Asked by: Graeme Morrice (Labour - Livingston)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what assessment his Department has made as to the accuracy of the databases of the British Society of Urogynaecology and British Association of Urological Surgeons as indicators of the total number of adverse effects in transvaginal mesh implants.
Answered by Norman Lamb
The Department, NHS England and the Medicines and Healthcare products Regulatory Agency (MHRA) have been working collaboratively to address the serious concerns that have been raised about transvaginal mesh implants. A working group has been set up to discuss these and will cover a range of issues including better collection and coordination of information on patients outcomes including complications, incident reporting and the need for a register. It will also consider how the British Society of Urogynaecology/ the British Association of Urological Surgeons databases can assist in providing information on the use of transvaginal mesh implants, patient outcomes and complications and the use of these databases by professionals. The working group will also look at ways of working with devolved administrations to improve incident reporting to the MHRA and the development of patient consent forms.
Asked by: Graeme Morrice (Labour - Livingston)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what consideration he has given to making the reporting of adverse effects in transvaginal mesh implants mandatory.
Answered by Norman Lamb
The Department, NHS England and the Medicines and Healthcare products Regulatory Agency (MHRA) have been working collaboratively to address the serious concerns that have been raised about transvaginal mesh implants. A working group has been set up to discuss these and will cover a range of issues including better collection and coordination of information on patients outcomes including complications, incident reporting and the need for a register. It will also consider how the British Society of Urogynaecology/ the British Association of Urological Surgeons databases can assist in providing information on the use of transvaginal mesh implants, patient outcomes and complications and the use of these databases by professionals. The working group will also look at ways of working with devolved administrations to improve incident reporting to the MHRA and the development of patient consent forms.
Asked by: Graeme Morrice (Labour - Livingston)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what representation he has received from (a) patients, (b) professional bodies, (c) the MHRA and (d) mesh manufacturers on a mandatory adverse effect register for transvaginal mesh implants.
Answered by Norman Lamb
The Department, NHS England and the Medicines and Healthcare products Regulatory Agency (MHRA) have been working collaboratively to address the serious concerns that have been raised about transvaginal mesh implants. A working group has been set up to discuss these and will cover a range of issues including better collection and coordination of information on patients outcomes including complications, incident reporting and the need for a register. It will also consider how the British Society of Urogynaecology/ the British Association of Urological Surgeons databases can assist in providing information on the use of transvaginal mesh implants, patient outcomes and complications and the use of these databases by professionals. The working group will also look at ways of working with devolved administrations to improve incident reporting to the MHRA and the development of patient consent forms.
Asked by: Graeme Morrice (Labour - Livingston)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what plans his Department has to (a) commission research on, (b) consult on and (c) introduce a standard patient consent form for transvaginal mesh implants.
Answered by Norman Lamb
The Department, NHS England and the Medicines and Healthcare products Regulatory Agency (MHRA) have been working collaboratively to address the serious concerns that have been raised about transvaginal mesh implants. A working group has been set up to discuss these and will cover a range of issues including better collection and coordination of information on patients outcomes including complications, incident reporting and the need for a register. It will also consider how the British Society of Urogynaecology/ the British Association of Urological Surgeons databases can assist in providing information on the use of transvaginal mesh implants, patient outcomes and complications and the use of these databases by professionals. The working group will also look at ways of working with devolved administrations to improve incident reporting to the MHRA and the development of patient consent forms.
Asked by: Graeme Morrice (Labour - Livingston)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what discussions his Department has had about transvaginal mesh implants with (a) the Scottish Government, (b) NHS Scotland, (c) NHS England and (d) NHS Wales in the last three years.
Answered by Norman Lamb
The Department, NHS England and the Medicines and Healthcare products Regulatory Agency (MHRA) have been working collaboratively to address the serious concerns that have been raised about transvaginal mesh implants. A working group has been set up to discuss these and will cover a range of issues including better collection and coordination of information on patients outcomes including complications, incident reporting and the need for a register. It will also consider how the British Society of Urogynaecology/ the British Association of Urological Surgeons databases can assist in providing information on the use of transvaginal mesh implants, patient outcomes and complications and the use of these databases by professionals. The working group will also look at ways of working with devolved administrations to improve incident reporting to the MHRA and the development of patient consent forms.
Asked by: Graeme Morrice (Labour - Livingston)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what steps his Department has taken to address patient concerns regarding the use of transvaginal mesh implants.
Answered by Norman Lamb
Work to improve outcomes for women undergoing procedures involving urethral tape and vaginal mesh is currently under way and is being led by NHS England. The Department is involved in this work alongside the Medicines and Healthcare products Regulatory Agency (MHRA), the specialist societies (The British Society of Urogynaecology (BSUG) and The British Association of Urological Surgeons (BAUS)) and the Royal College of Obstetricians and Gynaecologists.
In addition, Professor Sir Bruce Keogh, Medical Director, NHS England has written to the National Health Service to highlight the need to ensure that
- National Institute for Health and Care Excellence guidance for these procedures is followed;
- consent procedures are standardised so that they comply with up to date evidence and follow BSUG and BAUS guidance;
- all pelvic organ prolapse procedures and all incontinence operations, but particularly those involving mesh, are recorded on a recognised database e.g. the BSUG or BAUS surgical databases;
- all adverse events are reported to MHRA; and
- surgery for removal of tapes or prolapse mesh or repeat surgery for incontinence or prolapse is performed in units which can demonstrate relevant specialist care.
Asked by: Graeme Morrice (Labour - Livingston)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, how many (a) meetings, (b) items of written correspondence, (c) phone calls, (d) consultation responses, (e) tenders and (f) other individual communications and contacts his Department has had with (i) Johnson & Johnson, (ii) Ethicon and (iii) BARD.
Answered by Norman Lamb
Within the last 12 months, the Department has had regular communication with a number of pharmaceutical, device and diagnostic manufacturers, on a wide range of topics. However, the information requested could only be provided at disproportionate cost.
Asked by: Graeme Morrice (Labour - Livingston)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what representations his Department has received communicating concerns with polypropylene transvaginal mesh implants.
Answered by Norman Lamb
The Department of Health does not hold information on the number of patients who have required further operations due to complications with transvaginal mesh implants in each of the last three years or the costs of these operations.
The Department has had two meetings in which polypropylene transvaginal mesh implants were either discussed or on the agenda.
NHS England manages the National Reporting and Learning System (NRLS) for patient safety incident reports from the NHS. NHS England shares incident reports concerning harms arising from medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA).
Manufacturers of medical devices such as transvaginal mesh implants are legally required to report adverse incidents (ie death, serious injury or potential serious injury) involving their devices to the MHRA. General Medical Guidance published in February 2013 makes it clear that clinicians should report medical device incidents to the MHRA, and make information available to patients about how they can report side effects to the MHRA. The MHRA also encourages voluntary reporting of adverse incidents by healthcare workers, carers, patients and members of the public and participates in monthly telephone meetings with regulators in other European Union member states to share information about medical device safety.
The Department is currently engaged in work to assess the effectiveness of existing arrangements for reporting complications relating to transvaginal mesh implants. NHS England is leading this work, which also involves the MHRA, the Royal College of Obstetricians and Gynaecologists, and the relevant professional societies (the British Society of Urogynaecology and the British Association of Urological Surgeons).
Finished Consultant Episodes for women who have received a primary or secondary operative procedure for the insertion of Transvaginal Mesh, Transobturator Tape, Transvaginal Slings and Transvaginal Tape.
Procedure | 2010-11 | 2011-12 | 2012-13 |
Insertion of Transvaginal Mesh | 1,636 | 1,524 | 1,310 |
Insertion of Transobturator Tape | 5,426 | 4,885 | 4,476 |
Insertion of Transvaginal Sling | 130 | 134 | 135 |
Insertion of Transvaginal Tape | 8,087 | 8,172 | 7,627 |
Source: Hospital Episode Statistics (HES), Health and Social Care Information Centre.
Note: Activity in English NHS Hospitals and English NHS commissioned activity in the independent sector.
Adverse events reported to MHRA by Health Professionals concerning Vaginal tape and mesh implants are as follows
Vaginal Tapes for Stress Urinary Incontinence | Vaginal Mesh for Pelvic Organ Prolapse | Vaginal Mesh for unknown* indication | |
2011 | 3 | 1 | 0 |
2012 | 23 | 31 | 2 |
2013 | 27 | 20 | 0 |
Up to March 2014 | 16 | 7 | 0 |
*The reporter did not provide enough information on what type of mesh it was
Number of patient safety incidents relating to mesh used in gynaecological procedures reported to the NRLS (Year of occurrence by reported degree of harm)
| No Harm | Low | Moderate | TOTAL |
2011 | 0 | 2 | 4 | 6 |
2012 | 7 | 4 | 3 | 14 |
2013 | 4 | 1 | 1 | 6 |
TOTAL | 11 | 7 | 8 | 26 |
Search strategy: All incidents from gynaecological specialties in the NRLS were searched on 2 December 2013 for the keyword ‘mesh'
Adverse events reported to MHRA by patients/members of the public concerning Vaginal tape and mesh implants are as follows
Vaginal Tapes for Stress Urinary Incontinence | Vaginal Mesh for Pelvic Organ Prolapse | Vaginal Mesh for unknown* indication | |
2011 | 33 | 7 | 3 |
2012 | 26 | 2 | 0 |
2013 | 30 | 10 | 3 |
Up to March 2014 | 7 | 0 | 0 |
*The reporter did not provide enough information on what type of mesh it was
No incidents relating to transvaginal mesh have been reported to the NRLS by patients.
The Department has answered 11 previous Parliamentary Questions, 27 letters from hon. Members and Peers and 17 letters from members of the public since 1 September 2011. The Chief Executive of the MHRA has replied to six letters from hon. Members since 1 September 2011.
Asked by: Graeme Morrice (Labour - Livingston)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, how many patients have reported complications with polypropylene transvaginal mesh implants in each of the last three years.
Answered by Norman Lamb
The Department of Health does not hold information on the number of patients who have required further operations due to complications with transvaginal mesh implants in each of the last three years or the costs of these operations.
The Department has had two meetings in which polypropylene transvaginal mesh implants were either discussed or on the agenda.
NHS England manages the National Reporting and Learning System (NRLS) for patient safety incident reports from the NHS. NHS England shares incident reports concerning harms arising from medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA).
Manufacturers of medical devices such as transvaginal mesh implants are legally required to report adverse incidents (ie death, serious injury or potential serious injury) involving their devices to the MHRA. General Medical Guidance published in February 2013 makes it clear that clinicians should report medical device incidents to the MHRA, and make information available to patients about how they can report side effects to the MHRA. The MHRA also encourages voluntary reporting of adverse incidents by healthcare workers, carers, patients and members of the public and participates in monthly telephone meetings with regulators in other European Union member states to share information about medical device safety.
The Department is currently engaged in work to assess the effectiveness of existing arrangements for reporting complications relating to transvaginal mesh implants. NHS England is leading this work, which also involves the MHRA, the Royal College of Obstetricians and Gynaecologists, and the relevant professional societies (the British Society of Urogynaecology and the British Association of Urological Surgeons).
Finished Consultant Episodes for women who have received a primary or secondary operative procedure for the insertion of Transvaginal Mesh, Transobturator Tape, Transvaginal Slings and Transvaginal Tape.
Procedure | 2010-11 | 2011-12 | 2012-13 |
Insertion of Transvaginal Mesh | 1,636 | 1,524 | 1,310 |
Insertion of Transobturator Tape | 5,426 | 4,885 | 4,476 |
Insertion of Transvaginal Sling | 130 | 134 | 135 |
Insertion of Transvaginal Tape | 8,087 | 8,172 | 7,627 |
Source: Hospital Episode Statistics (HES), Health and Social Care Information Centre.
Note: Activity in English NHS Hospitals and English NHS commissioned activity in the independent sector.
Adverse events reported to MHRA by Health Professionals concerning Vaginal tape and mesh implants are as follows
Vaginal Tapes for Stress Urinary Incontinence | Vaginal Mesh for Pelvic Organ Prolapse | Vaginal Mesh for unknown* indication | |
2011 | 3 | 1 | 0 |
2012 | 23 | 31 | 2 |
2013 | 27 | 20 | 0 |
Up to March 2014 | 16 | 7 | 0 |
*The reporter did not provide enough information on what type of mesh it was
Number of patient safety incidents relating to mesh used in gynaecological procedures reported to the NRLS (Year of occurrence by reported degree of harm)
| No Harm | Low | Moderate | TOTAL |
2011 | 0 | 2 | 4 | 6 |
2012 | 7 | 4 | 3 | 14 |
2013 | 4 | 1 | 1 | 6 |
TOTAL | 11 | 7 | 8 | 26 |
Search strategy: All incidents from gynaecological specialties in the NRLS were searched on 2 December 2013 for the keyword ‘mesh'
Adverse events reported to MHRA by patients/members of the public concerning Vaginal tape and mesh implants are as follows
Vaginal Tapes for Stress Urinary Incontinence | Vaginal Mesh for Pelvic Organ Prolapse | Vaginal Mesh for unknown* indication | |
2011 | 33 | 7 | 3 |
2012 | 26 | 2 | 0 |
2013 | 30 | 10 | 3 |
Up to March 2014 | 7 | 0 | 0 |
*The reporter did not provide enough information on what type of mesh it was
No incidents relating to transvaginal mesh have been reported to the NRLS by patients.
The Department has answered 11 previous Parliamentary Questions, 27 letters from hon. Members and Peers and 17 letters from members of the public since 1 September 2011. The Chief Executive of the MHRA has replied to six letters from hon. Members since 1 September 2011.
Asked by: Graeme Morrice (Labour - Livingston)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, how many patients have received polypropylene transvaginal mesh implants through the NHS in each of the last three years.
Answered by Norman Lamb
The Department of Health does not hold information on the number of patients who have required further operations due to complications with transvaginal mesh implants in each of the last three years or the costs of these operations.
The Department has had two meetings in which polypropylene transvaginal mesh implants were either discussed or on the agenda.
NHS England manages the National Reporting and Learning System (NRLS) for patient safety incident reports from the NHS. NHS England shares incident reports concerning harms arising from medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA).
Manufacturers of medical devices such as transvaginal mesh implants are legally required to report adverse incidents (ie death, serious injury or potential serious injury) involving their devices to the MHRA. General Medical Guidance published in February 2013 makes it clear that clinicians should report medical device incidents to the MHRA, and make information available to patients about how they can report side effects to the MHRA. The MHRA also encourages voluntary reporting of adverse incidents by healthcare workers, carers, patients and members of the public and participates in monthly telephone meetings with regulators in other European Union member states to share information about medical device safety.
The Department is currently engaged in work to assess the effectiveness of existing arrangements for reporting complications relating to transvaginal mesh implants. NHS England is leading this work, which also involves the MHRA, the Royal College of Obstetricians and Gynaecologists, and the relevant professional societies (the British Society of Urogynaecology and the British Association of Urological Surgeons).
Finished Consultant Episodes for women who have received a primary or secondary operative procedure for the insertion of Transvaginal Mesh, Transobturator Tape, Transvaginal Slings and Transvaginal Tape.
Procedure | 2010-11 | 2011-12 | 2012-13 |
Insertion of Transvaginal Mesh | 1,636 | 1,524 | 1,310 |
Insertion of Transobturator Tape | 5,426 | 4,885 | 4,476 |
Insertion of Transvaginal Sling | 130 | 134 | 135 |
Insertion of Transvaginal Tape | 8,087 | 8,172 | 7,627 |
Source: Hospital Episode Statistics (HES), Health and Social Care Information Centre.
Note: Activity in English NHS Hospitals and English NHS commissioned activity in the independent sector.
Adverse events reported to MHRA by Health Professionals concerning Vaginal tape and mesh implants are as follows
Vaginal Tapes for Stress Urinary Incontinence | Vaginal Mesh for Pelvic Organ Prolapse | Vaginal Mesh for unknown* indication | |
2011 | 3 | 1 | 0 |
2012 | 23 | 31 | 2 |
2013 | 27 | 20 | 0 |
Up to March 2014 | 16 | 7 | 0 |
*The reporter did not provide enough information on what type of mesh it was
Number of patient safety incidents relating to mesh used in gynaecological procedures reported to the NRLS (Year of occurrence by reported degree of harm)
| No Harm | Low | Moderate | TOTAL |
2011 | 0 | 2 | 4 | 6 |
2012 | 7 | 4 | 3 | 14 |
2013 | 4 | 1 | 1 | 6 |
TOTAL | 11 | 7 | 8 | 26 |
Search strategy: All incidents from gynaecological specialties in the NRLS were searched on 2 December 2013 for the keyword ‘mesh'
Adverse events reported to MHRA by patients/members of the public concerning Vaginal tape and mesh implants are as follows
Vaginal Tapes for Stress Urinary Incontinence | Vaginal Mesh for Pelvic Organ Prolapse | Vaginal Mesh for unknown* indication | |
2011 | 33 | 7 | 3 |
2012 | 26 | 2 | 0 |
2013 | 30 | 10 | 3 |
Up to March 2014 | 7 | 0 | 0 |
*The reporter did not provide enough information on what type of mesh it was
No incidents relating to transvaginal mesh have been reported to the NRLS by patients.
The Department has answered 11 previous Parliamentary Questions, 27 letters from hon. Members and Peers and 17 letters from members of the public since 1 September 2011. The Chief Executive of the MHRA has replied to six letters from hon. Members since 1 September 2011.