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Medicines and Healthcare products Regulatory Agency (MHRA), Reporting your Complications

Reporting your Complications to the MHRA

At the moment there is no national registry for pelvic mesh implants and so nobody really knows the extent of the problem, ie. they don’t really know the numbers of people suffering complications from this surgery.  There have been calls for a national registry but this seems a long way off at present.  The only system in place at the moment in the UK for reporting problems with mesh medical devices is a voluntary reporting system run by the Medicines and Healthcare products Regulatory Agency (MHRA). Doctors and manufacturers are supposed to report adverse incidents to the MHRA. You can also report your complications to the MHRA either by downloading the form and putting in the post or by using the on-line reporting system.

Complications can be classed as ‘adverse incidents’.  An adverse incident is an event that causes, or has the potential to cause, “unexpected or unwanted effects involving the safety of device users (including patients) or other persons”. You can report your complications or “adverse incidents” to the MHRA using the on-line form for patients:

http://www.mhra.gov.uk/Safetyinformation/Reportingsafetyproblems/Devices/index.htm

You will be asked for the device name, model and serial number and these important details should have been recorded at the time of your surgery and will be in your hospital records.  If you do not have these, you can still submit your report if you know what type of mesh device you had (eg TVT, TOT etc) but they will not investigate your case – however, they will add the details to a database so it is still important to send your report.

You can ask your surgeon for the mesh device model and serial number – this information should be attached to the operating notes on a sticker.    If the doctor is not forthcoming with this information, you may have to go through the Medical records office of your hospital and write to the Records Manager to ask for your medical records.  This will take time as they may send you a form out first following your request and ask you which records you want.  You can save money by only requesting certain records if you wish.  You do not have to give a reason for wanting copies of the records. When they receive your form, they will write to you telling you how much you need to pay and requesting payment before they release the records.  You can request your full records if you wish.  See the following on how to access your medical records:

http://www.nhs.uk/chq/pages/1309.aspx?categoryid=68&subcategoryid=160

Reporting your adverse event will help to highlight the problems associated with these meshes.

READERS!

Have you tried to report your adverse events to the MHRA?  What was your experience of the process?  Please comment below.

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  1. Pingback: NHS National Patient Safety Agency « tvtinfo - April 1, 2012

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