Asked by: Graeme Morrice (Labour - Livingston)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what processes his Department and the NHS have in place to monitor the safety of 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 required further operations due to complications with transvaginal mesh implants in each of the last three years; and what the cost of such procedures was.
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, what meetings his Department has had in which polypropylene transvaginal mesh implants were (a) discussed or (b) on the agenda.
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, whether his Department has any plans to end the employee trade union membership dues check-off system.
Answered by Dan Poulter
In accordance with a request from the Minister for the Cabinet Office, the Department and its executive agencies (Medicines and Healthcare products Regulatory Agency and Public Health England) have undertaken a review of the provision of the check-off facility. Upon completion, this review will be submitted to the Secretary of State for consideration.