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Implants - Regulation of Medical Devices, Medicines and Healthcare products Regulatory Agency (MHRA), News & Updates

UK Parliament: Statistics on Mesh Implant Surgery and Mesh Removals

In February 2012, Teresa Hughes of Meshies United Support Group asked her MP to table questions in Parliament regarding the number of surgeries undertaken to implant a TVT or TOT mesh to treat stress urinary incontinence and the number of surgeries undertaken to remove the TVT or TOT mesh.

Mr Shaun Woodward, MP for St Helen’s, asked the Secretary of State for Health the following questions:

  • how many NHS operations to treat stress urinary incontinence by insertion of a Trans Obturata tape (TOT) or Tension Free Vaginal tape (TVT) mesh sling in women had been performed in each of the previous eight years;
  • how many operations to remove such slings had been undertaken in the same period; and
  • how many adverse event reports associated with such slings had been recorded by the MHRA.

The results are shown in the tables below. (Results show statistics for England.)

Procedure

2006-07

2007-08

2008-09

2009-10

2010-11

Insertion of Transobturator Tape (TOT)

2,580

5,045

5,750

5,569

5,426

Removal of Transobturator Tape (TOT)

68

79

96

128

95

Insertion of Tension-Free Vaginal Tape(TVT)

6,137

8,817

8,503

8,397

8,087

Removal of Tension-Free Vaginal Tape (TVT)

287

417

506

475

508

Source: Hospital Episode Statistics (HES), Health and Social Care Information Centre.  Activity in English National Health Service hospitals and English NHS commissioned activity in the independent sector.  HES was unable to provide data for the years previous to 2006-07.

The Medicines and Healthcare products Regulatory Agency (MHRA) received 107 incident reports since 2005 involving vaginal mesh tapes used for stress urinary incontinence (SUI) as follows:

Adverse Incident Reports
2005 8
2006 25
2007 3
2008 18
2009 19
2010 15
2011 19

In addition the MHRA has also had six reports in 2010, and 19 in 2011, where the device was unknown but likely to relate to vaginal tapes for SUI.

Read Hansard record: http://www.publications.parliament.uk/pa/cm201212/cmhansrd/cm120220/text/120220w0008.htm#12022152000632

The above figures show a significant discrepancy between the number of surgeries recorded by the Hospital Episode Statistics (HES) and the number of “adverse events” recorded by the MHRA to remove TVT or TOT mesh.  To be exact, HES records for removals of TVT and TOT between 2006-2011 total 2,659 which contrasts markedly to the adverse incidents recorded by the MHRA for that same period: 124.

It raises questions about how well the MHRA system of adverse incident reporting is working, and whether the current system of voluntary reporting for medical devices is providing any useful information to the regulators about problems with mesh surgery.   In Earl Howe’s recent review of the action of the MHRA and department of Health over PiP breast implants, it was acknowledged that “reporting will never reflect 100% of the experience with a device and this means other information must be generated and used”.

It was also emphasised in this review that the MHRA “must be able to obtain evidence from a wider and more detailed set of sources, including robust outcomes data from clinicians”.  The report recommended that the MHRA be “at the forefront of using more sophisticated and rich sources of data to determine if there are problems with a device.”

Clearly, relevant and useful information (in the form of the statistics shown above) is available and at the disposal of the MHRA; at present, they do not appear to be making use of it.

What do you think?

How do you find the current system for reporting adverse events?  Have you tried to report your complications with the MHRA?  How did you find it? Did your surgeon report your adverse events with the MHRA? 

Could the regulators find a better way of monitoring problems with these implants? Do you think a national registry would be a better way of monitoring problems with these devices?

Or perhaps you think the MHRA could make better use of publicly available information, such as the figures above, sourced from the Hospital Episode Statistics? 

Are the MHRA doing enough to protect patients from potentially harmful medical devices?

Have your say – please leave a comment and tell us what you think …

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Discussion

7 thoughts on “UK Parliament: Statistics on Mesh Implant Surgery and Mesh Removals

  1. Thank you Teresa for obtaining these figures and TVT info for setting them out so clearly. Surely if a member of the public can obtain this information then the MHRA should also have it and not be relying on patients to report adverse events. Clearly change is long over due regarding regulation and reporting and the MHRA need to urgently review their procedures.

    Posted by S | May 24, 2012, 5:41 pm
  2. Yes, very grateful to Teresa for obtaining these figures through her MP. I agree that if this information is available, then why aren’t the MHRA making use of it? The MHRA stated they did not act on ‘anecdotal evidence’ with the PiP implants. Well, the above figures are not anecdotal, so why not draw evidence from them? It’s not rocket science.

    Posted by tvtinfo | May 24, 2012, 6:14 pm
  3. I tried for years to get information about the problems and stats related to these mesh tapes complications.

    Unfortunately it then took another few years to start a petition to give to Downing Street.and then talks at parliament.

    In the process of all this time of banging your head against a brick wall and the red tape getting put up in the way more and more women where suffering.

    It has taken a lot of challenging to these bureacrats to even get an answer back from them which always referred you on to someone else.

    It is called a wearing down process but thankfully as ill as we are and have all been, we have all had the determination, courage and strength to carry on this plight for answers.

    Posted by Teresa Hughes | June 8, 2012, 11:04 pm
  4. It is disappointing that it has taken so long to get answers and information from the people in charge and that you had to go through your MP (and many thanks to him) to get some facts about this surgery and the numbers of removals. However, your persistence has paid off, and the figures reveal that the numbers of complications are under-reported in the MHRA device reporting system. Let’s hope we get some action on this problem very soon.

    Posted by tvtinfo | June 9, 2012, 4:59 pm
  5. At long last an invitation has been offered by The Medicine Health Regulator Uk for me to meet and have talks with them.

    This has been a very long time in the making.

    I do hope that by having a meeting with The Medicine Health Regulator UK it will be quite fruitful and that they do listen and take some action to highlight how we are suffering and what serious complications can arise from this operation.

    We do need a health publicatin putting out in The United Kingdom.

    The true figures from parliament for England alone reveal a substanlial rise in transvaginal mesh removals which are not registered with The Mhra as adverse incidents/complications,

    Posted by Teresa Hughes | June 22, 2012, 10:52 pm
  6. I hope the meeting will be fruitful, Teresa, and that the MHRA will listen to your concerns and those of your support group. I’m afraid that mesh is still very popular with the medical community and many seem somewhat oblivious to the long term risks and experience of a growing number of women. Many surgeons are not reporting complications. We need action and we need it fast.

    Posted by tvtinfo | June 23, 2012, 12:23 pm
  7. How tragic, with all that Teresa Hughes worked for and exactly 4 years today June 22nd 2012 she posted that a meeting with the MHRA UK would be held, and Teresa Hughes acted in good faith as advocate for other injured women whilst seriously poorly herself…..Four years on and NO ACTION TO HELP OCCURRED & still the injuries continue,with new patients every day writing in to #mesh web sites for help & advice because our doctors DO NOT CARE . Patients’ lives in ruins and bodies in tatters. The MHRA UK didn’t listen, consistently quoting their fav excuse “the benefits out way the risks”….the whole point is that NO ONE WAS TOLD THE RISKS….and how could they tell us the risks….YOU DIDN’T DO ANY HUMAN TRIALS & therefore you allowed a catastrophically dangerous ‘ticking time bomb’ to be inserted into Human flesh, not giving a damn about the consequences for the injures that would befall innocent people .Only money is the issue here, THAT IS THE BENEFIT YOU ARE REFERRING TO,….and so MHRA UK now it is time you were questioned in PUBLIC and held accountable for serious crimes against the public under ARTICLE 3 HUMAN RIGHTS /Torture, AND ARTICLE 2 RIGHT TO LIFE.

    Posted by #TVTdisaster (@SusanMorgan19) | June 22, 2016, 7:47 pm

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