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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 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 for patients to report problems with mesh 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 but compliance is low.

You can report your complications or “adverse incidents” to the MHRA using the on-line form for patients.  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”.

When completing the form, you will be asked for the device name, model and serial number – the implanting surgeon should have recorded these details at the time of your surgery.  This information will be on a sheet 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 your case may not be investigated – however, they will add these details to a database so still send your report.

If you don’t know the implant details, you can ask your surgeon.  The information should be attached to the operating notes on a sticker.    Or you can 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 will 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 may help to highlight the problems associated with these meshes. 

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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