Last, you question whether the potential complications of metal-metal THA will be covered in the symposium, and complain that the AAOS is somehow suppressing information about these potential complications to the detriment of patients. Below is the application for the the symposium on metal-metal THA that was selected for presentation at     the 2013 Annual Meeting. Reading this, it is difficult for me to see how this presentation will not address the potential local and systemic complications of metal-metal THA. Also for your information, your symposium on metal-metal THA was not the only other symposium on metal-metal THA that was not selected by the program committee. In fact, President- elect Jacobs also submitted a symposium on metal-metal THA that was not graded as highly as the symposium below, and thus it also was not selected.

Basic Science Consideration: This symposium addresses important issues such as understanding metal-on-metal failure mechanisms, current recommendations, clinical presentation of adverse soft tissue reactions, a systematic diagnostic algorithm, and utility of specialized tests including metal ion levels and cross-sectional imaging studies. Integration of clinical expertise from national faculty with best available clinical evidence from research and national joint registry data into the decision making process to address clinical challenges relevant to every day practice and identify areas for future research.

Learning Objective 1: Understand the spectrum of clinical presentations of adverse soft tissue reactions (symptomatic and asymptomatic), reflecting a complex interplay of implant, surgical and patient factors.

Learning Objective 2: Comprehend the various intrinsic and extrinsic causes of a painful metal-on-metal hip arthroplasty as well as a systematic treatment approach to optimize management based on currently available data.

Learning Objective 3: Recognize a low threshold to perform a systematic evaluation of metal-on-metal patients as early recognition and diagnosis will facilitate initiation of appropriate treatment prior to significant adverse biological reactions.

Learning Objectives All: For Report: Understand the spectrum of clinical presentations of adverse soft tissue reactions (symptomatic and asymptomatic), reflecting a complex interplay of implant, surgical and patient factors; Comprehend the various intrinsic and extrinsic causes of a painful metal-on-metal hip arthroplasty as well as a systematic treatment approach to optimize management based on currently available data; Recognize a low threshold to perform a systematic evaluation of metal-on- metal patients as early recognition and diagnosis will facilitate initiation of appropriate treatment prior to significant adverse biological reactions.

FDA cracks down on all-metal hip replacements

Manufacturers who want to keep selling all-metal hips will have to prove that they’re safe and effective, according to proposed new rules from the Food and Drug Administration. Incredibly, for the past decade manufacturers have been aggressively marketing the devices as being better than conventional varieties without that evidence, to the great harm of patients.

Last year in our report on dangerous medical devices, we highlighted evidence that patients with all-metal artificial hip implants were suffering serious side effects, including pain, infections, muscle lesions, and neurological problems such as depression and deterioration of hearing and eyesight, as a result of reactions to metal debris wearing off their implants. At the end of this blog is a video highlighting one such victim, an Alaska orthopedic surgeon, Dr. Stephen S. Tower, whose research was cited in the the FDA’s announcement.

At the peak of the craze for all-metal hips in 2008, they accounted for about 40 percent of all hip replacements done in the U.S., according to new estimates by Steven M. Kurtz of Drexel University. He estimates about 755,000 Americans have been implanted with the hips. Their use has dropped dramatically in recent years as awareness of their dangers has spread.

The FDA regulations announced yesterday specify that once the new rules become final, likely to happen sometime later this year, manufacturers will have 90 days in which to file applications that include the results of clinical trials and other “valid scientific evidence” showing the hips are safe and effective. If they don’t, they’ll no longer be able to sell them in this country.

“I think it’s a good thing,” Tower told us, “but in a lot of ways it’s a formality, because the use of the devices has practically gone to zero anyway.”

Manufacturers we contacted yesterday said they were still studying the FDA’s proposal. Zimmer, once a major purveyor of the all-metal hips, has stopped selling them in the U.S. because “the demand is reduced so much they’re not commercially viable,” said media spokesman Garry R. Clark.

If you have an all-metal hip, here are symptoms to watch out for, according to the FDA:

• Swelling, numbness, noise (popping, grinding, clicking or squeaking of your hip), and/or a change in ability to walk.
• General hypersensitivity reaction (skin rash)
• Deterioration in your hearing or eyesight.
• Psychological status change (including depression or cognitive impairment)
• Kidney problems
• Thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold)

Anyone who experiences these symptoms should seek medical attention and, in particular, consider tests that detect elevated levels of the toxic metals cobalt and/or chromium in the bloodstream.

Sources
FDA safety communication: metal-on-metal hip implants

Information for patients who have metal-on-metal implants (FDA)