Procedures: BRAIN CT

07/03/2012
I had the brain CT with iodixanol (contrast agent) today.

The report is as follows:
[MR BRAIN PRE & POST CONTRAST
Technique : Standard brain with diffusion and pre and post contrast and slight imaging of the pituitary gland.
Findings :
Brain anatomy is normal.
No pituitary mass is seen.
Linear T1 hypo / T2 hyperintense focus anterior to the neurohypophysis of uncertain significance. This does not have the appearance of a neoplasm or the shape of a cyst.
Brain parenchymal signal is normal.
There is no intracranial mass, hydrocephalus or midline shift. No abnormal parenchymal or meningeal enhancement is seen.
The craniocervical junction is normal. The intracranial vascular flow voids are normal.
There is a mucosal cyst anterior to the adenoid within the nasopharynx most likely representing a mucous retention cyst.
COMMENT
No pituitary mass or brain abnormality is seen.]

So there we have all. Diagnostic done. I have done EVERYTHING I possibly can.

Procedures: X-RAY

This X-Ray was taken 6 weeks post-resurfacing. The placement is good.

05/03/2012
The surgeon who will doing my revision, said that there may be slight loosening of the femoral component.
Nothing can be confirmed until they open me up!

Research: METAL SENSITIVITY AS CAUSE OF HIP PAIN

Metal Sensitivity as a Cause of Groin Pain in Metal-on-Metal Hip Resurfacing
The Journal of Arthroplasty
Volume 23, Issue 7, October 2008, Pages 1080–1085
We describe 4 patients pooled from our patient populations who presented with groin pain at different periods postoperatively after implantation of a metal-on-metal hip resurfacing. Each patient underwent exploratory surgery after radiographic imaging, hematologic testing, and microbiological assessment of joint aspirations failed to explain their symptoms. Samples of periprosthetic tissues revealed extensive amounts of lymphocytic infiltrates that were suggestive of an immunologic reaction. The patients obtained complete resolution of symptoms subsequent to revision surgery. The incidence of implant failures resulting from metal sensitivity is unknown owing to the difficulty in making a confirmed diagnosis. The possibility that this is the source of groin pain should be considered when other reasons for symptoms of pain and/or joint effusion in hips with metal-on-metal resurfacing arthroplasties have been discounted.

Procedures: REVISION SURGERY

Unfortunately, once resurfacing has been done once, you cannot go back and change the prosthesis and have another resurfacing. The only option is a total hip replacement.
Obviously I am devastated. I went into this being told that resurfacing would last me at least 15 - 20 years. It has  only been 18 months and I need to undergo a total hip replacement.
Usually you would return to the surgeon who did the first surgery, to do the revision, but I cannot as I have issues with the way his practice handled the recall.

Finding the Right Surgeon to do the Revision
05/03/2012
My husband makes numerous phone calls and is determined to find an expert on revision surgery. We strike lucky and find a surgeon in the area who specializes in revision surgery. He fits me in the same day and I feel like there is some hope. His credentials are impressive. He has a special interest in hip revision surgery. He has an MBChB (UCT), an FRCS (Eng) and an FCOrth (SA). He did a knee and an advanced hip fellowship in Bristol, UK in 2004. He has a number of papers published in peer review journals and has presented widely. All boxes ticked.

Here are some points as to why this new surgeon impressed me:
1) He took considerable amount of time studying my X-Ray, MRI and various tests, before he called me in.
2) He was empathetic, yet composed, and sure of himself. I trust him.
3) He did a THOROUGH examination of my hip - different angles, movements, pressure etc.
4) He listened to ALL my concerns and symptoms, and I felt that he genuinely understood.
5) He knew about the developments in MRI protocols and explained what what going on with my MRI. He showed me the images and we talked through all of it.
6) He spent some time on my X-Ray, and confirmed definite loosening of the femoral component. [I was amazed that no-one else had seen this?]
7) He was knowledgeable on metal toxicity and its systemic effects.
8) He had considerable experience with revision surgeries, as well as resurfacing. He said that he stopped doing resurfacing 3 years ago, when he had heard about the high failure rates of the ASR and others. He was a fan of the BHR and I was too.
After considerable discussion, I decide to go ahead with revision surgery. My surgery is booked for Tuesday 13th March 2012.

Orthopedic Surgeon #3

Prosthesis Options

05/03/2012

My surgeon discussed my options with me, and has selected the design of the hip replacement and size of femoral ball to give me the range of motion and stability that I need to function. I have 2 choices of hip prosthesis to consider, each using varying materials and having different pros and cons:

1. Ceramic Ball and Ceramic Liner

I will be taking the Smith & Nephew Ceramic prosthesis. In Pink .

Ceramic is the 21st century answer to hip replacement as it is both hard and durable, it wears minimally and the material is widely deemed to have no toxic or side effects in the human body. Because I am a very active and still young, my surgeon has recommended an all-ceramic hip joint. Ceramic-on-Ceramic is a good combination with longevity and reliability.

There has been a history of two issues with ceramic hips: catastrophic shattering and squeaking. Shattering was more of an issue in the 1980′s and 1990′s but the product has been substantially improved since then, essentially eradicating the shattering problem. Squeaking, however, remains a bit of a problem for a few patients. Often the noises abate over time but sometimes they don’t. If the squeaking is intolerable, a revision may be necessary.

Ceramic is the hardest implant material used in the body, and has the lowest wear rate of all, to almost immeasurable amounts. Consequently, there is usually no inflammation or bone loss, nor systemic distribution of wear products in the body. New ceramics offer improved strength and more versatile sizing options.This is first prize. If this won't work, my second option is metal ball and polyethylene liner.

2. Oxidized Zirconium

Because of its durability and performance, Metal-on-Polyethylene has been the leading artificial hip component material chosen by surgeons since hip replacement surgeries were first been performed. It is also the least expensive bearing.
OXINIUM material has no detectable nickel content. Compared to the traditional metal used in hip implants, the zirconium and niobium contained in OXINIUM material are more biocompatible. This makes OXINIUM heads an appropriate choice for patients with metal sensitivities. Whether it’s metal sensitivity or metal ions you are concerned about, OXINIUM heads on XLPE liners address both of these issues. OXINIUM, oxidized zirconium is a metallic alloy with a ceramic surface that provides wear resistance without brittleness. OXINIUM material combines the best of both metal and ceramics.
The combination of OXINIUM heads on XLPE liners offers:
• No risk of fracture, chipping or squeaking
• Hypoallergenic Biocompatible solution for metal sensitive patients
• Proven low wear rates
In addition, OXINIUM heads and XLPE liners are available in a wide variety of head sizes and neck offsets, which allow you the intraoperative flexibility to help restore a full range of motion.

09/03/2012
I am making notes of what I need to discuss with my surgeon pre-surgery on Monday:
1) Will he be willing to film the extraction of the DePuy ASR and also comment on any visible damage as a result of the DePuy ASR.
2) Will he be willing to photograph any damage caused by the DePuy ASR
3) I must have my periprosthetic tissues sent for testing, to see if they will reveal amounts of lymphocytic infiltrates, that can be suggestive of an immunologic reaction.

4) I want to retain possession of the prosthesis so that it can be sent in for testing.

5) I would like copies of his surgery/theater notes as soon as possible so that I understand what was found.

Procedures: My Hip Resurfacing Surgery

My resurfacing surgery was done on the 5th July 2010 by one of SA's most brilliant orthopedic surgeons. 

Risks: CANCER

Hip replacement patients could face increased risk of cancer (very important article) By Laura Donnelly, Health Correspondent , Tuesday, Feb 7, 2012 THE TELEGRAPH: ENGLAND

Fresh fears have been raised over the safety of hip replacements received by tens of thousands of British people. Early findings from a study on the effects of "metal-on-metal" devices suggest the implants could increase the risk of cancer and genetic damage.

One patient who took part in the research, and was found to have abnormal cell changes to the bladder, said he was now desperate to have his implant removed because he feared for his long-term health.
The British study is understood to have detected changes to cells in the bladders of more than one in five patients who were monitored after being given "metal-on-metal" hip replacements.

The disclosure of the study comes after last week's investigation by The Sunday Telegraph, which revealed that regulators have such grave concerns about the safety of 30,000 of the devices that they are preparing to issue new guidance on them.

Problems occur with the implants when friction between the metal ball and cup causes minuscule metal filings to break off, which can seep into the blood and cause inflammation, destroying muscle and bone.
There are also concerns that metal traces in the blood could put major organs at risk of being slowly poisoned, and increase the chance of cancer - in particular in the kidneys and bladder.

The new in-depth research on 72 patients found genetic damage to the bladders of 17 people - including three patients who developed full-blown cancer.

The proportion of patients who had suffered DNA damage may be significant, because such changes can cause mutations which in turn lead to cancer. Orthopaedic consultants in Bristol who undertook the study said they hope to present the results to other surgeons next month. Their study was launched after the Medicines and Healthcare products Regulatory Agency (MHRA) warned that all 40,000 Britons with "metal-on-metal" devices should undergo annual checks, with scans and blood tests if doctors find symptoms that suggest metal leakage.

A type of device made by one company, DePuy - a subsidiary of global health giant Johnson & Johnson - which was received by almost 10,000 patients was taken off the market in 2010 because of concerns about its high failure rate.  One of the participants in the trial, David Jose, 51, from Clifton, near Bristol, had a hip "resurfacing" operation in 2007, a year before retiring as a police officer. The father of two had been suffering hip pain from playing football and rugby. In May last year he was told that the tests had found atypical cells which were not at this stage cancerous.

He saw Angus Maclean, an orthopaedic surgeon at Southmead Hospital involved in the study, who said that the trial had established three cases in which patients had developed bladder cancer, and 14 more including Mr Jose who had changes to their chromosomes.

The doctor told him researchers "could not believe" what had been found, describing the findings as "shocking". He said he was expecting the research to "make front page news", when it was published in a couple of months' time. Nine months on, the findings have not been published. Mr Jose, who now suffers from a host of unexplained health problems has now undergone further procedures which have established that so far he does not have bladder cancer. However, he remains in fear about the consequences of the cell changes, and is desperate to have the device removed.

He said: "I do not know what this thing is doing to me; that is what is frightening, the fact that this is all unknown."

Mr Maclean said he could not talk about the study, except to say that he hoped the findings would be presented next month, at the annual British Hip Society conference. A spokesman for the University of Bristol, which is running the study, said analysis of the results from the trial was still ongoing, and that the research would be peer reviewed and published. The MHRA said there was no evidence of an increased incidence of cancer among people with metal-on-metal replacement hips.

A spokesman for DePuy said that since the recall decision, the company had worked to provide patients and surgeons with the information and support they needed.

Metal-on-metal implants were introduced in the UK in the 1990s when they were promoted as offering better mobility than replacements which use a metal ball and plastic socket.
They were seen as a better option for younger patients, who were likely to be more active and put more pressure on the joint.
The problems have been found to affect people of all ages but studies have found young and petite women are particularly at risk.

Many thanks to Connie from My DePuy Recall for this article on her blog.


Surgeons urge ban on new metal-on-metal hip joints

The British Hip Society, which represents surgeons carrying out replacements, is so concerned about the failure rate of the metal joints that it has said no more should be used.
There are currently 49,000 people in Britain with the large metal-on-metal hip joints.
The new statement from the British Hip Society comes days after the health devices regulator said all patients with the large diameter joints should have annual blood tests and possibly MRI scans for the lifespan of the joint.
The tighter regulations have been brought in after research showed the large joints rub together causing miniscule particles of metal to leach out into the surrounding tissue and bloodstream.
Experts in Bristol have found abnormal cells in the blood of patients with the hips that could trigger cancers, it has emerged.

Timeline: Metal On Metal Hips

1975: Study describeslocal tissue reactions caused by cobalt and chromium ions from metal-on-metal hips
1988: Study shows human synoviocytes killed by cobalt in vitro (Rae T.Clin Orthop 1988;232:244–54)
1989: Metal-on-metal hip resurfacing designs start in Birmingham
1990: WHO International Agency for the Research on Cancer lists trivalent chromium as a potential carcinogen and cobalt ions as a probable carcinogen
1991: First metal-on-metal hip resurfacing device is implanted in Birmingham
1994: Study shows dissemination of cobalt and chromium ions into lymph, liver, and spleen5
1996: Patients with metal-on-metal hips found to be at increased risk of cancer compared with those with metal-on-plastic hips: relative risk of haematopoietic cancer 1.59 (95% confidence interval 0.8 to 2.8) and leukaemia 3.77 (0.9 to 17.6) (Visuri T, et al. Clin Orthop 1996;329 (suppl):S280–9)
1997: Birmingham Hip Resurfacing (BHR) implant comes onto the European market
1998: Particles of cobalt and chromium shown to be toxic to monocytes in culture (Haynes DR, et al. Clin Orthop 1998;352:223-30)
2000: NICE guidance on selection of prostheses for primary hip replacement and resurfacing sets a benchmark revision rate for conventional hip replacement of ≤10% at 10 years
2003: Derek McMinn and Ronan Treacy publish paper showing positive results with BHR. This kickstarts the trend for larger heads in total hip replacement
2004 McMinn, designer of the BHR, says, “Caution still needs to be exercised until longer term results are available”
2004 One of DePuy’s modified stems with a shortened trunnion is cleared by the FDA, which says the modified design “does not raise any new issues of safety or effectiveness”
2005: Internal DePuy memo reflects early concerns about health risks of wear debris from metal on metal hips. “In addition to inducing potential changes in immune function, there has been concern for some time that wear debris may be carcinogenic”
2006: MHRA Committee on Safety of Devices says there’s growing concern over the biological risks of metal wear debris
2006: The Department of Health’s Committee on Mutagenicity concludes that “some metal on metal (those using cobalt-chromium) hip replacements may be associated with increased DNA-changes, and increased genotoxicity in patients.” It says this “may present a potential risk of carcinogenicity in humans”
2007: Implantation of large diameter metal-on-metal hips starts to increase rapidly in the UK, and resurfacing peaks. Metal-on-metal hips account for 20% of market this year
2007: UK expert advisory group chooses not to contraindicate metal-on-metal hips in women of child bearing age—even though metal ions had been detected in the umbilical cord and placental blood
2007: The MHRA’s Committee on Safety of Devices recommends that all patients sign a consent form setting out the risks associated with metal wear debris. But this recommendation is not widely communicated
2008: Study shows 20% of patients with DePuy’s Pinnacle hip system have metal ion levels over the upper limit accepted by occupational health experts
2009: Japanese surgeons raise concerns with the design of DePuy’s large diameter metal-on-metal system. They report seeing “generated metal debris between stem taper and head, and final necrosed tissue” and blame it on the poor connection between the two
2009: All joint replacement implants are re-classified as class III devices after the implementation of Directive 2005/50/EC
2010: In an internal email obtained by the BMJ, a senior figure in DePuy writes: “I feel the problem [with large diameter metal on metal] is emerging as more serious than first thought.”
2010: DePuy recalls its ASR hip prostheses. Some studies show a failure of the total hip replacement secondary to adverse reactions to metal debris of 50% at 6 years
2010: DePuy promotes Pinnacle—including metal-on-metal—as “an alternative for the majority of patients”
2011: Tony Nargol and his team warn the MHRA of failures with the Pinnacle implants
2011: British Orthopaedic Association writes to surgeons to say that large diameter metal-on-metal total hip replacements should be “carefully considered and possibly avoided”
2011: A two year follow-up study in 144 patients shows an incremental increase in metal levels over the study period in a range of large head metal-on-metal implants made by companies including Zimmer, DePuy, and Smith and Nephew
2011: FDA writes to about 20 manufacturers to say that it is requiring post-marketing studies in cases where an implant’s failure could have serious consequences. Companies would be expected to take blood samples from patients to measure metal ions.
2011: National Joint Register describes large diameter metal-on-metal and resurfacing prostheses in some people as a “cause for concern”
2011 Trial comparing large diameter Birmingham hip replacement with conventional hip is terminated after 2 years. Metal ion levels were raised above the MHRA advised safety level (7 µg/L) in 20% of the metal-on-metal group and in one patient in metal-on-polyethylene group (who had a metal-on-metal implant on the contralateral side)27
2012: At the annual American Academy of Orthopedic Surgeons conference manufacturers promote metal-on-metal products to the 40 000 attendees






With much thanks to Connie. Read her blog, My DePuy Hip Recall