How many adverse incidents reports for surgical mesh devices in Wales

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Dear Medicines and Healthcare products Regulatory Agency,

Please could you tell me the number of adverse incident (medical devices) reports you have received across Wales for each year 2011 - 2017. Please could you list each years figures separately and in the following catagories
Vaginal Mesh (for prolapse, SUI etc)
Hernia Mesh
Total number each year for all surgical mesh adverse incident reports.

Yours faithfully,

Karen Preater

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 17/410
       
Dear Mr Preater,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
       
Thank you for your enquiry which we received on 15 September 2017.
       
I confirm that your request is being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.
       
Kind Regards,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [email address]
Stay connected: mhra.gov.uk/stayconnected

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

MHRA Customer Services would like to recall the message, "FOI 17/410 - Freedom of Information request - How many adverse incidents reports for surgical mesh devices in Wales".

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 17/410
       
Dear Mr Preater,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
       
Thank you for your enquiry which we received on 15 September 2017.
       
I confirm that your request is being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.
       
Kind Regards,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [email address]
Stay connected: mhra.gov.uk/stayconnected

Queries, Devices, Medicines and Healthcare products Regulatory Agency

MHRA reference: FOI 17/410

 

Dear Karen Preater,

 

Thank you for your information request for ‘the number of adverse incident
(medical devices) reports you have received across Wales for each year
2011 – 2017’.

 

To comply with our confidentiality obligations we can’t split the data
into individual years because the numbers of reports are low and if put
together with other information, might make the individual reports
identifiable to specific patients or healthcare organisations.  Therefore
we have provided the information grouped for the date range 2011 to 2017,
presented in the table below.

 

It should be noted that these figures include a range of recognised
complications related to this type of surgical procedure and do not
necessarily indicate a fault with any particular device.   They include
reports from manufacturers, healthcare professionals and members of the
public.  It should also be noted that reported incidents may not
necessarily represent an individual patient and because there is no
limiting time on reporting, trends need to be interpreted using other
data.

 

 

Reports of adverse incidents received from Wales

Number of reported adverse incidents
Device Description 2011-2017
Implantable meshes:  
Vaginal mesh for incontinence 38
Vaginal mesh for prolapse 19
Vaginal mesh - unknown indication of
use Less than 5
Abdominal & hernia mesh 7

 

 

If you disagree with how we have interpreted the Freedom of Information
Act 2000 with regards to your request, you can ask for the decision to be
reviewed. The review will be carried out by a senior member of the Agency
who was not involved with the original decision.

 

Yours sincerely

Devices Division

Medicines and Healthcare products Regulatory Agency, 151 Buckingham Palace
Road, London SW1W 9SZ

 

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