View of the MHRA – Medicines and Healthcare Regulatory Agency


The MHRA claim the operation has a 1-3% failure rate but campaigners believe they cannot create such a figure as there is no National Register of failed devices. To report a failure you must pay for your hospital notes costing up to £50.

You then have to find the batch number and model name and go through the MHRA yellow card reporting system.

“Most of my case studies haven’t reported it as they hadn’t heard of the yellow card reporting system. Neither have ,” said Kath Sansom.

Surgeons are encouraged to report problems but many don’t as it is not mandatory to do so.

In 2012 The Department of Health, the NHS Commissioning Board, NHS surgeons and the MHRA said they were taking action to help reduce the side effects after surgery.

They also promised to set up a registry making it mandatory for surgeons to report problems with the TVT.

Three years later this is still not in place.

A spokesman for the MHRA said: “The MHRA continues to sympathise greatly with women who have suffered complications after surgery for lifestyle changing incontinence and organ prolapse.

“As part of a review on vaginal tapes and meshes the MHRA looked at a wide range of data and information available from a number of sources that enabled us to conclude the benefit risk.  This included not only adverse incident reports but information from manufacturers and Notified Bodies and published information from Heath and Social Care Information Centre (HSCIC), professional clinical associations, literature, patient support groups, other EU countries and worldwide.

“We will continue to monitor their safety and performance and we continue to encourage women to report any adverse incidents to us via the Yellow Card Scheme Any women who are concerned should speak to their doctor or surgeon.

“All surgical procedures carry a small element of risk and the MHRA continues to works in collaboration with patients, the NHS, professional bodies and international partners to ensure emerging issues are detected and acted upon quickly.”

Dr Susanne Ludgate, Clinical Director for Medical Devices at the MHRA, said in 2010 she was: “Appalled at how many devices are brought to market with a lack of appropriate clinical data.” in evidence submitted to the Justice Committee by the centre for evidence-based medicine and the British Medical Journals. (f)


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