Our thoughts and concerns
Unfortunately some people do not understand how significant the Medicines and Healthcare Products Regulatory Agency (MHRA) Public Health Notice is for the UK. Although it has few words if read correctly it does show in the plural sense of the wording there are multiple manufacturers and multiple mesh products and they have also mentioned they have launched an investigation. Please scroll down this webpage to view the MHRA notice, peer articles and comments.
The main purpose of adverse reporting is to show the MHRA how many people are harmed and to collate data on all the TVTs/Meshes medical devices also to show the MHRA there is a real serious growing health problem in the UK. It is the MHRA who should be asking the manufacturers WHY is this happening and to give answers on their faulty medical devices, specifications, RCTs etc etc directly to them only and not to allow the manufacturers to approach ill people who are in a vulnerable state of health plus for putting the surgeons in a very awkward sitution after receiving permission to disclose private and confidential medical information between patient and surgeon, this is breaking patient confidentiality and also putting vulnerable people under pressure. Please click here to read more www.tvt-messed-up-mesh.org.uk/notice-mhra-concerns.html >>>
How Events are unfolding with the MHRA
We have been telling the MHRA for years via email, post and telephone there is a serious growing health problem. Then back in March 2011 they started to listen and had a meeting. We did request the minutes of the meeting but was declined, they could only supply their Agenda:
Date: Wednesday, 16 March 2011
WORKSHOP ON VAGINAL TAPES
151 Buckingham Palace Road, London, SW1W 9SZ
Please click here to read VT-Workshop-Agenda.pdf >>>
Date: August 4, 2011 Published online ahead of print on August 16,2011
Synthetic Vaginal Tapes for Stress Incontinence: Proposals for Improved Regulation of New Devices in Europe
Paul Abrams , Christopher R. Chapple, Marcus Drake, Suzy El-Neil, Susanne Ludgate, Anthony R.B. Smith.
Full PDF: august-2011-synthetic-vaginal-tapes-for-stress-incontinence>>>
Direct link to European Association of Urology:
Date: 2nd September 2011: MHRA Public Health Alert
Date: September 2011
Recent Public Health Alert issued from the MHRA
Advice from the MHRA:
Synthetic vaginal tapes for stress incontinence
The MHRA has seen a recent increase in numbers of adverse event reports in comparison to numbers received in previous years, increasingly from patients. As a result, the MHRA has launched an investigation to better understand the use of these devices and the complications associated with their use. Please click on the following links to read more:
Please read some comments as below:
By: Our Medical Expert
ARTICLE - EUROPEAN UROLOGY JOURNAL - SYNTHETIC VAGINAL TAPES - PROPOSALS FOR IMPROVED REGULATION
It is a very good article and demonstrates that the profession is beginning to recognise the problem. It does call for a National Register. This is a major step forward. The BAUS and the BSUG would not produce such an article unless they had serious concerns.
There are, however, many more questions and points that need to be considered:
1. The paper describes the MHRA meeting. Will the MHRA now put the article or a warning notice on their website? This has now been done please see links above.
2. I have been in contact with the MHRA and they are keen to set up a National Register. Although the BAUS and BSUG should promote such a Register, it is essential that there is input from those who do not have a vested interested in promoting this sugery.
3. The article states that the MHRA know that there has been considerable under-reporting. They state 42 reports in 2010. If you look at the suggested problems to be reported, then I would say that there are probably at least 42 such problems per year in each large hospital!
4. There is no suggestion that a Register should be retrospective. However, these devices have been in use for 15 years and there is a need to address those already affected. This could be achieved by launching a national recall letter to patients similar to the recent practice with metal hip joints.
5. The article does not deal with the use of mesh for vaginal proplapse. This is important as the FDA has effectively banned its use except in clinical trials. This use of mesh has become quite widespread in the UK. Should the MHRA issue a warning , similar to the FDA, about this use?
6. The article does not really deal with one of the major problems i.e. lack or sufficient information to obtain valid consent prior to the operation and lack of detailed explanation about the potential serious side-effects and the discussion of alternative management options. This is very important because it is one of the main complaints heard from patients who ask why they were not properly informed about the risks.
7. The article does deal with training and competence but does not make sufficient recommendations about the need for multi-disciplinary urology -urogynaecology teams to deal with difficult cases and to manage those affected by serious complications. There are still too many surgeons working on their own especially in the private sector.
8. The article does not deal with the exaggerated success claims made by some surgeons on their private practice websites. These websites often quote unproven personal subjective figures which are way above the published objective results in published journals. The article also does not deal with the unfortunate tendency for some surgeons to ' pass the buck ' when faced with complications of their surgery.
9. Finally, the European Urology Journal is not widely read among urologists in the UK and I doubt if many UK urogynaecologits ever look at it. A statement from the MHRA, BAUS and BSUG via the Royal Colleges and NICE or NPSA would be more widely seen. It should be mentioned in the BMJ News Section. Certainly, every UK NHS Trust Clinical Governance Lead, Medical Director and Womens Health and Urology Clinical Directors should see this article.
Latest news from the MHRA Year April 2012 to Present
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Archive work done with the MHRA from Year 2010 to March 2012
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Public Health Alert issued from the MHRA
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Out thoughts on the MHRA
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There are many people who have signed our online petition and some have shared their stories, also some people have downloaded a copy to collect signatures. It is fantastic to see the men are starting to sign the petition too, we need you all to support our cause and help all women who are wives, mothers, grandmothers, sisters and daughters suffering.
To return back to the MHRA News please click on the link below:
You will see and hear from people who decided not to go ahead with surgery after reading our website. They have been saved from harm!
For more information on our petition please visit here www.tvt-messed-up-mesh.org.uk/petitions.html >>>