Artificial hips corrode, poisoning some patients, lawsuits say

Published: January 31, 2013

By STACEY SINGER — Palm Beach Post

PALM BEACH, FLA. — Soon after Scott Ebert had his arthritic right hip replaced at 48, he felt so much better he named his new puppy Stryker, after the cool-sounding brand of his hip implant.

But his relief was short-lived.

Two months after surgery, Ebert’s leg started giving way. His joint began slipping. Razor blades of pain pierced his foot. An inexplicably large bruise grew along his calf. An excruciating burning feeling filled his hip. His ears rang. Doctor after doctor didn’t know why. Finally, blood tests showed the metal from Ebert’s artificial hip was leaching into his bloodstream.

Six months after it was installed, Ebert’s new joint had to be replaced. He’s left with chronic pain.

Ebert’s Stryker Rejuvenate hip prosthesis was supposed to have been the latest and greatest, a new modular design fitted perfectly to his anatomy, with a choice of stems to be planted into his thigh bone and a choice of necks to support a choice of artificial balls and sockets.

Instead, Stryker’s Rejuvenate and ABGII modular systems were recalled in July. They are the latest entries in a gallery of recent hip implant product failures, failures that are shining a light on the need for a system that detects quickly when medical devices go wrong.

The failures appear to have metal and friction in common: metal-on-metal balls and sockets, metal-on-metal stems and necks. Friction appears to cause wear that exposes bare metal to blood and nearby tissues. These traveling metal ions can promote inflammation, tumor-like swellings and muscle and bone degradation, according to physicians and research reports.

An FDA panel last summer found almost no good reason to use metal-on-metal hip implants after reviewing 17,000 reports of problems in about 500,000 patients with metal balls and sockets. On Jan. 9, Stryker told shareholders it expects the recall to cost it between $190 million and $390 million.

“We have been through a rash in recent years of all these device failures,” said Boynton Beach, Fla., orthopedic surgeon Dr. Gregory Martin. “All the implant companies, when it first happens, say, ‘Oh, it’s just their problem.’ Then we come to realize that certain people don’t react well to the wear particles.”

For a generation of baby boomers growing old and arthritic, total hip replacement is an increasingly common need. More than 1 million of the procedures are performed in the United States every year, and the number is projected to quadruple by 2030, propelled by the graying and fattening of America. Charges can run $50,000 or more per procedure in Florida.

Research shows that for patients with severe hip arthritis, joint replacement can improve quality of life and reduce pain. More than 90 percent of new hip recipients still have their artificial joints after 10 years, the industry reports. But consumers and their doctors alike are still unclear about which materials and surgical techniques are best. Lack of data leaves marketing campaigns and paid surgeon-consultants to tout their ideas.

Modular hip joints, with their interchangeable parts, were supposed to be a design improvement on one-piece devices, allowing for a better fit, especially for more active, younger patients. Stryker and many other joint manufacturers used alloys of titanium and chromium cobalt to combine flexibility with strength, while avoiding the breakage seen in titanium-only stems.

But the combination instead seems to have led to microscopic cracks and wear at the neck early in the life of the Stryker joint. In a notice to surgeons, Stryker used the terms “corrosion and fretting.” Tiny metal ions disperse into nearby tissues. In some patients, it appears these metal wear particles cause severe inflammation and pain, and over the long term, there is a concern they could cause cancer, studies show.

Boca Raton, Fla., retiree Dianne Pingel, 66, used to exercise at the YMCA and go for long walks with her husband. Now, she said she is lucky to walk to the mailbox.

She is recovering from five surgeries related to hip implants in succession. Her left hip was replaced in July 2011 with a Stryker Rejuvenate modular stem. Her right hip was replaced 14 weeks later, in October, also with a Rejuvenate device. The right one has since been removed, but the left hip device remains. It needs to come out.

Pingel’s blood cobalt levels are abnormally high and MRIs show a tumorlike swelling on the remaining Stryker hip, something that had happened with the removed joint, according to a lawsuit she has filed against Stryker. She said she should’ve gone into surgery right away, but her doctors told her she wasn’t well enough. Her surgery is now scheduled for Feb. 4. Her right leg had to be rebuilt by a trauma surgeon last summer after her first revision surgery went badly.

Removing an existing artificial hip and putting in another one is much more extensive than a first hip replacement. It requires a larger incision, and the sawing away of significantly more bone. Surgeons are forced to pull out a device often firmly cemented into what’s left of the patient’s femur, attempting to minimize damage to what bone is still there. If the problem joint is surrounded by dead muscle and tissue, that must be removed, too.

Pingel’s thigh bone broke during her revision surgery. With so much tissue loss, her artificial hip dislocated repeatedly. A series of new femur fractures erupted. Her surgeon told her the cobalt poisoning and surrounding tissue destruction caused bone to die. A titanium rod now supports her right leg. Basic movements like putting on shoes, using stairs or simply using a public restroom are extremely difficult, she said.

“I just never thought this is how I would have spent my first year of retirement, in and out of hospitals,” Pingel said. “It’s a lot for a person to go through.”

She’s angry with the manufacturer.

“They have jeopardized a lot of people,” she said.

The Stryker modular hips were cleared for market in February 2009. By April 2012, the company was notifying surgeons of the risk of corrosion. Recalls in Canada and then the United States followed.

Pingel is the first Rejuvenate patient in the nation to sue Stryker, but she’s hardly the last. She and Ebert are both represented by West Palm Beach attorney C. Calvin Warriner at Searcy Denny Scarola Barnhart & Shipley. Pingel’s suit is one of nine that have been filed in Bergen County, N.J., where Stryker is based. The company, in its court response, denied the allegations. A company spokeswoman had little to add.

“As a matter of company policy, we don’t comment on legal matters,” said Stryker’s Jeanine Guilfoyle.

Since taking Pingel’s case, the attorneys have added 300 clients, Warriner said.

Warriner blames the product recalls on two factors: First, an approval process at the U.S. Food and Drug Administration that allows new medical devices into the market with minimal testing if they claim to be improvements on already approved devices. And second, government’s lack of an independent and transparent system for tracking medical devices.

“What we need is a national device registry. They have it in Australia and Europe. Every single device implanted in a patient gets listed in a registry and they track these devices,” Warriner said. “It is embarrassing that a country as advanced as ours doesn’t have that.”

The problems with Stryker’s Rejuvenate and ABGII modular hip joints were revealed first not in the United States, where at least 20,000 were implanted over almost three years, but in Australia, where far fewer were implanted.

Australia picked up the problems first because of its national joint replacement registry, said Dr. Art Sedrakyan, director of the Comparative Effectiveness Research Program at Weill Cornell Medical College’s Public Health Department in New York. Sedrakyan served on the FDA panel that reviewed metal-on-metal joints.

“We really need that large data capture system that goes back to regulatory agencies,” Sedrakyan said. “Without information, we cannot inform patients.”

A national joint registry could enable doctors to know with certainty that they were matching the right type of prosthesis to the appropriate patient because they could sort data based on patient characteristics. They could then assess product life and revision rates for their type of patient. Regulatory agencies such as the FDA could move quickly when problems arose. And it would cover not just artificial hips, but knees and other joints, too.

Now, the FDA asks companies to track their products and report back. But there is a lag time, and it’s unclear what the failure rate is, because the data doesn’t include the total number sold.

Medical device makers argue that a voluntary product registry is the right approach. The American Academy of Orthopedic Surgeons has given seed money to launch a nonprofit, the American Joint Replacement Registry.

The voluntary registry’s executive director said the goal is to create the largest registry in the world, one similar to Australia’s mandatory system. But the project has been thwarted by the lack of a uniform method for hospitals to scan data, such as a bar code. Instead, hospitals must assign a staff person to enter data. In 18 months, 116 hospitals have agreed to participate. The group hopes to attract more than 3,000. In addition, device makers need to develop a plan for adding serial numbers to actual devices without increasing risk of corrosion or metal exposure.

“Everybody says, ‘Why haven’t we done this in the past?’ But really technology is just being brought up to speed where we can do it,” said Jeffrey Knezovich, executive director of the Rosemont, Ill.-based registry.

Faced with a barrage of liability lawsuits, Stryker isn’t saying what percentage of its joints have failed.

“Our decisions are based on evaluation of post-market surveillance data,” Guilfoyle said in an emailed response to questions.

Boynton Beach retiree Branko Obradovic, 73, is also suing Stryker through Warriner. One of the facts that bothers him is his first surgeon’s relationship with the company.

Dr. Robert B. Zann is listed as a consultant to the firm, a fact Obradovic said he didn’t know. Company records show Zann was paid in the range of $225,000 to $250,000 for his consulting services in 2011, before the modular joint recall, plus between $25,000 and $50,000 for other services and less than $25,000 for research services.

Stryker’s spokeswoman would not reveal the nature or length of Zann’s consulting arrangement other than to confirm that there is no exclusivity requirement, and “absolutely no requirement for our consultants to use or refer others to use any Stryker products.”

Zann did not return repeated calls requesting comment.

Stryker was one of five companies cited by the U.S. Department of Justice for having improper consulting arrangements with physicians in 2007. Stryker agreed to a monitoring program, and it was deemed compliant in 2009.

Obradovic asked another surgeon, Dr. Gregory Martin, to do the second revision surgery. He said he’s doing somewhat better now that the joint is out, although he still suffers pain if he stays in one position too long, and he suspects the effects of cobalt poisoning are lingering.

“I’m very angry about the whole thing,” he said. “They should know what they are putting in someone’s body.”

Ebert also was a patient of Zann’s. He said it took Zann months to accept his complaints of slippage and pain and order a cobalt test. The cobalt test showed his joint was failing. When his surgeons finally opened his leg up, they found dead muscle tissue around the joint, and fluid-filled tumor-like growths. He said Zann apologized to him afterward for not listening sooner.

Ebert of Deerfield Beach, Fla., believes his case may have been the one that caused the company to finally take its problematic joint off the market, because Zann told him he sat a company executive down over dinner and told him the modular joints needed to be recalled. Stryker issued its product warning two weeks after Ebert’s revision surgery, and the recall came shortly after Zann’s dinner, which was over Father’s Day weekend, Ebert said.

“It has totally ruined my life,” said Ebert, a master automotive mechanic who works on semitrailer-tractor rigs. “I got pain in my leg all the time, my leg always gives out. I used to run all the time. I can’t run. I can’t play with my dog anymore.”

Ebert’s wife, Molly, pleads for answers about what to do now, because her husband’s pain is still extreme.

“Who is working on this or finding out how to fix my husband and all of these other people who had the misfortune to get this hip?” Molly Ebert asked. “It’s very disconcerting to hear your doctor say, ‘I don’t know.’ We’ve gone to the Cleveland Clinic, Holy Cross, seen specialists. No one can give us any answers. I’m frightened for my husband.”

RECENT PROSTHETIC HIP RECALLS

The FDA encourages patients who have metal-on-metal hip replacements to follow up with their surgeons and seek regular blood tests.

2008 – Zimmer Durom Acetabular Component (“Durom Cup”) label recall, because of surgical technique instruction issues. On the market with updated instructions, but, according to a company spokesman, no longer for sale in the United States due to lack of demand.

2010 – DePuy ASR Total Hip System, because of higher-than-anticipated revision rates according to non-U.S. joint registries. Off the market.

2012 – Stryker Rejuvenate and ABGII modular neck-stems because of corrosion. Off the market.

2012 – DePuy Orthopaedics unused custom hip and knee replacement implants; a warning letter from the FDA said that they had not been properly approved for use in patients, DePuy disagreed. Off the market.

Source: FDA/DePuy/Zimmer

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Orthopaedics Today Europe, Issue 6

MANCHESTER — Surgeons can use MRI and ultrasound equipment to detect metallosis in potential metal-on-metal total hip replacement revision patients, but researchers from the United Kingdom have recommended taking patient symptoms into consideration as well, according to a recent presentation.

“Although ultrasound and MRI are useful in the treating of metal-on-metal patients, there is a significant percentage of hips that have pain with negative radiology findings,” Naveed Ahmed, MBBS, MSc, of Prince Charles Hospital in Merthyr Tydfil, United Kingdom, stated in his presentation at the British Orthopaedic Association Congress, here.

Ahmed and colleagues retrospectively examined imaging results from 25 hips (16 patients) between March 2011 and May 2012: 23 hips had ultrasound scans and 21 of these hips also had MRI scans preoperatively. The patients’ average age range was 37 years to 69 years. Ultrasound was done an average of 50 months after primary total hip replacement. The MRI and ultrasounds were reported by musculoskeletal radiologists. All patients had blood tests for cobalt and chromium levels, Ahmed said.

“During surgery, multiple samples were taken from the acetabulum, capsule, as well as tissue lining the femoral neck and sent for histopathology,” he said.

The researchers analyzed fluid collected from patients during revision surgery for evidence of metallosis. MRIs were positive for fluid collection in 16 patients, while ultrasound was positive in 18 patients.

Four patients had both negative MRI and ultrasound results, but were still revised due to pain and were found to have “histopathology positive metallosis,” according to Ahmed. The histopathologist involved in the study defined metallosis as the “presence of sheets of macrophages with dark brown pigmentation in the cytoplasm under polarized light,” Ahmed said. One patient had a positive ultrasound and negative MRI result; similarly, one patient had a positive MRI with a normal ultrasound, he said.

“MRI and ultrasound are useful in screening of hips with metal-on-metal arthroplasty,” Ahmed told Orthopaedics Today Europe. “Still there are a significant percentage of hips which have failed with negative radiology findings.” – by Jeff Craven

Reference:

Ahmed N. Paper #20. Presented at: British Orthopaedic Association Congress; Sept 11-14, 2012; Manchester.

For more information:

Naveed Ahmed, MBBS, MSc, can be reached at Gurnos Rd., Merthyr Tydfil CF47 9DT, United Kingdom; email: drnaveed75@yahoo.com.
Disclosure: Ahmed has no relevant financial disclosures.

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Metallosis-induced Iliopsoas Bursal Cyst Causing Venous Obstruction and Lower-limb Swelling After Metal-on-metal THA

Abdulrahman D. Algarni, MD, SSC(Ortho), ABOS; Olga L. Huk, MD, MSc, FRCS(C); Manuela Pelmus, MD, PhD, FRCP(C)

Abstract

The formation of iliopsoas bursal cystic lesions after total hip arthroplasty is an infrequently reported condition. This article describes an unusual complication of a current-generation metal-on-metal total hip arthroplasty.

A woman presented with unilateral spontaneous lower-limb swelling that developed 5 years postoperatively. It occurred secondary to venous obstruction by a metallosis-induced iliopsoas bursal cyst associated with markedly elevated intralesional cobalt and chromium levels. Metal artifact reduction sequence magnetic resonance imaging showed that the bursal cyst was communicating with the hip joint and that it severely compressed the common femoral vein. Based on the findings of high local tissue metal ions and vertical cup positioning causing edge loading, the authors proposed an inflammatory reaction to metal debris that tracked into the iliopsoas bursa and formed a cyst. The patient underwent revision of the excessively vertical acetabular component and conversion to a ceramic-on-ceramic bearing interface, drainage of the bursal cyst, and synovectomy. No signs existed of local recurrence at 1-year follow-up.

To the authors’ knowledge, the occurrence of metallosis-induced iliopsoas bursitis with secondary pressure effects after contemporary metal-on-metal total hip arthroplasty has not been reported. When treating hip dysplasia, one must avoid maximizing cup–host bone contact at the risk of oververticalization. Iliopsoas bursal cystic lesions can lead to severe vascular compressive symptoms with no ominous radiographic findings. Physicians and orthopedic surgeons should be aware of the possibility of this complication in patients with unexplained unilateral lower-limb swelling.

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December 9, 2012, 10:30:00AM. By Jane Mundy

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 by Stuart Cain, DePuy Victim, Brisbane, QLD, Australia

As I sit here in Australia after my 5^th surgery in 5 years, I was amazed and more than a little surprised to learn recently that despite the on-going court cases against Johnson & Johnson/DePuy, that they had attempted to contact we the patient group and offer a “Compensation Programme” in relation to pain and suffering! On first reading I thought finally, but on closer inspection all was not as it seemed, so I wanted to give all of you a few things to consider, especially if you are considering participating in this “Programme”.

Firstly, I am not a lawyer and I thoroughly recommend that before you do anything that you consult one, however I am an ASR hip patient who has been irreversibly damaged by this implant who also just happens to be a health professional. Whilst much of the legal spotlight is currently on Johnson & Johnson/DePuy, I assure you that with recent developments here in Australia (the TGA has officially announced a recall/Alert around the Birmingham Hip Modular Head – used in hip replacement, due to high revision rates as recorded by the NJRR. Source: TGA Update Tuesday 6 November 2012), that many of you who have other MOM hip implants will hopefully soon be having to consider these very same issues. Being involved in a class action can be daunting, confusing and at times over-whelming, however it doesn’t matter if you are chasing Johnson & Johnson/DePuy, Smith and Nephew or any other manufacturer, you need to consider a great number of things that in some cases the lawyers will either overlook and the companies that you are going to challenge certainly won’t bend over backwards to tell you or advise you on.

You will be asked to consider what you have gone through. This will include the obvious questions of financial loss, whether it be from not being able to work, expenses incurred as part of your medical treatment or other related costs. You will be asked to put a price on your ‘pain and suffering’, I challenge anyone to easily do that! I will also be surprised if many lawyers have the magic formula for working this out either! However you will, in your own way and taking into account exactly what you have been through and suffered have to try to do this, it is very individual and I am not arrogant enough to even try to tell you how to go about it, you have to work this out according to your own experiences, don’t let anyone tell you otherwise. What I will tell you is that you should consider not just what it has cost you physically, emotionally and psychologically, but also remember what it has done to your loved ones as well, they have often ‘lived’ this experience with you in just as damaging a way. It is also very important that you can ‘demonstrate’ what you have gone through, whilst this is very difficult when talking about pain, I recommend the use of a diary or at the very least write down what your life used to be like and what it is like now and then compare! I think if you take the time to do this you will be shocked as I was! A good lawyer will advise you on your rights in considering what has occurred from the point of receiving the suspect hip up until the present day so I won’t focus too much more on that.

What I do want each of you to really take notice of, especially as DePuy suggested that in their ‘compensation programme’ that they were going to merely separate those interested into 2 categories (one who had achieved a ‘good result’ and one whose experiences were ‘more involved’, for want of better words), is that this is where the medical device companies (and sadly some law firms) lose sight of some truths about our situations. REMEMBER: There has been very little research into the true impact of the release of Cobalt and Chrommium Ions within the Human Body, this is vital because even if you appear to be doing well post revision surgery if needed or even without revision surgery as is the case with some, you still don’t know what the Cobalt or Chrommium you have been exposed to is really doing inside you!! I refer everyone back to the recent post where Dr Tony Nargol says in his video about the ‘well’ patients (symptom free) who returned for check-ups, with consequently high Cobalt levels and on surgical examination had suffered bone/tissue loss and evidence of the damage that those of us who’s hips have catastrophically failed also had. I have met and spoken to some amazing people through this experience, and I would hesitate to guess that as many of us have dealt with levels of pain for many years and some also have other chronic health conditions, that you may well be having symptoms but as you are so used to ‘dealing with it’, that you simply don’t notice them. I urge everyone to never lose sight of the fact that we have all been poisoned, no-one can categorically confirm if this will EVER properly clear out of our systems and the net result of that is that even if you feel well today, tomorrow is another thing all together, as is the next day etc. I am not a negative person, but unfortunately after 5 surgeries, and I know there are many more of you out there who have had more, I still see the effects of Cobalt in my life every day. You have to consider this when looking at compensation, I would be very interested to hear from any doctors or researchers who can explain what Cobalt and Chrommium will end up doing as I would appreciate the ‘peace of mind’, however from my experience no-one can provide that information as there has been so little research into it.

There is no second chance once you have accepted a compensation payment/package! I urge you to very carefully consider this! If something goes wrong the day after you have accepted a payout, the company whom you sued is no longer responsible and they won’t have any compassion what so ever! If you have been through your surgery/s and everything seems to be going well, you may be vulnerable to ‘forgetting or over-looking’ this fact. I must admit that I didn’t really understand what it would cost until my wife sat down one day and worked out what it would cost in ‘the worst case scenario’! You have to consider your age. At 43, I have been told that I will have to have at least 2-3 more hip replacements in a normal life expectancy (that is considering that the current one actually lasts!). These surgeries and associated costs can reach up to $100,000 each here in Australia and that figure is rounded out and not including complications. My private health fund has already notified me that I won’t be covered for my hip once a settlement is reached so that starts the calculator ticking (if you were waiting in our public system for such surgery depending on what state you are in, you may wait up to 18 months). This is also not taking into account any other surgeries or medical treatment that arises as a result of your MOM hip, MRI’s cost $500 a piece usually, Pathology tests for Cobalt levels in Qld cost $135 per test (I have to have one every 4 months because even without my MOM hip I still get high readings), a night in ICU can cost you $2500-$3000, a regular hospital bed can cost $1500-$1800, average specialist consultation is $150-$200 per visit, medications which could cost $1000’s per year and the calculator is really starting to tick over!

If you end up with decreased mobility or in a wheelchair, a good electric wheelchair can cost up to $10,000, what modifications would you have to make to your home or car, would you need a lift in your house which could cost between $50,000 and $100,000 depending on the property, would you need a new home or car? I have recently been refused travel insurance if I wanted to travel overseas because of “my unpredictable health condition”. I know many of the people I have spoken to would have great difficulty travelling in an ‘economy’ seat if they flew any distance, the cost of ‘business class’ travel is in most cases 3-4 times more expensive. The expenses don’t stop there, try getting any form of insurance, I was advised that I ‘should have lied when I applied’ (I told them I had Arthritis in my hip) when I was recently refused cover by my income protection insurer because I haven’t been able to work as a result of hip surgeries that aren’t even my fault! I nearly forgot, what future earnings will you miss out on? If you are unable to return to your previous employment/profession after your surgery/s, you are eligible to claim compensation for this. I challenge you to sit down and work out if you had to stop work tomorrow, how much would you earn if you worked to 65, just work it out on your current income, I think you will be surprised what that adds up to. Remember, unfortunately this could happen and should be a part of your consideration.

Lifestyle loss in the future is very hard to quantify, but give this a try. Did you have any hobbies, sports or pastimes that you can no longer safely or physically participate in because of your health experiences? Did you want to travel with your partner, maybe you enjoyed hiking or simply as my wife and I used to enjoy, going somewhere new and exploring it on foot! Maybe you liked the surf or the beach and this is no longer possible? Riding horses, motor bikes, jetskis, or any other outdoor activities like sports of any sort, I have even spoken to elderly patients who no longer can participate in their local lawn bowls club. All of this has a price that has to be considered because it has been taken from you!

Finally as part of this I want you to consider the ‘hidden damage’ of what has happened to you emotionally and psychologically and how this will affect your future. I don’t think I have met one single person who can honestly say that this whole experience hasn’t negatively affected them, their loved ones and their relationships with others. This is a cost I can’t put a figure too, you will have to come up with that yourself depending on your experience and what this has done to your potential future life.

Finally, each individual must try to take into account their own circumstances, don’t let anyone try to ‘categorise’ you! We are all different, at varying stages of life and have experienced many things that at the end of the day weren’t of our doing. Many of us will continue to experience the effects of these implants for the rest of our lives, tragically some have already suffered the ultimate ‘complications’ that have dramatically shortened or even taken their lives! Please take this into consideration and don’t be afraid to ask questions, as I have always said if you aren’t satisfied with the answers seek them somewhere else! Just like seeking a second opinion from a doctor if you don’t believe you are getting appropriate answers and care where you are. One thing I have really learned through this experience is that there are a number of people who feel that they may have something to lose by being honest, don’t let anyone treat you as if this is ‘your problem’ and stand up for your rights!

I hope that this sparks some debate and I welcome any and all opinions or questions, as I said I am no expert, but I do believe that we have to stand up for ourselves in this and I will always be willing to take a stand for anyone who feels that they have already suffered enough through this! My best wishes to all the patients out there, my hip brothers and sisters and their loved ones!

Stuart Cain

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I had my left hip total in Germany Jan 2002 and it does what it says on the packet, therefore I had one to compare with when I had a BHR on my right in Jan 2006 and it was never right.

My revision to ceramic was in July 2010 and I continue to have the massive pain in the groin, hip area  and buttock as pre-revision surgery. This has now given me back problems due to distribution of weight and, like everyone, fatigue etc.

Luckily my GP is great and has asked me to send my research to her for her to learn.  I am now on fake morphine patches, gaberpentine, neproxine and amitriptylne and get about 80% pain relief and the pain clinic at my hospital have told me it’s for life.

Not giving in I discovered a surgeon who has great interest in metal on metal hips, Jeremy Latham based in Southampton.  Indeed they are just establishing a special unit for revision hip surgery with an emphasis on mom problems and are incorporating cell biologists, nucular medicine, in fact all the ‘ologies’.  They have been given a huge grant and are associated with Southampton University.

My GP has referred me there (I live in Hastings and it takes 3 hours each way) and they have accepted me as a patient and have asked if I will be a Patient Advocate.  It has recently been discovered that there is,or can be, a reoccurance of the soft tissue reaction post revision surgery.  Southampton where aware of this.

My original hospital University College London were not!!! And they told me they are still using mom implants.  I was speechless.

Southampton were honest in saying that ‘they don’t know’ but my reason for being with them was being in the loop as and when, and if, they ever find a solution.  If you can go to Southampton at least they are honest and will give you the proper tests.

I had never had a blood ion test nor a MARS MRI I have now and have faith that the ‘reader’ of the results will have a better understanding although the surgeon did tell me that things might not show up.  I prefer this honesty and at least they are positively looking for answers.

If anyone wants more info or details email me on gblanch@onetel.com

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I had a revision hip replacement due to high level of metals ie cobalt and chromium 10th August 2011 after several years of feeling very poorly.

I have experienced some debilitating symptons which have completely altered my quality of life, including thyroid problems,nausea, fatigue, headaches muscle and joint pains, breathing problems, poor memory and anxiety and sleeplessness…

In fact I was beginning to think I going crazy after countless visits to my GP who said I was depressed and hyperventilating.

I knew I was not depressed just very very sad at feeling so ill. He recently refered me to a rheumatologist and I have undergone tests. I am waiting for the results which may take another few weeks to get ..

I am very frustrated and scared, feel alone. In spite of having a have a wonderful family and a new grandson who I would like to delight in but due to my health issues am unable.. I do not want to worry them with my real concerns.

I came across this site by default today, as I am trying to find answers help and support.

I want to thank Dr Micheal McCabe for such articulate and understandable words and it seems I am not soo alone..

I would like to speak to other people who feel like me and have had similar experience. It seems impossible to find a forum in the UK. Everything is shrouded in complexities.

Also maybe I am not as computer literate as I could be. It is really difficult to get people to listen especially when you sometimes dont have the energy to talk let alone describe how things really are affecting you.

Anyway thank you for this opportunity to write. I am not even sure where my words will land !!!!

kind regards

Stephanie

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Had a Mitch Stryker total hip replacement , metal on metal, implanted October 2007 at age 43, I have led a very active sporting life and the replacement was needed as a result, i presume, my right hip was diagnosed as arthritic.

As a result of the operation I developed nerve damage and basically had a “dead leg” from the hip down, the resulting “drop foot”, and muscle wastage,made life even more difficult than It needed to be.

After the long periods of “lows” I encountered, and nerve pain which I couldn’t ease, fast forward 18 months, a course of time, of new determination and belief, enabled me to progress to returning to work on light duties initially, then full time, in my role as a Police Officer. The nerve damage had not repaired and rejuvenated fully, but sufficiently enough to allow me to complete all day to day activities.

( I had kept active leading up to the operation, being a keen member of the local cycle club i kept riding to help myself get through and recover well, so I thought at the time. The Surgeon later told me that the nerve was either bruised or stretched during the surgery, due to me being heavily muscled, the nerve damage may well have occurred during the traction stage as I was not as supple as say an “older” person. Either way I got it, a 1% chance!)

So, at two years post op I tried to “ignore”, and not believe that a pain I began to feel in my groin region, then hip region, was actually that “pain” that was all too familiar from the past. I said nothing, not even to my wife, I did not want to believe that this horrible chapter was trying to reintroduce itself to me. It was not long before my wife was on my case, she doesn’t miss much, she had me booking in to see our GP and the surgeon again. Our GP believed quality of life was important and recommended voltaren, – (diclofenac), to assist with the pain, the surgeon after xrays which showed no abnormalities offered that it was possibly soft tissue rubbing, and we would monitor it but also recommended diclofenac to help.

The diclofenac took the edge off the hip pain and I managed to do all that I needed to do.

So, 2011, still taking diclofenac, pain ever present, beginning to get worse. Finding it hard to sleep again, hard to find a comfortable position, pillow between legs again, tossing, turning, irritable with family (4 sons), and workmates, public, back to surgeon, blood tests, xrays, ultrasound etc.

Fast forward 13 April 2012, media announces recall of MITCH THR devices 2006-2010 with a high failure rate I am fortunate enough to be one of only 41 cases in New Zealand! (winner again). Coincidentally my surgeon makes contact to inform me of the announcement, and plan of attack. Do I want it out straight away ? or do we due further tests and get a better “picture” ??

Well, after the 1st operation, I thought, as he did, further blood tests, ultrasound, and MRI scans would give a better picture. My wife and mother n law, thought otherwise.
Ultrasound showed fluid, not good, blood tests showed one metal level high and other low, (chromium/cobalt), literature supplied by Stryker according to surgeon did not put me in the “must operate column”, GP later agreed, basically the metal in blood levels were not elevated enough, so next, MRI booking.

Changes began happening, my ears kept ringing, and ringing, annoying, a rash on my forearm, persistent, GP’s prescribed cream would not cure, pain in finger an “itchy” type pain, last a few days then move to another finger, my focus on small print, hard to read, do I need glasses, maybe just old age? Hip area becoming noticably more sore, then, my upper thigh was noticably bigger than the other, by over an inch! It had swelled, now I was worried!!

August 2012, Back to the surgeon again, yes it is swollen, referred to an “Expert” in Auckland, one of the best in field, “You have an infection in hip due to initial op in 2007″ explains procedure, – 2 operations, 6 months recovery, worst case scenario explained to me , hit with a sledgehammer!! then had a 6 hour drive back home.

Next day my surgeon arranges extraction of fluid via ultrasound from region of my “pseudo tumor”, as recommended by expert, fortunately cultures show no infection initially, but very high “reaction”. A week later I am in theatre, revision surgery to remove “problem”, and, two thirds of my abductor muscle, and 15% of quad muscle, due to metallosis and reaction, went with it. Operation took over 5 an half hours due to tissue damage.

I now have a ceramic ball and plastic cup, and at week 11 post op, I am getting around ok doing lots of physio and pool work. I am not back at work yet, that is still a wait and see. I no longer take diclofenac, for that I am pleased, however the pain/itch in fingers is still there, moved to other hand now, ringing is persistent as ever, eyes have not improved, rash is still there, still irritable, but pseudo tumor has decreased in size. Due to see surgeon again next week, week 12, hoping for good news, one of my concerns is the original stem was not deemed a problem so was left in, I look to the future and “hope” for the best, I am told the metal works its way out of your system in time, and now the “problem” has been removed I can only hope.

I was impressed with the research you had done Earl, and feel “akin” to you, as we share common ground. In retrospect I feel that things may have been different for me with the information I now know. I hope someone else may get something out of my brief summary of my last 5 years with metal on metal.

(my wife commented to the surgeon back in 2007, “surely metal on metal will rub together with friction, will it not?) What would my wife know? I love her dearly.

But alas, in 2007 they were the “best” available for “active” “young” people, the best technology could offer, the rest is history..

Regards, Ropata.

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Imaging, patient symptoms should be considered before metal-on-metal THR revisions

October 19, 2012

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