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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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