Tags
DePuy, Great Western Hospital, Hip Replacement, Magnetic resonance imaging, Medical device, Medicines and Healthcare products Regulatory Agency, metal, Nephew Smith, Smith
Correspondence from an “in pain and damaged BHR recipient”
To:
[deleted doctors name]
Biosciences & Implants Unit
Medical Devices Division
Medicines and Healthcare products Regulatory Agency (MHRA)
4th Floor, Area A
151 Buckingham Palace Road
London SW1W 9SZ
Good Afternoon,
I am contacting you as I am currently at my wits end with regards the
Birmingham Hip Resurfacing and the extreme complications I am facing.
I had surgery at Great Western Hospital in 2006. I was told this was revolutionary new surgery that would change my life. It has certainly done that. I am facing having this implant out and a revision to a conventional hip replacement, bone grafts in my pelvis as the implant has worn it paper thin, pseudo-tumours around the implant need to be removed, one of which is on my main artery, potential soft tissue damage (waiting on MRI results on extent of this) and then the metal poisoning from the ions, my Cobalt sitting at 383 and Chromium at 410.
There are then the side effects of this, deafness which no-one will confirm nor deny is associated with it, extreme tiredness, memory loss, then the obvious mobility problems.
I am 43 years old with the body of an old woman. I am on a range of medication, including morphine. I have no quality of life, my job is at risk due to long term sickness, ironic as I work in the Welfare to Work sector!
If you are familiar with the DePuy case, which I am sure you are, you will see the similarities, however, mine is a Smith and Nephew. I have spoken the various solicitors and all have said the same, I need group litigation and not enough people have come forward yet. I find this disgusting, I am suffering, my consultant stated they now know I wasn’t a suitable candidate yet no-one wants to recompense me for the impact on my life! My own GP knows only what I tell him from my own research, how can I be fully supported?
Surgery was agreed in September 2011, I now have a date for 24 Feb 2012, a long
wait when you are suffering as I am. I have been told. The surgery is too complex and the risks too high to be carried out at Great Western Hospital in Swindon, my local hospital where original surgery was carried out, my care has been transferred to Nuffield in Oxford, a long trek for my children to visit me.
I am hoping you can advise me on where I go for assistance, who do I contact for recompense and most importantly what are the Ministers for Health doing to investigate these cases, I can assure you I am not an isolated Smith and Nephew case! Why is it deemed acceptable to use people as human guinea pigs, say sorry we got it wrong and then ignore the pain and suffering?
The breast implants from France in the news at the moment, the government want
them withdrawn immediately, this has only just come to light, people such as myself have been suffering for years and no-one cares. I am feeling really quite despondent at the moment, especially as no-one can even reassure me that replacing my implant will relieve the pain and suffering, the failure rate after a problematic BHR is high.
Where does that leave me?
I look forward to hearing from you in due course.
Kind Regards
[deleted]
Marlborough
Wiltshire
SN8 1EP
The Doctor’s Reply
From: [Deleted]
Date: Fri, 13 Jan 2012 08:40:06 -0000
To: [Deleted]
Subject: DE669859 – Smith and Nephew Birmingham Hip Replacement
Dear Ms [deleted],
Thank you for your recent email to the Department of Health.
Your email has been passed to me for attention and I have raised an adverse incident report on this case, so that the information that you provided will remain on our database and will be reviewed regularly. You may be aware that MHRA is responsible for medical device performance and safety issues, rather than any clinical or financial issues.
I am very sorry to hear about the problems that you have experienced with your Birmingham Hip Resurfacing and I understand your frustration. The description you have given in your email suggests that you may have experienced a soft tissue reaction with the metal on metal hip implant. MHRA has recently published a report, of the Expert Advisory Group (EAG) on looking at soft tissue reactions associated with metal-on-metal hip replacements. (http://www.mhra.gov.uk/home/groups/dts-bi/documents/websiteresources/con097079.pdf).
The report notes that problems with Metal-on-Metal implants, similar to the ones that you have unfortunately experienced, are rare and their root cause remains largely unknown. These soft tissue reactions can occur with any metal on metal implants. However, so far the available evidence suggests that following removal of the implants, the metal ion levels in the body are returning to normal.
We also published a Medical Device Alert (http://www.mhra.gov.uk/home/groups/dts-bs/documents/medicaldevicealert/con079162.pdf) in April 2010 in line with the recommendations given in the EAG report. The advice in the Alert recommends that all patients implanted with metal on metal implants should be followed up.
MHRA is working closely with the National Joint Registry (http://www.njrcentre.org.uk/njrcentre/default.aspx) on identifying problems with orthopaedic devices and so far we are not aware of issues with this device.
When a device fails, their manufacturer is obliged to carry out an analysis of the explanted device and identify the root cause of the failure. MHRA has an oversight of the manufacturer’s analysis and conclusions. I understand that your implant is due to be explanted on 24 February 2012. Therefore if you would like us to take this case forward we would be very grateful for the following further specific information from you please:
a) (If known) The catalogue number and serial number of your implant.
b) The contact details of your explanted surgeon and confirmation that you are content for us to contact him/her.
c) A confirmation that you are content for us to contact the manufacturer, Smith and Nephew, let them know of this case and request them to collect the explanted device in due course and analyse it.
As part of our role we would report back to you on the potential cause from the manufacturer’s conclusions and our assessment of this. I hope that the above is helpful, however, please let me know if you have any questions.
I would like to take this opportunity to wish you all the very best with your forthcoming revision operation.
With kind regards,
[Doctors name deleted]
Senior Medical Device Specialist
Biosciences & Implants Unit
Medical Devices Division
Medicines and Healthcare products Regulatory Agency (MHRA)
4th Floor, Area A
151 Buckingham Palace Road
London SW1W 9SZ
Relevant Paper to read – click to download – MoM final report 26-10-2010
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I am so sorry to hear of this case and the suffering of this lady whose life has been forever changed by these circumstances. Especially since Mr Universe is touting it as the best thing since peanut butter and jelly sandwiches! I find it rather interesting that in order to have the explanted hip reviewed and examined is going to be done by the very manufacturer of the product. This medical device should not be sent back to the manufacturer, but should be sent to an independent lab for analysis! What kind of collusion must be going on if the very department that is in place to protect the comsumers from such tragedies is not equipt to, at the very least sub-contract an independent lab for such analyitical information.
You aren’t alone, although it may seem that way especially when you are looking for help, for answers, I and others are available. I an trying to utilize the fact the BHR was denied then approved in the USA by using a test group from abroad and not even from USA. If we can approve a device with no test in USA then there must be a way for your legal system and our legal system to utilize these terrible events in a combined legal effort to represent us. You will have to be stronger then you ever have before living through this continuous nightmare. It isn’t easy, not one day. My name is Howard Sadwin(hbs924@verizon.net) You can read about my disaster. I still am suffering beyond explanation. From the time the BHR was put into me until present. It was removed in 2010, I get out of bed, into my wheelchair, clean up, by using a special chair in my shower and special chair on my toilet. After dressing, and breakfast my day is comprised of going to my doctors office for blood work every week, sometimes I see him more often, I see my surgeon in his office, as they watch over me like hawks, for fear of any new health issues that may occur from this debacle. I go to therapy, come home, knap, then work on this matter for as long as I can. Just dealing with this drains my strength enormously. You can understand, as others whom are suffering unnecessarily. Although the BHR has worked for others, it has taken my quality of life away from me and my family,friends,animals,financially, emotional,physically etc. Yet I go to the gym in my wheelchair 3 times a week trying to gain enough strength to endure the task that lies ahead for me.
First and foremost you must direct your energy and inner strenghs as best you can, I know its not easy, but inorder to establish your health and get better try to take all the anger you must feel inside and all the negativeness and try,try,try, to reverse the hostilaty into positiveness. Once you have a grip on my suggestion then pursue a passage that will get the actions you seek through. Because our laws are so different, my only suggestion, is try to gather as many people who also are having problems with their BHR. A show of numbers is a show of strength, this can’t be pushed aside as it has in USA as well as your country, numbers represent a show of strength. No governing body can ignore numbers. The bhr was used a lot less in USA then others, De PUY, Johnson+Johnson,Biomet etc. yet there are many who are beginning to come forward, more and more will eventually come forward. We as human beings have the right for accountibility from the device manufacturers, and if their device caused you,me or anyone else harm they should be held liable.
This has never been truely tested in our court system whereby a jury has handed a verdict, settlement out of court or dismissal is the only thing of sugnificant record appears in our records.
The only solice I have for you is my words above and my willingness to help in any way I can.
I will due whatever I can to see the laws are changed, so the quality of human life is far more important then Market Share and Finances. I will help anyone I can, I am not an attorney nor am I a physician, but I am a human being and I will see justice is properly served.
A friend of mine sent me a great story and in the story is a paragraph I read daily
God promises a safe landing, not a calm passage. If God brings you to it, He will bring you through it.
Respectfully
Howard Sadwin
Thank-you, I am doing as much research as possible, like you Howard it fills my waking moments! I will endeavour to keep you all updated with any new developments. If possible I would rather the joint didn’t go back to the manufacturers for obvious reasons. I have heard that they destroy them in their testing thus removing any evidence! I have been advised that anything they remove, including growths, tissue etc be preserved for legal action.
Thank-you for your support
Tracy, I have my own story somewhere in this blog but check out on google London Implant Retrival Centre. It is run by surgeons of Imperial College London who are carrying out research for all including MHRA. I have posted some links to one of their reports plus one from McMinn (co-inventor ofBHR). My story and these links are under ‘another Smith & Nephew problem’ on this site. Good luck. Gayle
Hi Tracey
How is it going?
Earl
Dear Tracey,
Please help, my partner is also 43 and 2 years ago had a metal on metal hip replacement.at Great Western Hospital. He has been ill ever since, extreme tiredness, pain in in groin etc, we even went to Savenake Hospital last year for an x-ray because we thought because of the pain he was in that it had loosened, but we were told everything was fine. Today 2/2/2012 we turned up at orthapedics at Great western to ask if there was a problem with his replacement, we knew from their faces that there is, but we were given no information at all. This is why I have trawled the internet and found this blog. We live in East Kennett, Marlborough, could you please e-mail us or telephone 01672 861221 so as we can discuss with you what is going on, because nobody else seems to be prepared to tell us.
Kind regards
Toni and Marcus
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Gayle, I feel your suffering every day of my life. Your primary objective: get as well and as strong as you can. You will need to do this in order to keep moving forward in your life. You will need all the strength and determination you have ever had to use in order to pursue this matter. Don’t get discouraged, by what you are told, lawyers. There aren’t many attorneys in your country nor mind that are porperly equiped to take on this matter in the courts. Remember there haven’t been jury verdicts declaring human beings right and medical device manufacturers wrong. Smith + Nephew’s BHR wasn’t used any where as much as the other hip devices, however ” metal on metal ” hips pose a definite danger to one’s health. If you or anyone is having problems seek proper medical advice and remedy: then decide a course of action, if you have a legitimate problem caused by the device. This is the only way the laws in your country or mine can be changed in order to protect human life first, medical device second.
Howard Sadwin
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You may want to talk to my attorney Jeff Morris ( e-mail or 941 484 0646. He is communication with a law firm in UK re: BHR
Be free to use my name when you contact him, Howard Sadwin, there is no obligation, I’m sure he maybe of help.
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I personally had a Birmingham hip implant (Smith & Nephew) in February 2008 and started with extreme pain after a short time due
to the pseudo tumour from the metal on metal unit. I am male 64 and the reason for the initial operation was Perth’s disease from the age of 8 Years old. The NHS performed many tests including MRI,X-rays,CT scans, Ultasonic scans and even a ultrasonic guided injection over the next three years and finally the consultant agreed to give me a revision operation in October 2010. After a prolonged wait and increasing pain I rang the PCT NHS after 23 weeks and told them that under article 56 of the EU Convention I had the right to go to another country and that they would have to pay. I found a hospital and surgeon in Lille, France who specialised in metal on metal replacements and also is an expert in bone restructuring who was also doing tests on the prostheses recovered during his operations. I elected to go to his hospital and pay up front allowing the doctor to rid me of the pain.
He told me that the tumour was 150mm on the old prostheses and it was a very difficult operation. He also told me that the tumour was attached to many blood vessels and had the tumour burst while I was on the operating table the contents of the tumour would have gone around the whole body and if it was not benign I would have died within
48 hours and he would not have been able to save my life.
It is time that Smith & Nephews were responsible enough like the American Depuy company to accept that the metal on metal is wrong and should be prepared to accept the consequences.
If they can not, then the British Government should make them take responsibility.
I had the revision operation in April 2011 and am still in pain but it is decreasing very slowly or if not I am getting used to the level of pain
still.
Harold Tock
I do not know what a gravitar is?
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Toni
I have emailed you, I am more thaan happy to help youu guys, you are just up the road from me so we can support each other on this. I am not taking this lying down, there is much we aren’t being told and there is a lot of closing ranks.
Tracey xxx
For your information, I had my Attorney speak to Christian Beadell and I have been texting back and forth with Christian, he is with Goodmans Law. Their address is Wellington House, 4-6 St. John’s Road, Waterloo, Liverpool, L22 9QG. Telephone 0151 257 6000
e-mail
They were accepting BHR (hip) clients. you may want to try them. They more than likely are trying to create a group large enough to defer expense of discovery, and trying the case. As long as you are confident and comfortable with their firm and that they are representing your best interest.
Hope this maybe of help.
Howard Sadwin
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